{ "meta": { "total_records": 2701, "timestamp": "2026-06-02T18:20:28Z" }, "data": [ { "category": "Human", "name_of_medicine": "Theralugand", "ema_product_number": "EMEA/H/C/005882", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000348134", "international_non_proprietary_name_common_name": "lutetium (177Lu) chloride", "active_substance": "lutetium (177Lu) chloride", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V10X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other therapeutic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Theralugand is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eckert & Ziegler Radiopharma GmbH", "european_commission_decision_date": "02/06/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "20/09/2024", "last_updated_date": "02/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/theralugand" }, { "category": "Human", "name_of_medicine": "Orkambi", "ema_product_number": "EMEA/H/C/003954", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000296584", "international_non_proprietary_name_common_name": "lumacaftor;ivacaftor", "active_substance": "Lumacaftor;ivacaftor", "therapeutic_area_mesh": "Cystic Fibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R07AX30", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other respiratory system products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene. Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vertex Pharmaceuticals (Ireland) Limited", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "09/03/2023", "last_updated_date": "02/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orkambi" }, { "category": "Human", "name_of_medicine": "Pazenir", "ema_product_number": "EMEA/H/C/004441", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000348639", "international_non_proprietary_name_common_name": "paclitaxel", "active_substance": "paclitaxel", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pazenir monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Pazenir in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ratiopharm GmbH", "european_commission_decision_date": "02/06/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/02/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/05/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "23/05/2019", "last_updated_date": "02/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pazenir" }, { "category": "Human", "name_of_medicine": "Opdivo", "ema_product_number": "EMEA/H/C/003985", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000304938", "international_non_proprietary_name_common_name": "nivolumab", "active_substance": "nivolumab", "therapeutic_area_mesh": "Melanoma;Hodgkin Disease;Carcinoma, Renal Cell;Carcinoma, Non-Small-Cell Lung;Carcinoma, Transitional Cell;Squamous Cell Carcinoma of Head and Neck;Urologic Neoplasms;Mesothelioma;Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FF01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Melanoma Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Opdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1). Non-small cell lung cancer (NSCLC) Opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. Neoadjuvant treatment of NSCLC Opdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria). Neoadjuvant and adjuvant treatment of NSCLC Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria). Malignant pleural mesothelioma (MPM) Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Renal cell carcinoma (RCC) Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (see section 5.1). Classical Hodgkin lymphoma (cHL) Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma. Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Opdivo in combination with brentuximab vedotin is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy (see section 5.1). Squamous cell cancer of the head and neck (SCCHN) Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1). Urothelial carcinoma Opdivo in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. Opdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. Adjuvant treatment of urothelial carcinoma Opdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC (see section 5.1). Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) Opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings:- first-line treatment of unresectable or metastatic colorectal cancer;- treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%. Opdivo in combination with fluoropyrimidine‑ and platinum‑based combination chemotherapy is indicated for the first‑line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD‑L1 expression ≥ 1%. Opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine‑ and platinum‑based combination chemotherapy. Adjuvant treatment of oesophageal or gastro‑oesophageal junction cancer (OC or GEJC) Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro‑oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (see section 5.1). Gastric, gastro‑oesophageal junction (GEJ) or oesophageal adenocarcinoma Opdivo in combination with fluoropyrimidine‑ and platinum‑based combination chemotherapy is indicated for the first‑line treatment of adult patients with HER2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express PD‑L1 with a combined positive score (CPS) ≥ 5. Hepatocellular carcinoma (HCC) Opdivo in combination with ipilimumab is indicated for the first‑line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "28/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/06/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "74", "first_published_date": "30/07/2018", "last_updated_date": "02/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opdivo" }, { "category": "Human", "name_of_medicine": "Zandoriah", "ema_product_number": "EMEA/H/C/006688", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "teriparatide", "active_substance": "teriparatide", "therapeutic_area_mesh": "Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Teriparatide is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CinnaGen Co Unipessoal LDA", "european_commission_decision_date": "27/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/04/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "02/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zandoriah" }, { "category": "Human", "name_of_medicine": "Akynzeo", "ema_product_number": "EMEA/H/C/003728", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000341259", "international_non_proprietary_name_common_name": "netupitant;palonosetron", "active_substance": "netupitant;palonosetron hydrochloride", "therapeutic_area_mesh": "Vomiting;Neoplasms;Nausea;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A04AA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiemetics and antinauseants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Akynzeo is indicated in adults for the: Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy. Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Helsinn Birex Pharmaceuticals Ltd", "european_commission_decision_date": "01/06/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/05/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "12/04/2018", "last_updated_date": "02/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/akynzeo" }, { "category": "Human", "name_of_medicine": "Emadine", "ema_product_number": "EMEA/H/C/000223", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000340426", "international_non_proprietary_name_common_name": "emedastine", "active_substance": "emedastine difumarate", "therapeutic_area_mesh": "Conjunctivitis, Allergic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01GX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of seasonal allergic conjunctivitis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Immedica Pharma AB", "european_commission_decision_date": "29/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/01/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "23/04/2018", "last_updated_date": "01/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emadine" }, { "category": "Human", "name_of_medicine": "Jinarc", "ema_product_number": "EMEA/H/C/002788", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000246866", "international_non_proprietary_name_common_name": "tolvaptan", "active_substance": "tolvaptan", "therapeutic_area_mesh": "Polycystic Kidney, Autosomal Dominant", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C03XA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diuretics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Otsuka Pharmaceutical Netherlands B.V.", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/05/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "26/07/2018", "last_updated_date": "01/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jinarc" }, { "category": "Human", "name_of_medicine": "Capvaxive", "ema_product_number": "EMEA/H/C/006267", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000294070", "international_non_proprietary_name_common_name": "pneumococcal polysaccharide conjugate vaccine (21-valent)", "active_substance": "pneumococcal polysaccharide serotype 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B de-O-acetylated, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B conjugated to CRM197 carrier protein", "therapeutic_area_mesh": "Pneumococcal Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AL02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Capvaxive is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae Capvaxive is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.   Capvaxive is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in children and adolescents 2 to less than 18 years of age who previously completed a primary paediatric pneumococcal vaccination regimen. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.  The use of Capvaxive should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "30/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/03/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "31/01/2025", "last_updated_date": "01/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/capvaxive" }, { "category": "Human", "name_of_medicine": "Zepzelca", "ema_product_number": "EMEA/H/C/006673", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "lurbinectedin", "active_substance": "lurbinectedin", "therapeutic_area_mesh": "Small Cell Lung Carcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX69", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zepzelca, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharma Mar S.A.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/05/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/03/2026", "last_updated_date": "01/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zepzelca" }, { "category": "Human", "name_of_medicine": "Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan)", "ema_product_number": "EMEA/H/C/004025", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000327968", "international_non_proprietary_name_common_name": "lopinavir;ritonavir", "active_substance": "lopinavir;ritonavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years. The choice of lopinavir/ritonavir to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "29/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/01/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "14/06/2018", "last_updated_date": "01/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lopinavir-ritonavir-viatris" }, { "category": "Human", "name_of_medicine": "Eurneffy", "ema_product_number": "EMEA/H/C/006139", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000348363", "international_non_proprietary_name_common_name": "epinephrine", "active_substance": "epinephrine", "therapeutic_area_mesh": "Anaphylaxis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01CA24", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eurneffy is indicated in the emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens as well as idiopathic or exercise induced anaphylaxis. Treatment is indicated for adults and children aged 4 years and over with a body weight of 15 kg or more.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ALK-Abelló A/S", "european_commission_decision_date": "28/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "28/06/2024", "last_updated_date": "01/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eurneffy" }, { "category": "Human", "name_of_medicine": "Abrysvo", "ema_product_number": "EMEA/H/C/006027", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000348361", "international_non_proprietary_name_common_name": "respiratory syncytial virus vaccine (bivalent, recombinant)", "active_substance": "respiratory syncytial virus vaccine (bivalent, recombinant)", "therapeutic_area_mesh": "Respiratory Syncytial Virus Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other viral vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Abrysvo is indicated for: Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy.  Active immunisation of individuals 18 years of age and older for the prevention of lower respiratory tract disease caused by RSV. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "Yes", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "01/06/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "17/07/2023", "last_updated_date": "01/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abrysvo" }, { "category": "Human", "name_of_medicine": "Nemluvio", "ema_product_number": "EMEA/H/C/006149", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000309230", "international_non_proprietary_name_common_name": "nemolizumab", "active_substance": "nemolizumab", "therapeutic_area_mesh": "Dermatitis, Atopic;Prurigo", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D11AH12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other dermatological preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Atopic dermatitis (AD) Nemluvio is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy. Prurigo nodularis (PN) Nemluvio is indicated for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Galderma International", "european_commission_decision_date": "28/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "13/12/2024", "last_updated_date": "01/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nemluvio" }, { "category": "Human", "name_of_medicine": "Carvykti", "ema_product_number": "EMEA/H/C/005095", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000311150", "international_non_proprietary_name_common_name": "ciltacabtagene autoleucel", "active_substance": "ciltacabtagene autoleucel", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XL05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "28/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/03/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/05/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "25/03/2022", "last_updated_date": "01/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/carvykti" }, { "category": "Human", "name_of_medicine": "Imatinib Accord", "ema_product_number": "EMEA/H/C/002681", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000348145", "international_non_proprietary_name_common_name": "imatinib", "active_substance": "imatinib", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma;Dermatofibrosarcoma;Myelodysplastic-Myeloproliferative Diseases;Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Hypereosinophilic Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "imatinib", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imatinib Accord is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.  adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.  adult patients with relapsed or refractory Ph+ ALL as monotherapy.  adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.  adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR? rearrangement.  adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).  the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.  Patients who have a low or very low risk of recurrence should not receive adjuvant treatment The effect of imatinib on the outcome of bone marrow transplantation has not been determined. In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "28/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/06/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "16/05/2017", "last_updated_date": "01/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imatinib-accord" }, { "category": "Human", "name_of_medicine": "Kapruvia", "ema_product_number": "EMEA/H/C/005612", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000311151", "international_non_proprietary_name_common_name": "difelikefalin", "active_substance": "difelikefalin", "therapeutic_area_mesh": "Pruritus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kapruvia is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vifor Fresenius Medical Care Renal Pharma France", "european_commission_decision_date": "28/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/04/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "22/02/2022", "last_updated_date": "01/06/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kapruvia" }, { "category": "Human", "name_of_medicine": "Optison", "ema_product_number": "EMEA/H/C/000166", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0074", "international_non_proprietary_name_common_name": "perflutren", "active_substance": "perflutren", "therapeutic_area_mesh": "Echocardiography", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V08DA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Contrast media", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation. Optison should only be used in patients where the study without contrast enhancement is inconclusive.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GE Healthcare AS", "european_commission_decision_date": "19/05/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/05/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "08/05/2014", "last_updated_date": "29/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/optison" }, { "category": "Human", "name_of_medicine": "Caprelsa", "ema_product_number": "EMEA/H/C/002315", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000340014", "international_non_proprietary_name_common_name": "vandetanib", "active_substance": "vandetanib", "therapeutic_area_mesh": "Thyroid Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic and immunomodulating agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is indicated in adults, children and adolescents aged 5 years and older. For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Esteve Pharmaceuticals, S.A.", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/11/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/02/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "31/05/2018", "last_updated_date": "29/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/caprelsa" }, { "category": "Human", "name_of_medicine": "Ranluspec", "ema_product_number": "EMEA/H/C/006502", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000342644", "international_non_proprietary_name_common_name": "ranibizumab", "active_substance": "ranibizumab", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetic Retinopathy;Diabetes Complications;Retinal Vein Occlusion;Choroidal Neovascularization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ranluspec is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative diabetic retinopathy (PDR) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) The treatment of visual impairment due to choroidal neovascularisation (CNV) ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lupin Europe GmbH", "european_commission_decision_date": "29/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/12/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/02/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "12/12/2025", "last_updated_date": "29/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ranluspec" }, { "category": "Human", "name_of_medicine": "Tysabri", "ema_product_number": "EMEA/H/C/000603", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315289", "international_non_proprietary_name_common_name": "natalizumab", "active_substance": "natalizumab", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Monoclonal antibodies", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: Patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biogen Netherlands B.V.", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/06/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "52", "first_published_date": "02/08/2018", "last_updated_date": "29/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tysabri" }, { "category": "Human", "name_of_medicine": "Teriflunomide Viatris (previously Teriflunomide Mylan)", "ema_product_number": "EMEA/H/C/005962", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325417", "international_non_proprietary_name_common_name": "teriflunomide", "active_substance": "teriflunomide", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AK02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants;Dihydroorotate dehydrogenase (DHODH) inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 of the SmPC for important information on the population for which efficacy has been established).  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "14/09/2022", "last_updated_date": "29/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/teriflunomide-viatris" }, { "category": "Human", "name_of_medicine": "Ozurdex", "ema_product_number": "EMEA/H/C/001140", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000307245", "international_non_proprietary_name_common_name": "dexamethasone", "active_substance": "dexamethasone", "therapeutic_area_mesh": "Macular Edema;Uveitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01BA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals;Other ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO). Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis. Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "06/04/2018", "last_updated_date": "29/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ozurdex" }, { "category": "Human", "name_of_medicine": "Vyepti", "ema_product_number": "EMEA/H/C/005287", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000324932", "international_non_proprietary_name_common_name": "eptinezumab", "active_substance": "Eptinezumab", "therapeutic_area_mesh": "Migraine Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02CD", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vyepti is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "H. Lundbeck A/S", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/11/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/01/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "11/11/2021", "last_updated_date": "29/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vyepti" }, { "category": "Human", "name_of_medicine": "Comirnaty", "ema_product_number": "EMEA/H/C/005735", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320534", "international_non_proprietary_name_common_name": "COVID-19 mRNA vaccine", "active_substance": "single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BN01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Comirnaty JN.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Comirnaty JN.1 concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in infants and children aged 6 months to 11 years. The use of this vaccine should be in accordance with official recommendations. Comirnaty KP.2 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Comirnaty LP.8.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioNTech Manufacturing GmbH", "european_commission_decision_date": "26/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/12/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "62", "first_published_date": "23/12/2020", "last_updated_date": "29/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty" }, { "category": "Human", "name_of_medicine": "Adtralza", "ema_product_number": "EMEA/H/C/005255", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000343070", "international_non_proprietary_name_common_name": "tralokinumab", "active_substance": "", "therapeutic_area_mesh": "Dermatitis, Atopic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other dermatological preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adtralza is indicated for the treatment of moderate to severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "LEO Pharma A/S", "european_commission_decision_date": "28/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/06/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "20/04/2021", "last_updated_date": "28/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adtralza" }, { "category": "Human", "name_of_medicine": "Pomalidomide Teva", "ema_product_number": "EMEA/H/C/006302", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000322664", "international_non_proprietary_name_common_name": "pomalidomide", "active_substance": "Pomalidomide", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pomalidomide Teva in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Teva in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva GmbH", "european_commission_decision_date": "28/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "20/09/2024", "last_updated_date": "28/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-teva" }, { "category": "Human", "name_of_medicine": "Camcevi", "ema_product_number": "EMEA/H/C/005034", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "X/0000258054", "international_non_proprietary_name_common_name": "leuprorelin", "active_substance": "leuprorelin mesilate", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "20/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/03/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/05/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "20/06/2022", "last_updated_date": "28/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/camcevi" }, { "category": "Human", "name_of_medicine": "Fubelv", "ema_product_number": "EMEA/H/C/006738", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "etanercept", "active_substance": "etanercept", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Juvenile;Arthritis, Psoriatic;Axial Spondyloarthritis;Non-Radiographic Axial Spondyloarthritis;Spondylitis, Ankylosing;Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "etanercept", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritisFubelv in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.Fubelv can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Fubelv is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.Fubelv, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.Juvenile idiopathic arthritisTreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Psoriatic arthritisTreatment of active and progressive psoriatic arthritis in adults when the response to previous disease- modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritisAnkylosing spondylitisTreatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.Non-radiographic axial spondyloarthritisTreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).Plaque psoriasisTreatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).Paediatric plaque psoriasisTreatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "28/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fubelv" }, { "category": "Human", "name_of_medicine": "Joenja", "ema_product_number": "EMEA/H/C/005927", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "leniolisib", "active_substance": "leniolisib phosphate", "therapeutic_area_mesh": "Primary Immunodeficiency Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AX22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Joenja is indicated for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharming Technologies B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/05/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/03/2026", "last_updated_date": "28/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/joenja" }, { "category": "Human", "name_of_medicine": "Aquipta", "ema_product_number": "EMEA/H/C/005871", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315259", "international_non_proprietary_name_common_name": "atogepant", "active_substance": "atogepant", "therapeutic_area_mesh": "Migraine Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02CD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/06/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/08/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "19/06/2023", "last_updated_date": "28/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aquipta" }, { "category": "Human", "name_of_medicine": "Spikevax (previously COVID-19 Vaccine Moderna)", "ema_product_number": "EMEA/H/C/005791", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316350", "international_non_proprietary_name_common_name": "COVID-19 mRNA vaccine", "active_substance": "single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BN01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax bivalent Original/Omicron BA.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against COVID-19. The use of this vaccine should be in accordance with official recommendations. Spikevax bivalent Original/Omicron BA.4-5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax XBB.1.5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax LP.8.1 is indicated for active immunisation to prevent COVID 19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Moderna Biotech Spain, S.L.", "european_commission_decision_date": "20/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "04/01/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/01/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "61", "first_published_date": "20/01/2021", "last_updated_date": "28/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax" }, { "category": "Human", "name_of_medicine": "Beromun", "ema_product_number": "EMEA/H/C/000206", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000342387", "international_non_proprietary_name_common_name": "tasonermin", "active_substance": "tasonermin", "therapeutic_area_mesh": "Sarcoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AX11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Beromun is indicated in adults as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft-tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated-limb perfusion (ILP).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Belpharma s.a.", "european_commission_decision_date": "26/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/04/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "14/01/2017", "last_updated_date": "28/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/beromun" }, { "category": "Human", "name_of_medicine": "Calquence", "ema_product_number": "EMEA/H/C/005299", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000332092", "international_non_proprietary_name_common_name": "acalabrutinib", "active_substance": "acalabrutinib;acalabrutinib maleate", "therapeutic_area_mesh": "Leukemia, Lymphocytic, Chronic, B-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EL02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "26/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "05/11/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/11/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "11/11/2020", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/calquence" }, { "category": "Human", "name_of_medicine": "Verzenios", "ema_product_number": "EMEA/H/C/004302", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000307389", "international_non_proprietary_name_common_name": "abemaciclib", "active_substance": "abemaciclib", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EF03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Early Breast Cancer Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence (see section 5.1). In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or Metastatic Breast Cancer Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "29/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "29/10/2018", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/verzenios" }, { "category": "Human", "name_of_medicine": "Qdenga", "ema_product_number": "EMEA/H/C/005155", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000311184", "international_non_proprietary_name_common_name": "dengue tetravalent vaccine (live, attenuated)", "active_substance": "Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated;Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated;Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated;Dengue virus, serotype 2, live, attenuated", "therapeutic_area_mesh": "Dengue", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age. The use of Qdenga should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland Branch", "european_commission_decision_date": "26/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/12/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "12/10/2022", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qdenga" }, { "category": "Human", "name_of_medicine": "Sunosi", "ema_product_number": "EMEA/H/C/004893", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000348654", "international_non_proprietary_name_common_name": "solriamfetol", "active_substance": "solriamfetol hydrochloride", "therapeutic_area_mesh": "Narcolepsy;Sleep Apnea, Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06BA14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy). Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP). ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Atnahs Pharma Netherlands B.V.", "european_commission_decision_date": "27/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "12/02/2020", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sunosi" }, { "category": "Human", "name_of_medicine": "Xenleta", "ema_product_number": "EMEA/H/C/005048", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000247534", "international_non_proprietary_name_common_name": "lefamulin", "active_substance": "lefamulin acetate", "therapeutic_area_mesh": "Pneumonia, Bacterial;Community-Acquired Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01XX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xenleta is indicated for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Venipharm", "european_commission_decision_date": "14/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/07/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "06/08/2020", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xenleta" }, { "category": "Human", "name_of_medicine": "Opdualag", "ema_product_number": "EMEA/H/C/005481", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000303785", "international_non_proprietary_name_common_name": "relatlimab;nivolumab", "active_substance": "nivolumab;relatlimab", "therapeutic_area_mesh": "Melanoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FY02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD L1 expression < 1%.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "18/07/2022", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opdualag" }, { "category": "Human", "name_of_medicine": "Poherdy", "ema_product_number": "EMEA/H/C/006583", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000348769", "international_non_proprietary_name_common_name": "pertuzumab", "active_substance": "pertuzumab", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Early breast cancerPoherdy is indicated for use in combination with trastuzumab and chemotherapy in:- the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence- the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrenceMetastatic breast cancerPoherdy is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "27/02/2026", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/poherdy" }, { "category": "Human", "name_of_medicine": "Yesintek", "ema_product_number": "EMEA/H/C/006444", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000321399", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Psoriasis;Arthritis, Psoriatic;Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Plaque psoriasisYesintek is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A). Paediatric plaque psoriasisYesintek is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA)Yesintek, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Adult Crohn’s DiseaseYesintek is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with lost response to, or were intolerant to either conventional therapy or a TNFα (tumor necrosis factor alpha) antagonist or have medical contraindications to such therapies Paediatric Crohn's Disease (applicable only for vial and PFS presentations)Yesintek is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "13/12/2024", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yesintek" }, { "category": "Human", "name_of_medicine": "Cablivi", "ema_product_number": "EMEA/H/C/004426", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000335378", "international_non_proprietary_name_common_name": "caplacizumab", "active_substance": "Caplacizumab", "therapeutic_area_mesh": "Purpura, Thrombotic Thrombocytopenic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01A", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ablynx NV", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/05/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/08/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "31/08/2018", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cablivi" }, { "category": "Human", "name_of_medicine": "Tevimbra", "ema_product_number": "EMEA/H/C/005919", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000290059", "international_non_proprietary_name_common_name": "tislelizumab", "active_substance": "tislelizumab", "therapeutic_area_mesh": "Esophageal Squamous Cell Carcinoma;Carcinoma, Non-Small-Cell Lung;Small Cell Lung Carcinoma;Nasopharyngeal Carcinoma;Stomach Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FF09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Non-small cell lung cancer (NSCLC) Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1).Tevimbra in combination with pemetrexed and platinum containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC  whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have: locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC. Tevimbra in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous NSCLC who have: locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC. Tevimbra as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab. Small Cell Lung Cancer (SCLC)Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC. Gastric or gastroesophageal junction (G/GEJ) adenocarcinomaTevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1).Oesophageal squamous cell carcinoma (OSCC)Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD L1 with a TAP score ≥ 5% (see section 5.1).Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic OSCC after prior platinum-based chemotherapy. Nasopharyngeal carcinoma (NPC)Tevimbra, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Beone Medicines Ireland Limited", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "17/07/2023", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tevimbra" }, { "category": "Human", "name_of_medicine": "Otulfi", "ema_product_number": "EMEA/H/C/006544", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000343407", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Crohn Disease;Colitis, Ulcerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Plaque psoriasisOtulfi is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A). Paediatric plaque psoriasisOtulfi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, and who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA)Otulfi, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease- modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Adult Crohn’s DiseaseOtulfi is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Paediatric Crohn's DiseaseOtulfi is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Crohn’s DiseaseOtulfi is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "27/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "26/07/2024", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/otulfi" }, { "category": "Human", "name_of_medicine": "Polivy", "ema_product_number": "EMEA/H/C/004870", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000296524", "international_non_proprietary_name_common_name": "polatuzumab vedotin", "active_substance": "polatuzumab vedotin", "therapeutic_area_mesh": "Lymphoma, B-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant. Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "27/01/2020", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/polivy" }, { "category": "Human", "name_of_medicine": "Rezdiffra", "ema_product_number": "EMEA/H/C/006220", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000326759", "international_non_proprietary_name_common_name": "resmetirom", "active_substance": "resmetirom", "therapeutic_area_mesh": "Non-alcoholic Fatty Liver Disease;Liver Cirrhosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bile and liver therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Madrigal Pharmaceuticals EU Limited", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/06/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "20/06/2025", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rezdiffra" }, { "category": "Human", "name_of_medicine": "Trumenba", "ema_product_number": "EMEA/H/C/004051", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320718", "international_non_proprietary_name_common_name": "meningococcal group b vaccine (recombinant, adsorbed)", "active_substance": "Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B", "therapeutic_area_mesh": "Meningitis, Meningococcal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AH09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bacterial vaccines;Meningococcal vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/05/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "11/04/2018", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trumenba" }, { "category": "Human", "name_of_medicine": "Imcivree", "ema_product_number": "EMEA/H/C/005089", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000288021", "international_non_proprietary_name_common_name": "setmelanotide", "active_substance": "setmelanotide", "therapeutic_area_mesh": "Obesity", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A08AA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiobesity preparations, excl. diet products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet Biedl syndrome (BBS), loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Rhythm Pharmaceuticals Netherlands B.V.", "european_commission_decision_date": "30/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/07/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "19/05/2021", "last_updated_date": "27/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree" }, { "category": "Human", "name_of_medicine": "Avonex", "ema_product_number": "EMEA/H/C/000102", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320809", "international_non_proprietary_name_common_name": "interferon beta-1a", "active_substance": "", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Avonex is indicated for the treatment of: patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; Avonex slows the progression of disability and decreases the frequency of relapses; patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite MS. Avonex should be discontinued in patients who develop progressive MS.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biogen Netherlands B.V. ", "european_commission_decision_date": "16/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/03/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "41", "first_published_date": "21/05/2017", "last_updated_date": "26/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/avonex" }, { "category": "Human", "name_of_medicine": "Pomalidomide Zentiva", "ema_product_number": "EMEA/H/C/006294", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000341639", "international_non_proprietary_name_common_name": "pomalidomide", "active_substance": "Pomalidomide", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adults with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Zentiva in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva, k.s.", "european_commission_decision_date": "26/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/07/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "31/05/2024", "last_updated_date": "26/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-zentiva" }, { "category": "Human", "name_of_medicine": "Fycompa", "ema_product_number": "EMEA/H/C/002434", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000311160", "international_non_proprietary_name_common_name": "perampanel", "active_substance": "perampanel", "therapeutic_area_mesh": "Epilepsies, Partial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics;Other antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy. Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eisai GmbH", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/05/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/07/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "23/04/2018", "last_updated_date": "26/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fycompa" }, { "category": "Human", "name_of_medicine": "Ucedane", "ema_product_number": "EMEA/H/C/004019", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000341449", "international_non_proprietary_name_common_name": "carglumic acid", "active_substance": "carglumic acid", "therapeutic_area_mesh": "Hyperammonemia;Amino Acid Metabolism, Inborn Errors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ucedane is indicated in treatment of: hyperammonaemia due to N-acetylglutamate synthase primary deficiency; Hyperammonaemia due to isovaleric acidaemia; Hyperammonaemia due to methymalonic acidaemia; Hyperammonaemia due to propionic acidaemia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eurocept International BV", "european_commission_decision_date": "20/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/04/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/06/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "19/07/2017", "last_updated_date": "26/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ucedane" }, { "category": "Human", "name_of_medicine": "Adempas", "ema_product_number": "EMEA/H/C/002737", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000333716", "international_non_proprietary_name_common_name": "riociguat", "active_substance": "riociguat", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives for pulmonary arterial hypertension", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with inoperable CTEPH, persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity. Pulmonary arterial hypertension (PAH) AdultsAdempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease. PaediatricsAdempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ? 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists. ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "22/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/01/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/03/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "07/03/2018", "last_updated_date": "22/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adempas" }, { "category": "Human", "name_of_medicine": "Uplizna", "ema_product_number": "EMEA/H/C/005818", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000342120", "international_non_proprietary_name_common_name": "inebilizumab", "active_substance": "inebilizumab", "therapeutic_area_mesh": "Neuromyelitis Optica", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin 4 immunoglobulin G (AQP4-IgG) seropositive (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "22/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/11/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/04/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "11/11/2021", "last_updated_date": "22/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/uplizna" }, { "category": "Veterinary", "name_of_medicine": "Nobivac NXT HC", "ema_product_number": "EMEA/V/C/006702", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "feline calicivirosis and feline viral rhinotracheitis vaccine (live)", "active_substance": "feline herpesvirus 1 (FHV), strain G2620A, live;feline calicivirus (FCV), strain F9, live", "therapeutic_area_mesh": "", "species_veterinary": "Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI06AD03", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For active immunisation of cats against feline calicivirus and feline herpesvirus type 1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobivac-nxt-hc" }, { "category": "Veterinary", "name_of_medicine": "Nobivac NXT HCP", "ema_product_number": "EMEA/V/C/006681", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "felid herpesvirus 1, strain G2620A, live;feline calicivirus, strain F9, live;feline panleucopenia virus, strain MW-1, live", "active_substance": "felid herpesvirus 1, strain G2620A, Live;feline calicivirus (FCV), strain F9, live;feline panleucopenia virus (FPL), strain MW-1, live", "therapeutic_area_mesh": "", "species_veterinary": "Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI06AD04", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For active immunisation of cats against feline herpesvirus type 1, feline calicivirus, feline panleucopenia virus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobivac-nxt-hcp" }, { "category": "Veterinary", "name_of_medicine": "Nobivac NXT HCPCh", "ema_product_number": "EMEA/V/C/006703", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "feline calicivirosis, feline rhinotracheitis, feline panleucopenia and feline chlamydiosis (live) vaccine", "active_substance": "chlamydia felis, strain Baker, live;felid herpesvirus 1, strain G2620A, Live;feline calicivirus (FCV), strain F9, live;feline panleucopenia virus (FPL), strain MW-1, live", "therapeutic_area_mesh": "", "species_veterinary": "Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI06AF01", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For active immunisation of cats against feline herpesvirus type 1 (FHV), feline calicivirus (FCV), feline panleucopenia virus (FPL) and chlamydia felis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobivac-nxt-hcpch" }, { "category": "Human", "name_of_medicine": "Piasky", "ema_product_number": "EMEA/H/C/006061", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296137", "international_non_proprietary_name_common_name": "crovalimab", "active_substance": "Crovalimab", "therapeutic_area_mesh": "Hemoglobinuria, Paroxysmal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AJ07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants, Complement inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Piasky as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH): In patients with haemolysis with clinical symptom(s) indicative of high disease activity. In patients who are clinically stable after having been treated with a complement component 5 (C5) inhibitor for at least the past 6 months.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "17/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "28/06/2024", "last_updated_date": "22/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/piasky" }, { "category": "Human", "name_of_medicine": "Yttriga", "ema_product_number": "EMEA/H/C/000596", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000348646", "international_non_proprietary_name_common_name": "yttrium [90Y] chloride", "active_substance": "yttrium (90Y) chloride", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "To be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.Radiopharmaceutical precursor - Not intended for direct use in patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eckert Ziegler Radiopharma GmbH", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2005", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/01/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "21/07/2014", "last_updated_date": "22/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yttriga" }, { "category": "Human", "name_of_medicine": "Yuvanci", "ema_product_number": "EMEA/H/C/005001", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000348760", "international_non_proprietary_name_common_name": "macitentan;tadalafil", "active_substance": "macitentan;tadalafil", "therapeutic_area_mesh": "Pulmonary Arterial Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KX54", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Yuvanci is indicated as substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of macitentan and tadalafil given concurrently as separate tablets.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "26/07/2024", "last_updated_date": "22/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yuvanci" }, { "category": "Human", "name_of_medicine": "Mekinist", "ema_product_number": "EMEA/H/C/002643", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000340680", "international_non_proprietary_name_common_name": "trametinib", "active_substance": "trametinib", "therapeutic_area_mesh": "Melanoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Melanoma Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1). Adjuvant treatment of melanoma Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection. Non-small cell lung cancer (NSCLC) Trametinib in combination with dabrafenib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation. Differentiated thyroid cancer (DTC) Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "19/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/06/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/06/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "40", "first_published_date": "27/08/2018", "last_updated_date": "22/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mekinist" }, { "category": "Human", "name_of_medicine": "Sephience", "ema_product_number": "EMEA/H/C/006331", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000326565", "international_non_proprietary_name_common_name": "sepiapterin", "active_substance": "sepiapterin", "therapeutic_area_mesh": "Phenylketonurias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX28", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with phenylketonuria (PKU).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "PTC Therapeutics International Limited", "european_commission_decision_date": "16/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "25/04/2025", "last_updated_date": "22/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sephience" }, { "category": "Human", "name_of_medicine": "Jubereq", "ema_product_number": "EMEA/H/C/006398", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000340077", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Neoplasms, Bone Tissue;Giant Cell Tumor of Bone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/03/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "28/03/2025", "last_updated_date": "22/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jubereq" }, { "category": "Human", "name_of_medicine": "Osvyrti", "ema_product_number": "EMEA/H/C/006399", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000340077", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "", "therapeutic_area_mesh": "Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/03/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "28/03/2025", "last_updated_date": "22/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/osvyrti" }, { "category": "Human", "name_of_medicine": "Colchicine Agepha Pharma", "ema_product_number": "EMEA/H/C/006653", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "colchicine", "active_substance": "colchicine", "therapeutic_area_mesh": "Myocardial Infarction;Stroke;Coronary Artery Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M04AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antigout preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in patients with atherosclerotic disease or with multiple risk factors for cardiovascular disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Agepha Pharma s.r.o.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/colchicine-agepha-pharma" }, { "category": "Human", "name_of_medicine": "Deqtynet", "ema_product_number": "EMEA/H/C/006608", "medicine_status": "Opinion", "opinion_status": "Negative", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "copper (64Cu) oxodotreotide", "active_substance": "oxodotreotide", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09IX15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine neoplasms (NENs).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CIS bio international", "european_commission_decision_date": "21/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/deqtynet" }, { "category": "Human", "name_of_medicine": "Jascayd", "ema_product_number": "EMEA/H/C/006405", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "nerandomilast", "active_substance": "nerandomilast", "therapeutic_area_mesh": "Idiopathic Pulmonary Fibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF) and adult patients with Progressive Pulmonary Fibrosis (PPF).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jascayd" }, { "category": "Human", "name_of_medicine": "Ablymico", "ema_product_number": "EMEA/H/C/006620", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "liraglutide", "active_substance": "liraglutide", "therapeutic_area_mesh": "Obesity;Overweight", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Glucagon-like peptide-1 (GLP-1) analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of weight management.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "STADA Arzneimittel AG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ablymico" }, { "category": "Human", "name_of_medicine": "Boey", "ema_product_number": "EMEA/H/C/006420", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "trenibotulinumtoxinE", "active_substance": "trenibotulinumtoxinE", "therapeutic_area_mesh": "Stress, Psychological;Cosmetic Techniques", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "Not yet assigned", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "MUSCLE RELAXANTS;Other muscle relaxants, peripherally acting agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Temporary improvement in the appearance of moderate to severe lines between the eyebrows when these have an important psychological impact in adult patients ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Ltd", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/boey" }, { "category": "Human", "name_of_medicine": "Liraglutide STADA", "ema_product_number": "EMEA/H/C/006615", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "liraglutide", "active_substance": "liraglutide", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Glucagon-like peptide-1 (GLP-1) analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "STADA Arzneimittel AG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/liraglutide-stada" }, { "category": "Human", "name_of_medicine": "Orblid", "ema_product_number": "EMEA/H/C/006392", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Telangiectasia, Hereditary Hemorrhagic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;monoclonal antibodies and antibody drug conjugates", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with hereditary haemorrhagic telangiectasia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoires Delbert", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "21/05/2026", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orblid" }, { "category": "Human", "name_of_medicine": "Veblocema", "ema_product_number": "EMEA/H/C/006901", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "infliximab", "active_substance": "infliximab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Crohn Disease;Colitis, Ulcerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adults with Rheumatoid arthritis, Crohn’s disease or Ulcerative colitis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "08/05/2026", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/veblocema" }, { "category": "Human", "name_of_medicine": "Vijoice", "ema_product_number": "EMEA/H/C/006539", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "alpelisib", "active_substance": "alpelisib", "therapeutic_area_mesh": "Genetic Diseases, Inborn;Growth Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EM03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vijoice" }, { "category": "Human", "name_of_medicine": "Vislyfa", "ema_product_number": "EMEA/H/C/006926", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ranibizumab", "active_substance": "ranibizumab", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications;Retinal Vein Occlusion;Choroidal Neovascularization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adults with of neovascular (wet) age-related macular degeneration (AMD), visual impairment and other retinopathies", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lupin Europe GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vislyfa" }, { "category": "Human", "name_of_medicine": "Etcamah", "ema_product_number": "EMEA/H/C/006494", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "camizestrant", "active_substance": "camizestrant", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of adults with locally advanced or metastatic breast cancer", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB ", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/etcamah" }, { "category": "Human", "name_of_medicine": "Nuwiq", "ema_product_number": "EMEA/H/C/002813", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282297", "international_non_proprietary_name_common_name": "simoctocog alfa", "active_substance": "", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Blood coagulation factors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Nuwiq can be used for all age groups.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Octapharma AB", "european_commission_decision_date": "23/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/07/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "23/03/2018", "last_updated_date": "21/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nuwiq" }, { "category": "Human", "name_of_medicine": "Zoledronic acid Teva", "ema_product_number": "EMEA/H/C/002439", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296337", "international_non_proprietary_name_common_name": "zoledronic acid", "active_substance": "zoledronic acid", "therapeutic_area_mesh": "Fractures, Bone;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "24/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/03/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/08/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "27/02/2018", "last_updated_date": "21/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zoledronic-acid-teva" }, { "category": "Human", "name_of_medicine": "Bavencio", "ema_product_number": "EMEA/H/C/004338", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314741", "international_non_proprietary_name_common_name": "avelumab", "active_substance": "", "therapeutic_area_mesh": "Neuroendocrine Tumors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FF04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antineoplastic agents;Monoclonal antibodies", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Bavencio is indicated as monotherapy for the first?line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum?based chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Europe B.V.", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "31/08/2018", "last_updated_date": "21/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bavencio" }, { "category": "Human", "name_of_medicine": "Exjade", "ema_product_number": "EMEA/H/C/000670", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323869", "international_non_proprietary_name_common_name": "deferasirox", "active_substance": "deferasirox", "therapeutic_area_mesh": "beta-Thalassemia;Iron Overload", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Exjade is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged six years and older. Exjade is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged two to five years; in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged two years and older; in patients with other anaemias aged two years and older. Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "04/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/06/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/08/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "58", "first_published_date": "23/07/2018", "last_updated_date": "21/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exjade" }, { "category": "Human", "name_of_medicine": "Ceprotin", "ema_product_number": "EMEA/H/C/000334", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "H/C/000334", "international_non_proprietary_name_common_name": "human protein C", "active_substance": "human protein C", "therapeutic_area_mesh": "Purpura Fulminans;Protein C Deficiency", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AD12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "CEPROTIN is indicated for prophylaxis and treatment of  purpura fulminans  coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein C deficiency.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Manufacturing Austria AG", "european_commission_decision_date": "03/07/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/07/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "30/08/2017", "last_updated_date": "21/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ceprotin" }, { "category": "Human", "name_of_medicine": "Kisqali", "ema_product_number": "EMEA/H/C/004213", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315309", "international_non_proprietary_name_common_name": "ribociclib", "active_substance": "ribociclib succinate", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EF02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Early breast cancerKisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria).In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.Advanced or metastatic breast cancerKisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/06/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "22/08/2017", "last_updated_date": "21/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kisqali" }, { "category": "Human", "name_of_medicine": "Pyrukynd", "ema_product_number": "EMEA/H/C/005540", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000344092", "international_non_proprietary_name_common_name": "mitapivat", "active_substance": "mitapivat sulfate", "therapeutic_area_mesh": "Genetic Diseases, Inborn;Anemia, Hemolytic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pyrukynd is indicated for the treatment of pyruvate kinase deficiency (PK deficiency) in adult patients (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Agios Netherlands B.V.", "european_commission_decision_date": "20/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "14/09/2022", "last_updated_date": "21/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pyrukynd" }, { "category": "Human", "name_of_medicine": "Ruconest", "ema_product_number": "EMEA/H/C/001223", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0090/G", "international_non_proprietary_name_common_name": "conestat alfa", "active_substance": "recombinant human C1-inhibitor", "therapeutic_area_mesh": "Angioedemas, Hereditary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in hereditary angioedema;Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ruconest is indicated for treatment of acute angioedema attacks in adults with hereditary angioedema (HAE) due to C1-esterase-inhibitor deficiency.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharming Group N.V.", "european_commission_decision_date": "29/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/10/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "10/04/2018", "last_updated_date": "20/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ruconest" }, { "category": "Human", "name_of_medicine": "Feraccru", "ema_product_number": "EMEA/H/C/002733", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0046/G", "international_non_proprietary_name_common_name": "ferric maltol", "active_substance": "ferric maltol", "therapeutic_area_mesh": "Anemia, Iron-Deficiency", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03AB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Feraccru is indicated in adults for the treatment of iron deficiency.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Norgine B.V.", "european_commission_decision_date": "15/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/12/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/02/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "15/06/2018", "last_updated_date": "20/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/feraccru" }, { "category": "Human", "name_of_medicine": "Ryeqo", "ema_product_number": "EMEA/H/C/005267", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000304469", "international_non_proprietary_name_common_name": "relugolix;estradiol;norethisterone acetate", "active_substance": "relugolix;norethisterone acetate;estradiol hemihydrate", "therapeutic_area_mesh": "Leiomyoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01CC54", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ryeqo is indicated in adult women of reproductive age for: - treatment of moderate to severe symptoms of uterine fibroids, - symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/07/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/07/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "19/05/2021", "last_updated_date": "20/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ryeqo" }, { "category": "Human", "name_of_medicine": "Xofluza", "ema_product_number": "EMEA/H/C/004974", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323488", "international_non_proprietary_name_common_name": "baloxavir marboxil", "active_substance": "Baloxavir marboxil", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of influenza Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. Post exposure prophylaxis of influenza Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. Xofluza should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/11/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/01/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "22/01/2021", "last_updated_date": "20/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xofluza" }, { "category": "Human", "name_of_medicine": "Mimpara", "ema_product_number": "EMEA/H/C/000570", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0074", "international_non_proprietary_name_common_name": "cinacalcet", "active_substance": "cinacalcet hydrochloride", "therapeutic_area_mesh": "Hypercalcemia;Parathyroid Neoplasms;Hyperparathyroidism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05BX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Secondary hyperparathyroidism Adults Treatment of secondary hyperparathyroidism (HPT) in adult patients with end stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric population Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate. Parathyroid carcinoma and primary hyperparathyroidism in adults. Reduction of hypercalcaemia in adult patients with: parathyroid carcinoma; primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "03/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/10/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/12/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "04/06/2018", "last_updated_date": "20/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mimpara" }, { "category": "Human", "name_of_medicine": "Iloperidone Vanda Pharmaceuticals", "ema_product_number": "EMEA/H/C/006561", "medicine_status": "Opinion", "opinion_status": "Negative", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "iloperidone", "active_substance": "iloperidone", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of schizophrenia, acute treatment of manic or mixed episodes associated with bipolar I disorder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vanda Pharmaceuticals Netherlands B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "20/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/iloperidone-vanda-pharmaceuticals" }, { "category": "Human", "name_of_medicine": "Dazparda", "ema_product_number": "EMEA/H/C/006187", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "insulin aspart", "active_substance": "insulin aspart", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gan & Lee Pharmaceuticals Europe GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/04/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "20/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dazparda" }, { "category": "Human", "name_of_medicine": "Cerdelga", "ema_product_number": "EMEA/H/C/003724", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PASS/0000287682", "international_non_proprietary_name_common_name": "eliglustat", "active_substance": "Eliglustat (tartrate)", "therapeutic_area_mesh": "Gaucher Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "AdultsCerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).Paediatric population (from 6 to < 18 years of age) weighing ≥ 15 kgCerdelga is indicated for paediatric patients with GD1 who are 6 years and older with a minimum body weight of 15 kg, who are stable on enzyme replacement therapy (ERT), and who are CYP2D6 PMs, IMs or EMs. ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi B.V.", "european_commission_decision_date": "30/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/01/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "07/06/2018", "last_updated_date": "20/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cerdelga" }, { "category": "Human", "name_of_medicine": "Arava", "ema_product_number": "EMEA/H/C/000235", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000309158", "international_non_proprietary_name_common_name": "leflunomide", "active_substance": "leflunomide", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Psoriatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AK01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi-aventis Deutschland GmbH", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/09/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "45", "first_published_date": "09/04/2018", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/arava" }, { "category": "Human", "name_of_medicine": "Synflorix", "ema_product_number": "EMEA/H/C/000973", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000341456", "international_non_proprietary_name_common_name": "pneumococcal polysaccharide conjugate vaccine (adsorbed)", "active_substance": "Pneumococcal polysaccharide serotype 23F;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 5;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 7F;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 1;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19F", "therapeutic_area_mesh": "Pneumococcal Infections;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AL52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age. See sections 4.4 and 5.1 in product information for information on protection against specific pneumococcal serotypes. The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "19/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/03/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "12/10/2017", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/synflorix" }, { "category": "Human", "name_of_medicine": "Tecartus", "ema_product_number": "EMEA/H/C/005102", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308229", "international_non_proprietary_name_common_name": "brexucabtagene autoleucel", "active_substance": "autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel)", "therapeutic_area_mesh": "Lymphoma, Mantle-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mantle cell lymphoma Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Acute lymphoblastic leukaemia Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Kite Pharma EU B.V.", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/10/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/12/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "25/01/2021", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tecartus" }, { "category": "Human", "name_of_medicine": "Cimzia", "ema_product_number": "EMEA/H/C/001037", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310696", "international_non_proprietary_name_common_name": "certolizumab pegol", "active_substance": "certolizumab pegol", "therapeutic_area_mesh": "Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Cimzia, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate. Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. Cimzia has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function, when given in combination with MTX. Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: Ankylosing spondylitis (AS) Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Axial spondyloarthritis without radiographic evidence of AS Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C reactive protein (CRP) and /or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs. Psoriatic arthritis Cimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma", "european_commission_decision_date": "16/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "41", "first_published_date": "19/07/2018", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cimzia" }, { "category": "Human", "name_of_medicine": "Yescarta", "ema_product_number": "EMEA/H/C/004480", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308229", "international_non_proprietary_name_common_name": "axicabtagene ciloleucel", "active_substance": "axicabtagene ciloleucel", "therapeutic_area_mesh": "Lymphoma, Follicular;Lymphoma, Large B-Cell, Diffuse", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX70", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Yescarta is indicated for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy. Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Kite Pharma EU B.V.", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/06/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "23/08/2018", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yescarta" }, { "category": "Human", "name_of_medicine": "Tuyory", "ema_product_number": "EMEA/H/C/006416", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tocilizumab", "active_substance": "tocilizumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Juvenile;Cytokine Release Syndrome;Giant Cell Arteritis;COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis (RA) Tuyory, in combination with methotrexate (MTX), is indicated for:- the treatment of severe, active and progressive RA in adults not previously treated with MTX.- the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease- modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.In these patients, Tuyory can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Coronavirus disease 2019 (COVID-19) Tuyory is indicated for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Systemic juvenile idiopathic arthritis (sJIA) Tuyory is indicated for the treatment of active sJIA in patients 1 year of age and older, who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Tuyory can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.Polyarticular juvenile idiopathic arthritis (pJIA) Tuyory in combination with MTX is indicated for the treatment of pJIA (rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Tuyory can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.Cytokine release syndrome (CRS) Tuyory is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening CRS in adults and paediatric patients 2 years of age and older. Giant cell arteritis (GCA) Tuyory is indicated for the treatment of GCA in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/04/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tuyory" }, { "category": "Human", "name_of_medicine": "Tafinlar", "ema_product_number": "EMEA/H/C/002604", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000278305", "international_non_proprietary_name_common_name": "dabrafenib", "active_substance": "dabrafenib mesilate", "therapeutic_area_mesh": "Melanoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Melanoma Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection. Non-small cell lung cancer (NSCLC) Dabrafenib in combination with trametinib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation. Differentiated thyroid cancer (DTC) Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "30/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "40", "first_published_date": "27/08/2018", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tafinlar" }, { "category": "Human", "name_of_medicine": "Spexotras", "ema_product_number": "EMEA/H/C/005886", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000340747", "international_non_proprietary_name_common_name": "trametinib", "active_substance": "trametinib dimethyl sulfoxide", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Low-grade glioma Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. High-grade glioma Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "19/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/01/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "10/11/2023", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/spexotras" }, { "category": "Human", "name_of_medicine": "Voranigo", "ema_product_number": "EMEA/H/C/006284", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316249", "international_non_proprietary_name_common_name": "vorasidenib", "active_substance": "vorasidenib", "therapeutic_area_mesh": "Oligodendroglioma;Astrocytoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XM04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Voranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "25/07/2025", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/voranigo" }, { "category": "Human", "name_of_medicine": "Procysbi", "ema_product_number": "EMEA/H/C/002465", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000293006", "international_non_proprietary_name_common_name": "mercaptamine", "active_substance": "mercaptamine bitartrate", "therapeutic_area_mesh": "Cystinosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Procysbi is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A", "european_commission_decision_date": "05/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "26/07/2018", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/procysbi" }, { "category": "Human", "name_of_medicine": "Arexvy", "ema_product_number": "EMEA/H/C/006054", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000309343", "international_non_proprietary_name_common_name": "Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted)", "active_substance": "", "therapeutic_area_mesh": "Respiratory Syncytial Virus Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other viral vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 18 years of age and older.  The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "16/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/06/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "16/06/2023", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/arexvy" }, { "category": "Human", "name_of_medicine": "Zoledronic acid medac", "ema_product_number": "EMEA/H/C/002359", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00003149/202308", "international_non_proprietary_name_common_name": "zoledronic acid", "active_substance": "zoledronic acid monohydrate", "therapeutic_area_mesh": "Fractures, Bone;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "european_commission_decision_date": "27/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/05/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/08/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/03/2026", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "16/06/2017", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zoledronic-acid-medac" }, { "category": "Human", "name_of_medicine": "Ibrance", "ema_product_number": "EMEA/H/C/003853", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/PAM/0000327049", "international_non_proprietary_name_common_name": "palbociclib", "active_substance": "Palbociclib", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EF01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "06/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "30/07/2018", "last_updated_date": "19/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ibrance" }, { "category": "Human", "name_of_medicine": "Ixchiq", "ema_product_number": "EMEA/H/C/005797", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315586", "international_non_proprietary_name_common_name": "Chikungunya vaccine (live)", "active_substance": "Chikungunya virus, strain CHIKV LR2006-OPY1, live attenuated", "therapeutic_area_mesh": "Chikungunya virus", "species_veterinary": "", "patient_safety": "Yes", "atc_code_human": "J07BP01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ixchiq is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals between 12 years older. The use of this vaccine should be in accordance with official recommendations. ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Valneva Austria GmbH", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/06/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "31/05/2024", "last_updated_date": "18/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ixchiq" }, { "category": "Human", "name_of_medicine": "Paxlovid", "ema_product_number": "EMEA/H/C/005973", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310898", "international_non_proprietary_name_common_name": "nirmatrelvir;ritonavir", "active_substance": "nirmatrelvir;ritonavir", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE30", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Paxlovid is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and paediatric patients 6 years of age and older weighing at least 20 kg who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID 19 (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "16/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/01/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/01/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "28/01/2022", "last_updated_date": "18/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/paxlovid" }, { "category": "Human", "name_of_medicine": "Besponsa", "ema_product_number": "EMEA/H/C/004119", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000257310", "international_non_proprietary_name_common_name": "inotuzumab ozogamicin", "active_substance": "Inotuzumab ozogamicin", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult pPatients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). Besponsa is indicated as monotherapy for paediatric patients 1 year and older with CD22-positive B cell precursor ALL: in first relapse after allo-haematopoietic stem cell transplant (HSCT); after any first relapse in patients with Very High Risk (VHR) disease (see section 5.1); after a second or greater relapse; and in those with refractory disease. Patients with Philadelphia chromosome positive (Ph+) disease should have exhausted relevant BCR-ABL targeting treatment options. ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "06/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/04/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/06/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "05/12/2017", "last_updated_date": "18/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/besponsa" }, { "category": "Human", "name_of_medicine": "Zercepac", "ema_product_number": "EMEA/H/C/005209", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316200", "international_non_proprietary_name_common_name": "trastuzumab", "active_substance": "trastuzumab", "therapeutic_area_mesh": "Breast Neoplasms;Stomach Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Metastatic breast cancer Zercepac is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Zercepac is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC). following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. Zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Zercepac should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/05/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/07/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "28/07/2020", "last_updated_date": "18/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zercepac" }, { "category": "Human", "name_of_medicine": "Imfinzi", "ema_product_number": "EMEA/H/C/004771", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282058", "international_non_proprietary_name_common_name": "durvalumab", "active_substance": "durvalumab", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC28", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Non-Small Cell Lung Cancer (NSCLC)Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Imfinzi as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1). Imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5.1).Imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations. Small Cell Lung Cancer (SCLC)Imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Biliary Tract Cancer (BTC)Imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (BTC). Hepatocellular Carcinoma (HCC)Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).  Imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Endometrial Cancer Imfinzi in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with: - Imfinzi as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR) - Imfinzi in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). Muscle Invasive Bladder Cancer (MIBC) Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC). Gastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC) Imfinzi in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, is indicated for the treatment of adults with resectable gastric or gastro‑oesophageal junction adenocarcinoma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "30/10/2018", "last_updated_date": "18/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imfinzi" }, { "category": "Human", "name_of_medicine": "Usrenty", "ema_product_number": "EMEA/H/C/006794", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325350", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Plaque psoriasis Usrenty is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A). Paediatric plaque psoriasis Usrenty is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Usrenty, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.   Crohn’s Disease Usrenty is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "07/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "25/07/2025", "last_updated_date": "18/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/usrenty" }, { "category": "Human", "name_of_medicine": "Sapropterin Dipharma", "ema_product_number": "EMEA/H/C/005646", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000347620", "international_non_proprietary_name_common_name": "sapropterin", "active_substance": "sapropterin dihydrochloride", "therapeutic_area_mesh": "Phenylketonurias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sapropterin Dipharma is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment. Sapropterin Dipharma is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dipharma Arzneimittel GmbH", "european_commission_decision_date": "13/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/02/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "14/12/2021", "last_updated_date": "18/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sapropterin-dipharma" }, { "category": "Human", "name_of_medicine": "Imvanex", "ema_product_number": "EMEA/H/C/002596", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316261", "international_non_proprietary_name_common_name": "smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)", "active_substance": "modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus", "therapeutic_area_mesh": "Smallpox Vaccine;Monkeypox virus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other viral vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in individuals 12 years of age and older (see sections 4.4 and 5.1).The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bavarian Nordic A/S", "european_commission_decision_date": "26/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/07/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "23/04/2018", "last_updated_date": "18/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imvanex" }, { "category": "Human", "name_of_medicine": "Lucentis", "ema_product_number": "EMEA/H/C/000715", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000344293", "international_non_proprietary_name_common_name": "ranibizumab", "active_substance": "ranibizumab", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications;Myopia, Degenerative;Choroidal Neovascularization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lucentis is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to choroidal neovascularisation (CNV) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "13/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/11/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "48", "first_published_date": "26/07/2018", "last_updated_date": "13/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lucentis" }, { "category": "Human", "name_of_medicine": "Iclusig", "ema_product_number": "EMEA/H/C/002695", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000347793", "international_non_proprietary_name_common_name": "ponatinib", "active_substance": "ponatinib", "therapeutic_area_mesh": "Leukemia, Myeloid;Leukemia, Lymphoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Iclusig is indicated in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1).   See sections 4.2 Assessment of cardiovascular status prior to start of therapy and 4.4 situations where an alternative treatment may be considered.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Incyte Biosciences Distribution B.V.", "european_commission_decision_date": "13/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/07/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "04/06/2018", "last_updated_date": "13/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/iclusig" }, { "category": "Human", "name_of_medicine": "Aspaveli", "ema_product_number": "EMEA/H/C/005553", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000333829", "international_non_proprietary_name_common_name": "pegcetacoplan", "active_substance": "pegcetacoplan", "therapeutic_area_mesh": "Hemoglobinuria, Paroxysmal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AJ03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aspaveli is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. Aspaveli is indicated for the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Swedish Orphan Biovitrum AB (publ)", "european_commission_decision_date": "07/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/12/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "16/12/2021", "last_updated_date": "13/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aspaveli" }, { "category": "Human", "name_of_medicine": "EndolucinBeta", "ema_product_number": "EMEA/H/C/003999", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000341316", "international_non_proprietary_name_common_name": "lutetium (177Lu) chloride", "active_substance": "lutetium (177Lu) chloride", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V10X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Therapeutic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "EndolucinBeta is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ITM Medical Isotopes GmbH", "european_commission_decision_date": "13/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/07/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "27/03/2018", "last_updated_date": "13/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/endolucinbeta" }, { "category": "Human", "name_of_medicine": "Hetronifly", "ema_product_number": "EMEA/H/C/006170", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000284402", "international_non_proprietary_name_common_name": "serplulimab", "active_substance": "serplulimab", "therapeutic_area_mesh": "Small Cell Lung Carcinoma;Carcinoma, Non-Small-Cell Lung;Esophageal Squamous Cell Carcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FF12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Small cell lung cancer (SCLC) Hetronifly in combination with carboplatin and etoposide is indicated for the first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC). Non-small cell lung carcinoma (NSCLC) Hetronifly in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have: locally advanced NSCLC who are not candidates for surgery or radiotherapy, or metastatic NSCLC. Oesophageal squamous cell carcinoma (OSCC) Hetronifly in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "30/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "20/09/2024", "last_updated_date": "13/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hetronifly" }, { "category": "Human", "name_of_medicine": "Rivastigmine Hexal", "ema_product_number": "EMEA/H/C/001182", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000301284", "international_non_proprietary_name_common_name": "rivastigmine", "active_substance": "rivastigmine", "therapeutic_area_mesh": "Dementia;Alzheimer Disease;Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Hexal AG ", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/12/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "08/08/2016", "last_updated_date": "13/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rivastigmine-hexal" }, { "category": "Human", "name_of_medicine": "Sotyktu", "ema_product_number": "EMEA/H/C/005755", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282554", "international_non_proprietary_name_common_name": "deucravacitinib", "active_substance": "deucravacitinib", "therapeutic_area_mesh": "Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AF07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Plaque psoriasis Sotyktu is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Sotyktu, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "30/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/01/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/03/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "24/01/2023", "last_updated_date": "12/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sotyktu" }, { "category": "Human", "name_of_medicine": "Ezmekly", "ema_product_number": "EMEA/H/C/006460", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000334329", "international_non_proprietary_name_common_name": "mirdametinib", "active_substance": "mirdametinib", "therapeutic_area_mesh": "Neurofibromatosis 1;Neurofibroma, Plexiform", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Europe B.V. ", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/07/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "23/05/2025", "last_updated_date": "12/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ezmekly" }, { "category": "Human", "name_of_medicine": "Xbonzy", "ema_product_number": "EMEA/H/C/006722", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000341436", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Giant Cell Tumor of Bone;Neoplasms, Bone Tissue", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Reddy Holding GmbH", "european_commission_decision_date": "11/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "19/09/2025", "last_updated_date": "12/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xbonzy" }, { "category": "Human", "name_of_medicine": "Evrenzo", "ema_product_number": "EMEA/H/C/004871", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000347565", "international_non_proprietary_name_common_name": "roxadustat", "active_substance": "roxadustat", "therapeutic_area_mesh": "Anemia;Kidney Failure, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma Europe B.V.", "european_commission_decision_date": "11/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/06/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "24/08/2021", "last_updated_date": "12/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evrenzo" }, { "category": "Human", "name_of_medicine": "Olazax Disperzi", "ema_product_number": "EMEA/H/C/001088", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000343978", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Glenmark Pharmaceuticals s.r.o. ", "european_commission_decision_date": "11/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/12/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "23/02/2017", "last_updated_date": "12/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/olazax-disperzi" }, { "category": "Human", "name_of_medicine": "Zoledronic acid Actavis", "ema_product_number": "EMEA/H/C/002488", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG1612", "international_non_proprietary_name_common_name": "zoledronic acid", "active_substance": "zoledronic acid monohydrate", "therapeutic_area_mesh": "Fractures, Bone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "31/05/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/02/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/04/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/03/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "03/10/2017", "last_updated_date": "12/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zoledronic-acid-actavis" }, { "category": "Human", "name_of_medicine": "Zoledronic Acid Hospira", "ema_product_number": "EMEA/H/C/002365", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0045", "international_non_proprietary_name_common_name": "zoledronic acid", "active_substance": "zoledronic acid monohydrate", "therapeutic_area_mesh": "Hypercalcemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "4 mg / 5 ml and 4 mg / 100 ml: Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH). 5 mg / 100 ml: Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: in post-menopausal women; in men; at increased risk of fracture. Treatment of Paget's disease of the bone in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "01/10/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/02/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "12/02/2018", "last_updated_date": "12/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zoledronic-acid-hospira" }, { "category": "Veterinary", "name_of_medicine": "Emepax", "ema_product_number": "EMEA/V/C/006655", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "maropitant", "active_substance": "maropitant", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Alimentary tract and metabolism;Other antiemetics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/02/2026", "last_updated_date": "12/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/emepax" }, { "category": "Human", "name_of_medicine": "Xolremdi", "ema_product_number": "EMEA/H/C/006496", "medicine_status": "Authorised", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "mavorixafor", "active_substance": "mavorixafor", "therapeutic_area_mesh": "Primary Immunodeficiency Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AX24", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xolremdi is indicated in patients 12 years of age and older for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "X4 Pharmaceuticals GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/04/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "12/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xolremdi" }, { "category": "Veterinary", "name_of_medicine": "AviGate S. Infantis", "ema_product_number": "EMEA/V/C/006646", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Salmonella Infantis vaccine (live)", "active_substance": "salmonella enterica, subsp. enterica, serovar Infantis, strain J-6-24 ΔcpxRA Δlon1, Live", "therapeutic_area_mesh": "", "species_veterinary": "Chicken", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Live bacterial vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/03/2026", "last_updated_date": "12/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/avigate-s-infantis" }, { "category": "Veterinary", "name_of_medicine": "VeroBlue-3", "ema_product_number": "EMEA/V/C/006821", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bluetongue virus vaccine (inactivated)", "active_substance": "bluetongue virus, serotype 3, VP2 protein", "therapeutic_area_mesh": "", "species_veterinary": "Sheep", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Ovidae;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/03/2026", "last_updated_date": "12/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/veroblue-3" }, { "category": "Human", "name_of_medicine": "Lenalidomide Mylan", "ema_product_number": "EMEA/H/C/005306", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000334301", "international_non_proprietary_name_common_name": "lenalidomide", "active_substance": "lenalidomide", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Multiple myeloma Lenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphoma Lenalidomide Mylan in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1-3a).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "11/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/10/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/12/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "07/01/2021", "last_updated_date": "11/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-mylan" }, { "category": "Human", "name_of_medicine": "Olazax", "ema_product_number": "EMEA/H/C/001087", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000343977", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Glenmark Pharmaceuticals s.r.o. ", "european_commission_decision_date": "11/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/12/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "23/02/2017", "last_updated_date": "11/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/olazax" }, { "category": "Human", "name_of_medicine": "Tobi Podhaler", "ema_product_number": "EMEA/H/C/002155", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "tobramycin", "active_substance": "tobramycin", "therapeutic_area_mesh": "Cystic Fibrosis;Respiratory Tract Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01GB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Healthcare Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/07/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "23/04/2018", "last_updated_date": "11/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tobi-podhaler" }, { "category": "Human", "name_of_medicine": "Imuldosa", "ema_product_number": "EMEA/H/C/006221", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000341697", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Crohn Disease;Psoriasis;Arthritis, Psoriatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adult Crohn’s Disease Imuldosa is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Paediatric Crohn’s Disease Imuldosa is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Plaque psoriasis Imuldosa is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A). Paediatric plaque psoriasis Imuldosa is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Imuldosa, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease- modifying anti-rheumatic drug (DMARD) therapy has been inadequate.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "11/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/12/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "18/10/2024", "last_updated_date": "11/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imuldosa" }, { "category": "Human", "name_of_medicine": "Omlyclo", "ema_product_number": "EMEA/H/C/005958", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315350", "international_non_proprietary_name_common_name": "omalizumab", "active_substance": "omalizumab", "therapeutic_area_mesh": "Asthma;Urticaria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03DX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Allergic asthma Omlyclo is indicated in adults, adolescents and children (6 to <12 years of age).  Omlyclo treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2). Adults and adolescents (12 years of age and older) Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Children (6 to <12 years of age) Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Chronic rhinosinusitis with nasal polyps (CRSwNP) Omlyclo is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control. Chronic spontaneous urticaria (CSU) Omlyclo is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "19/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/05/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "22/03/2024", "last_updated_date": "11/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/omlyclo" }, { "category": "Human", "name_of_medicine": "Exdensur", "ema_product_number": "EMEA/H/C/006446", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000340523", "international_non_proprietary_name_common_name": "depemokimab", "active_substance": "depemokimab", "therapeutic_area_mesh": "Asthma;Nasal Polyps", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03DX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Asthma  Exdensur is indicated as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller (see section 5.1). Chronic rhinosinusitis with nasal polyps (CRSwNP)  Exdensur is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "08/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/12/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/02/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "12/12/2025", "last_updated_date": "11/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exdensur" }, { "category": "Human", "name_of_medicine": "Qalsody", "ema_product_number": "EMEA/H/C/005493", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296462", "international_non_proprietary_name_common_name": "tofersen", "active_substance": "tofersen", "therapeutic_area_mesh": "Amyotrophic Lateral Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Qalsody is indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biogen Netherlands B.V. ", "european_commission_decision_date": "12/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/05/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "14/06/2024", "last_updated_date": "11/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qalsody" }, { "category": "Human", "name_of_medicine": "Amglidia", "ema_product_number": "EMEA/H/C/004379", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0017", "international_non_proprietary_name_common_name": "glibenclamide", "active_substance": "glibenclamide", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children. Sulphonylureas like Amglidia have been shown to be effective in patients with mutations in the genes coding for the ?-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ammtek", "european_commission_decision_date": "05/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/05/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "31/07/2018", "last_updated_date": "11/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amglidia" }, { "category": "Human", "name_of_medicine": "Giotrif", "ema_product_number": "EMEA/H/C/002280", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000326537", "international_non_proprietary_name_common_name": "afatinib", "active_substance": "afatinib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Giotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "08/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "28/06/2018", "last_updated_date": "11/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/giotrif" }, { "category": "Human", "name_of_medicine": "Orencia", "ema_product_number": "EMEA/H/C/000701", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000287898", "international_non_proprietary_name_common_name": "abatacept", "active_substance": "abatacept", "therapeutic_area_mesh": "Arthritis, Psoriatic;Arthritis, Juvenile Rheumatoid;Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA24", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritisOrencia, in combination with methotrexate, is indicated for: the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate. A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate. Psoriatic arthritis Orencia, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required.  Polyarticular juvenile idiopathic arthritis Orencia in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 2 years of age and older who have had an inadequate response to previous DMARD therapy. Orencia can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/03/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/05/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "43", "first_published_date": "25/07/2017", "last_updated_date": "11/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orencia" }, { "category": "Human", "name_of_medicine": "Denbrayce", "ema_product_number": "EMEA/H/C/006199", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000343113", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Neoplasms, Bone Tissue;Giant Cell Tumor of Bone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mabxience Research SL", "european_commission_decision_date": "08/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "25/04/2025", "last_updated_date": "11/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/denbrayce" }, { "category": "Human", "name_of_medicine": "Ojemda", "ema_product_number": "EMEA/H/C/006140", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tovorafenib", "active_substance": "tovorafenib", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (for biomarkers-based patient selection, see section 4.2)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ipsen Pharma", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/04/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "11/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ojemda" }, { "category": "Human", "name_of_medicine": "Olanzapine Glenmark Europe", "ema_product_number": "EMEA/H/C/001086", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000343549", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Glenmark Arzneimittel GmbH", "european_commission_decision_date": "07/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/12/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "23/10/2017", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/olanzapine-glenmark-europe" }, { "category": "Human", "name_of_medicine": "Olanzapine Glenmark", "ema_product_number": "EMEA/H/C/001085", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000343477", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Glenmark Arzneimittel GmbH", "european_commission_decision_date": "07/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/12/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "23/02/2017", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/olanzapine-glenmark" }, { "category": "Human", "name_of_medicine": "Elebrato Ellipta", "ema_product_number": "EMEA/H/C/004781", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000347292", "international_non_proprietary_name_common_name": "fluticasone furoate;umeclidinium;vilanterol", "active_substance": "fluticasone furoate;umeclidinium bromide;vilanterol trifenatate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Elebrato Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting ?2-agonist.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "07/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "30/05/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elebrato-ellipta" }, { "category": "Human", "name_of_medicine": "Trelegy Ellipta", "ema_product_number": "EMEA/H/C/004363", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000347286", "international_non_proprietary_name_common_name": "fluticasone furoate;umeclidinium;vilanterol", "active_substance": "fluticasone furoate;umeclidinium bromide;vilanterol trifenatate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trelegy Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting ?2-agonist.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "07/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "30/05/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trelegy-ellipta" }, { "category": "Human", "name_of_medicine": "Remsima", "ema_product_number": "EMEA/H/C/002576", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315906", "international_non_proprietary_name_common_name": "infliximab", "active_substance": "infliximab", "therapeutic_area_mesh": "Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Psoriasis;Crohn Disease;Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease?modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X?ray, has been demonstrated. Adult Crohn’s disease Remsima is indicated for: treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant or who are intolerant to or have medical contraindications for such therapies; treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric Crohn’s disease Remsima is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged six to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy. Ulcerative colitis Remsima is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6?mercaptopurine (6?MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Remsima is indicated for treatment of severely active ulcerative colitis in children and adolescents aged six to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6?MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Ankylosing spondylitis Remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy. Psoriatic arthritis Remsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Remsima should be administered: in combination with methotrexate; or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X?ray in patients with polyarticular symmetrical subtypes of the disease. Psoriasis Remsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "19/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "48", "first_published_date": "21/06/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/remsima" }, { "category": "Human", "name_of_medicine": "Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)", "ema_product_number": "EMEA/H/C/003963", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000313191", "international_non_proprietary_name_common_name": "pandemic influenza vaccine (H5N1) (live attenuated, nasal)", "active_substance": "reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age. Pandemic influenza vaccine H5N1 AstraZeneca should be used in accordance with official guidance", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/03/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/05/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "23/06/2017", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pandemic-influenza-vaccine-h5n1-astrazeneca" }, { "category": "Human", "name_of_medicine": "Genvoya", "ema_product_number": "EMEA/H/C/004042", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "X/0079/G", "international_non_proprietary_name_common_name": "elvitegravir;cobicistat;emtricitabine;tenofovir alafenamide", "active_substance": "elvitegravir;cobicistat;emtricitabine;tenofovir alafenamide", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Genvoya is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (HIV 1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "03/10/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "26/07/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/genvoya" }, { "category": "Human", "name_of_medicine": "Ixiaro", "ema_product_number": "EMEA/H/C/000963", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000302084", "international_non_proprietary_name_common_name": "Japanese encephalitis vaccine (inactivated, adsorbed)", "active_substance": "Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)", "therapeutic_area_mesh": "Encephalitis, Japanese;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ixiaro is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants aged two months and older. Ixiaro should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Valneva Austria GmbH", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/03/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "08/01/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ixiaro" }, { "category": "Human", "name_of_medicine": "Gardasil 9", "ema_product_number": "EMEA/H/C/003852", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000303460", "international_non_proprietary_name_common_name": "human papillomavirus 9-valent vaccine (recombinant, adsorbed)", "active_substance": "human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed)", "therapeutic_area_mesh": "Condylomata Acuminata;Papillomavirus Infections;Immunization;Uterine Cervical Dysplasia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BM03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Papillomavirus vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases: Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types Genital warts (Condyloma acuminata) caused by specific HPV types. See sections 4.4 and 5.1 for important information on the data that support these indications. The use of Gardasil 9 should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "09/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/03/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/06/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "26/07/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gardasil-9" }, { "category": "Human", "name_of_medicine": "Loargys", "ema_product_number": "EMEA/H/C/005484", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000312501", "international_non_proprietary_name_common_name": "pegzilarginase", "active_substance": "Pegzilarginase", "therapeutic_area_mesh": "Hyperargininemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB24", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Loargys is indicated for the treatment of arginase 1 deficiency (ARG1 D), also known as hyperargininemia, in adults, adolescents and children aged 2 years and older.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Immedica Pharma AB", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/10/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/12/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "13/10/2023", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/loargys" }, { "category": "Human", "name_of_medicine": "Esbriet", "ema_product_number": "EMEA/H/C/002154", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000338756", "international_non_proprietary_name_common_name": "pirfenidone", "active_substance": "Pirfenidone", "therapeutic_area_mesh": "Idiopathic Pulmonary Fibrosis;Lung Diseases;Respiratory Tract Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "H.A.C. Pharma", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/02/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "17/04/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/esbriet" }, { "category": "Human", "name_of_medicine": "Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan)", "ema_product_number": "EMEA/H/C/004049", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "tenofovir disoproxil", "active_substance": "tenofovir disoproxil", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "HIV-1 infection Tenofovir disoproxil 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults. In adults, the demonstration of the benefit of tenofovir disoproxil in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml). Tenofovir disoproxil 245 mg film-coated tablets are also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. The choice of tenofovir disoproxil to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. evidence of lamivudine-resistant hepatitis B virus. decompensated liver disease. Tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with: compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/12/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "27/11/2017", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tenofovir-disoproxil-viatris" }, { "category": "Human", "name_of_medicine": "Bimzelx", "ema_product_number": "EMEA/H/C/005316", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000304244", "international_non_proprietary_name_common_name": "bimekizumab", "active_substance": "bimekizumab", "therapeutic_area_mesh": "Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "bimekizumab ", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Plaque psoriasis Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Bimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. Hidradenitis suppurativa (HS)Bimzelx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma S.A.  ", "european_commission_decision_date": "30/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/06/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/08/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "24/08/2021", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bimzelx" }, { "category": "Human", "name_of_medicine": "Teduglutide Viatris", "ema_product_number": "EMEA/H/C/006564", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "teduglutide", "active_substance": "teduglutide", "therapeutic_area_mesh": "Short Bowel Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Teduglutide Viatris is indicated for the treatment of patients 4 months corrected gestational age and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "14/11/2025", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/teduglutide-viatris" }, { "category": "Human", "name_of_medicine": "Bylvay", "ema_product_number": "EMEA/H/C/004691", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000306638", "international_non_proprietary_name_common_name": "odevixibat", "active_substance": "odevixibat", "therapeutic_area_mesh": "Cholestasis, Intrahepatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A05AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bile and liver therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Ipsen Pharma", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/07/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "20/04/2021", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bylvay" }, { "category": "Human", "name_of_medicine": "Strimvelis", "ema_product_number": "EMEA/H/C/003854", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282063", "international_non_proprietary_name_common_name": "autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence", "active_substance": "autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells", "therapeutic_area_mesh": "Severe Combined Immunodeficiency", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Strimvelis is indicated for the treatment of patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID), for whom no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available (see section 4.2 and section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fondazione Telethon ETS", "european_commission_decision_date": "30/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/03/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "23/08/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/strimvelis" }, { "category": "Human", "name_of_medicine": "Latuda", "ema_product_number": "EMEA/H/C/002713", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000341353", "international_non_proprietary_name_common_name": "lurasidone", "active_substance": "lurasidone", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AE05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of schizophrenia in adults aged 18 years and over.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Aziende Chimiche Riunite Angelini Francesco S.p.A.", "european_commission_decision_date": "06/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/01/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "12/03/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/latuda" }, { "category": "Human", "name_of_medicine": "Talmanco (previously Tadalafil Generics)", "ema_product_number": "EMEA/H/C/004297", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "tadalafil", "active_substance": "tadalafil", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "04/06/2017", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/talmanco" }, { "category": "Human", "name_of_medicine": "Rivaroxaban Viatris (previously Rivaroxaban Mylan)", "ema_product_number": "EMEA/H/C/005600", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "rivaroxaban", "active_substance": "rivaroxaban", "therapeutic_area_mesh": "Venous Thromboembolism;Pulmonary Embolism;Acute Coronary Syndrome;Stroke;Coronary Artery Disease;Peripheral Arterial Disease;Atrial Fibrillation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AF01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.  Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.  ------ Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.  Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. ------- Adults  Prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Paediatric population  Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Paediatric population  Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/11/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "14/09/2021", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rivaroxaban-viatris" }, { "category": "Human", "name_of_medicine": "Ritonavir Viatris (previously Ritonavir Mylan)", "ema_product_number": "EMEA/H/C/004549", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "ritonavir", "active_substance": "ritonavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV 1 infected patients (adults and children of 2 years of age and older).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "03/05/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ritonavir-viatris" }, { "category": "Human", "name_of_medicine": "Itovebi", "ema_product_number": "EMEA/H/C/006353", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000309145", "international_non_proprietary_name_common_name": "inavolisib", "active_substance": "inavolisib", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment (see section 5.1). Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence. In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH ", "european_commission_decision_date": "30/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/07/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "23/05/2025", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/itovebi" }, { "category": "Human", "name_of_medicine": "Pregabalin Viatris (previously Pregabalin Mylan)", "ema_product_number": "EMEA/H/C/004078", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "pregabalin", "active_substance": "pregabalin", "therapeutic_area_mesh": "Anxiety Disorders;Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02BF02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Neuropathic pain Pregabalin Viatris is indicated for the treatment of peripheral and central neuropathic pain in adults. EpilepsyPregabalin Viatris is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety DisorderPregabalin Viatris is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/06/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "04/06/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pregabalin-viatris" }, { "category": "Human", "name_of_medicine": "Pomalidomide Viatris", "ema_product_number": "EMEA/H/C/006195", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "pomalidomide", "active_substance": "Pomalidomide", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pomalidomide Viatris in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.Pomalidomide Viatris in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/02/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "15/12/2023", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-viatris" }, { "category": "Human", "name_of_medicine": "Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris", "ema_product_number": "EMEA/H/C/006491", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "emtricitabine;rilpivirine;tenofovir alafenamide", "active_substance": "emtricitabine;rilpivirine hydrochloride;tenofovir alafenamide fumarate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR19", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤ 100 000 HIV 1 RNA copies/mL (see sections 4.2, 4.4 and 5.1). ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/06/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "20/06/2025", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabine-rilpivirine-tenofovir-alafenamide-viatris" }, { "category": "Human", "name_of_medicine": "Mayzent", "ema_product_number": "EMEA/H/C/004712", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000339988", "international_non_proprietary_name_common_name": "siponimod", "active_substance": "siponimod fumaric acid", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Selective immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "06/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/01/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "23/01/2020", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mayzent" }, { "category": "Human", "name_of_medicine": "Nintedanib Viatris", "ema_product_number": "EMEA/H/C/006486", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "nintedanib", "active_substance": "nintedanib", "therapeutic_area_mesh": "Idiopathic Pulmonary Fibrosis;Lung Diseases, Interstitial;Pulmonary Fibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Viatris is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Viatris is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs). Nintedanib Viatris is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/06/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "20/06/2025", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nintedanib-viatris" }, { "category": "Human", "name_of_medicine": "Kanjinti", "ema_product_number": "EMEA/H/C/004361", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000268786", "international_non_proprietary_name_common_name": "trastuzumab", "active_substance": "trastuzumab", "therapeutic_area_mesh": "Stomach Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Metastatic breast cancer Kanjinti is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone-receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Kanjinti is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC): following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant KANJINTI therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. Kanjinti should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Kanjinti in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Kanjinti should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC 2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "13/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/03/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/05/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "17/08/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kanjinti" }, { "category": "Human", "name_of_medicine": "Teizeild", "ema_product_number": "EMEA/H/C/005496", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "teplizumab", "active_substance": "teplizumab", "therapeutic_area_mesh": "Diabetes Mellitus, Type 1", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10XX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Teizeild is indicated to delay the onset of stage 3 type 1 diabetes (T1D) in adult and paediatric patients 8 years of age and older with stage 2 T1D.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "08/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "14/11/2025", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/teizeild" }, { "category": "Human", "name_of_medicine": "Dupixent", "ema_product_number": "EMEA/H/C/004390", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000324876", "international_non_proprietary_name_common_name": "dupilumab", "active_substance": "dupilumab", "therapeutic_area_mesh": "Dermatitis, Atopic;Prurigo;Esophageal Diseases;Asthma;Sinusitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D11AH05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents for dermatitis, excluding corticosteroids", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Atopic dermatitis Adults and adolescents Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Children 6 months to 11 years of age Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. Asthma Adults and adolescents Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Children 6 to 11 years of age Dupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Chronic rhinosinusitis with nasal polyposis (CRSwNP) Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. Prurigo Nodularis (PN) Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy. Eosinophilic esophagitis (EoE) Dupixent is indicated for the treatment of eosinophilic esophagitis in adults, adolescents and children aged 1 year and older, weighing at least 15 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. Chronic obstructive pulmonary disease (COPD) Dupixent is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Chronic Spontaneous Urticaria (CSU) Dupixent is indicated for the treatment of moderate to severe chronic spontaneous urticaria in adults, adolescents and children (2 years and above) patients with inadequate response to H1 antihistamines and who are naive to anti-IgE therapy for CSU.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/09/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "48", "first_published_date": "16/01/2018", "last_updated_date": "08/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dupixent" }, { "category": "Human", "name_of_medicine": "Mysildecard", "ema_product_number": "EMEA/H/C/004186", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "sildenafil", "active_substance": "sildenafil", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "AdultsTreatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric populationTreatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "15/09/2016", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mysildecard" }, { "category": "Human", "name_of_medicine": "Febuxostat Viatris (previously Febuxostat Mylan)", "ema_product_number": "EMEA/H/C/004374", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "febuxostat", "active_substance": "febuxostat", "therapeutic_area_mesh": "Hyperuricemia;Arthritis, Gouty;Gout", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M04AA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antigout preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Febuxostat Viatris is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Viatris is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).   Febuxostat Viatris is indicated in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/04/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/06/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "15/06/2017", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/febuxostat-viatris" }, { "category": "Human", "name_of_medicine": "Entecavir Viatris (previously Entecavir Mylan)", "ema_product_number": "EMEA/H/C/004377", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "entecavir", "active_substance": "entecavir monohydrate", "therapeutic_area_mesh": "Hepatitis B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Entecavir Viatris is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. decompensated liver disease. For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.Entecavir Viatris is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/05/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "18/09/2017", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/entecavir-viatris" }, { "category": "Human", "name_of_medicine": "Eltrombopag Viatris", "ema_product_number": "EMEA/H/C/006417", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "eltrombopag", "active_substance": "eltrombopag olamine", "therapeutic_area_mesh": "Purpura, Thrombocytopenic, Idiopathic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eltrombopag Viatris is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Eltrombopag Viatris is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).Eltrombopag Viatris is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.2 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/12/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "18/10/2024", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eltrombopag-viatris" }, { "category": "Human", "name_of_medicine": "Duloxetine Viatris (previously Duloxetine Mylan)", "ema_product_number": "EMEA/H/C/003981", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "duloxetine", "active_substance": "duloxetine", "therapeutic_area_mesh": "Neuralgia;Diabetic Neuropathies;Depressive Disorder, Major;Anxiety Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder Duloxetine Viatris is indicated in adults", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/06/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "03/08/2018", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duloxetine-viatris" }, { "category": "Human", "name_of_medicine": "Darunavir Viatris (previously Darunavir Mylan)", "ema_product_number": "EMEA/H/C/004068", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "darunavir", "active_substance": "darunavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection (see section 4.2). Darunavir Viatris 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2): For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated. For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1). Darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.  Darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2).  Darunavir Viatris 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:  antiretroviral therapy (ART)-naïve (see section 4.2).  ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ? 100 cells x 10?/L. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/01/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "12/07/2018", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/darunavir-viatris" }, { "category": "Human", "name_of_medicine": "Ibandronic Acid Sandoz", "ema_product_number": "EMEA/H/C/002367", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0021", "international_non_proprietary_name_common_name": "ibandronic acid", "active_substance": "ibandronic acid", "therapeutic_area_mesh": "Breast Neoplasms;Neoplasm Metastasis;Fractures, Bone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases;Bisphosphonates", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "06/07/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/02/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/01/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "21/07/2016", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ibandronic-acid-sandoz" }, { "category": "Human", "name_of_medicine": "Dapagliflozin Viatris", "ema_product_number": "EMEA/H/C/006006", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "dapagliflozin", "active_substance": "dapagliflozin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2;Heart Failure, Systolic;Heart Failure;Renal Insufficiency, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BK01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Type 2 diabetes mellitus Dapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Dapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. Chronic kidney disease Dapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/01/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/03/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "24/01/2023", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dapagliflozin-viatris" }, { "category": "Human", "name_of_medicine": "Cinacalcet Viatris (previously Cinacalcet Mylan)", "ema_product_number": "EMEA/H/C/004014", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "cinacalcet", "active_substance": "cinacalcet hydrochloride", "therapeutic_area_mesh": "Hyperparathyroidism, Secondary;Hypercalcemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05BX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate. Reduction of hypercalcaemia in patients with: parathyroid carcinoma primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "11/01/2017", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cinacalcet-viatris" }, { "category": "Human", "name_of_medicine": "Rapilysin", "ema_product_number": "EMEA/H/C/000105", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG1612", "international_non_proprietary_name_common_name": "reteplase", "active_substance": "reteplase", "therapeutic_area_mesh": "Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (AMI) symptoms.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "31/05/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/08/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "26/01/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "21/08/2018", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rapilysin" }, { "category": "Human", "name_of_medicine": "Afiveg", "ema_product_number": "EMEA/H/C/006761", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000340400", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications;Retinal Vein Occlusion;Choroidal Neovascularization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Afiveg is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual impairment due to diabetic macular oedema (DME) (see section1), visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "STADA Arzneimittel AG", "european_commission_decision_date": "06/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/06/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "20/06/2025", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/afiveg" }, { "category": "Human", "name_of_medicine": "Ambrisentan Viatris (previously Ambrisentan Mylan)", "ema_product_number": "EMEA/H/C/004985", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "ambrisentan", "active_substance": "ambrisentan", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "15/07/2019", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ambrisentan-viatris" }, { "category": "Human", "name_of_medicine": "Loqtorzi", "ema_product_number": "EMEA/H/C/006120", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000341695", "international_non_proprietary_name_common_name": "toripalimab", "active_substance": "toripalimab", "therapeutic_area_mesh": "Nasopharyngeal Carcinoma;Esophageal Squamous Cell Carcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FF13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma. Loqtorzi, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Topalliance Biosciences Europe Limited", "european_commission_decision_date": "06/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "26/07/2024", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/loqtorzi" }, { "category": "Human", "name_of_medicine": "Humira", "ema_product_number": "EMEA/H/C/000481", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000287800", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Spondylitis, Ankylosing;Arthritis, Juvenile Rheumatoid;Uveitis;Colitis, Ulcerative;Psoriasis;Arthritis, Psoriatic;Crohn Disease;Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Please refer to the product information document.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "08/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/09/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "97", "first_published_date": "26/07/2018", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/humira" }, { "category": "Human", "name_of_medicine": "Atazanavir Viatris (previously Atazanavir Mylan)", "ema_product_number": "EMEA/H/C/004048", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "atazanavir", "active_substance": "atazanavir (as sulfate)", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Atazanavir Viatris, co-administered with low dose ritonavir, is indicated for the treatment of HIV 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations). There are very limited data available from children aged 6 to less than 18 years. The choice of Atazanavir  Viatrisin treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "03/05/2018", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/atazanavir-viatris" }, { "category": "Human", "name_of_medicine": "Ilumetri", "ema_product_number": "EMEA/H/C/004514", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000261769", "international_non_proprietary_name_common_name": "tildrakizumab", "active_substance": "tildrakizumab", "therapeutic_area_mesh": "Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants;Interleukin inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Almirall, S.A.", "european_commission_decision_date": "05/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "27/07/2018", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ilumetri" }, { "category": "Human", "name_of_medicine": "Comtan", "ema_product_number": "EMEA/H/C/000171", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325887", "international_non_proprietary_name_common_name": "entacapone", "active_substance": "entacapone", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Orion Corporation", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/09/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "27/06/2018", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/comtan" }, { "category": "Human", "name_of_medicine": "Arixtra", "ema_product_number": "EMEA/H/C/000403", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325156", "international_non_proprietary_name_common_name": "fondaparinux sodium", "active_substance": "fondaparinux sodium", "therapeutic_area_mesh": "Venous Thrombosis;Pulmonary Embolism;Myocardial Infarction;Angina, Unstable", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injection Prevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. Prevention of VTE in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery. Prevention of VTE in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and / or acute respiratory disorders, and / or acute infectious or inflammatory disease. Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis. 2.5-mg/0.5-ml solution for injection Treatment of unstable angina or non-ST-segment-elevation myocardial infarction (UA/NSTEMI) in adult patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated. infarction (STEMI) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. 5-mg/0.4-ml, 7.5-mg/0.6-ml and 10-mg/0.8-ml solution for injection Treatment of adults with acute deep-vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Healthcare Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/07/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/03/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "21/03/2018", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/arixtra" }, { "category": "Human", "name_of_medicine": "Fintepla", "ema_product_number": "EMEA/H/C/003933", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000296555", "international_non_proprietary_name_common_name": "fenfluramine", "active_substance": "fenfluramine hydrochloride", "therapeutic_area_mesh": "Epilepsies, Myoclonic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of seizures associated with Dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older. Fintepla is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma S.A.  ", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/10/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/12/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "08/01/2021", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fintepla" }, { "category": "Human", "name_of_medicine": "Uzpruvo", "ema_product_number": "EMEA/H/C/006101", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000335760", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Psoriasis;Arthritis, Psoriatic;Crohn Disease;Colitis, Ulcerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Plaque psoriasisUzpruvo is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A).Paediatric plaque psoriasisUzpruvo is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.Psoriatic arthritis (PsA)Uzpruvo, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.Adult Crohn’s DiseaseUzpruvo is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Paediatric Crohn's DiseaseUzpruvo is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stada Arzneimittel AG", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/01/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "10/11/2023", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/uzpruvo" }, { "category": "Human", "name_of_medicine": "Dimethyl fumarate Mylan", "ema_product_number": "EMEA/H/C/006397", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000335043", "international_non_proprietary_name_common_name": "dimethyl fumarate", "active_substance": "dimethyl fumarate", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dimethyl fumarate Mylan is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "11/07/2024", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-mylan" }, { "category": "Human", "name_of_medicine": "Beovu", "ema_product_number": "EMEA/H/C/004913", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000343868", "international_non_proprietary_name_common_name": "brolucizumab", "active_substance": "brolucizumab", "therapeutic_area_mesh": "Wet Macular Degeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (AMD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "05/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/02/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "18/02/2020", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/beovu" }, { "category": "Human", "name_of_medicine": "Truvelog Mix 30", "ema_product_number": "EMEA/H/C/005635", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0004", "international_non_proprietary_name_common_name": "insulin aspart", "active_substance": "insulin aspart", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AD05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Truvelog Mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "06/07/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/04/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "25/01/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "23/02/2022", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/truvelog-mix-30" }, { "category": "Human", "name_of_medicine": "CellCept", "ema_product_number": "EMEA/H/C/000082", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000296546", "international_non_proprietary_name_common_name": "mycophenolate mofetil", "active_substance": "mycophenolate mofetil", "therapeutic_area_mesh": "Graft Rejection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult and paediatric (1 to 18 years of age) patients receiving allogeneic renal, cardiac or hepatic transplants.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "42", "first_published_date": "09/08/2018", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cellcept" }, { "category": "Human", "name_of_medicine": "Olumiant", "ema_product_number": "EMEA/H/C/004085", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "X/0000257923", "international_non_proprietary_name_common_name": "baricitinib", "active_substance": "baricitinib", "therapeutic_area_mesh": "Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA37", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate. Atopic Dermatitis Olumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. Alopecia areata Baricitinib is indicated for the treatment of severe alopecia areata in adult and adolescent patients 12 years of age and older.  Juvenile idiopathic arthritis Baricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs: Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), Enthesitis related arthritis, and Juvenile psoriatic arthritis. Baricitinib may be used as monotherapy or in combination with methotrexate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "27/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/02/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "25/01/2018", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/olumiant" }, { "category": "Human", "name_of_medicine": "Kerendia", "ema_product_number": "EMEA/H/C/005200", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "X/0000248026", "international_non_proprietary_name_common_name": "finerenone", "active_substance": "finerenone", "therapeutic_area_mesh": "Renal Insufficiency, Chronic;Diabetes Mellitus, Type 2;Heart Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kerendia is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults. For study results with respect to renal and cardiovascular events, see section 5.1. Kerendia is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/02/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "14/12/2021", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kerendia" }, { "category": "Human", "name_of_medicine": "Dovprela (previously Pretomanid FGK)", "ema_product_number": "EMEA/H/C/005167", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000343394", "international_non_proprietary_name_common_name": "pretomanid", "active_substance": "pretomanid", "therapeutic_area_mesh": "Tuberculosis, Multidrug-Resistant", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycobacterials", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan IRE Healthcare Limited", "european_commission_decision_date": "04/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/07/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "11/08/2020", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dovprela" }, { "category": "Human", "name_of_medicine": "Oncaspar", "ema_product_number": "EMEA/H/C/003789", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000344088", "international_non_proprietary_name_common_name": "pegaspargase", "active_substance": "pegaspargase", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX24", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "04/05/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/01/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "27/03/2018", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/oncaspar" }, { "category": "Human", "name_of_medicine": "Usgena", "ema_product_number": "EMEA/H/C/006667", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000338332", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Crohn Disease;Psoriasis;Arthritis, Psoriatic;Colitis, Ulcerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Crohn’s Disease Usgena is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Ulcerative colitis Usgena is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. Plaque psoriasis Usgena is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1). Paediatric plaque psoriasis Usgena is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1). Psoriatic arthritis (PsA) Usgena, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stada Arzneimittel AG", "european_commission_decision_date": "31/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "19/09/2025", "last_updated_date": "07/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/usgena" }, { "category": "Human", "name_of_medicine": "Tolucombi", "ema_product_number": "EMEA/H/C/002549", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000236862", "international_non_proprietary_name_common_name": "telmisartan;hydrochlorothiazide", "active_substance": "telmisartan;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "telmisartan and diuretics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tolucombi fixed-dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Tolucombi 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "24/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/01/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/03/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "14/02/2018", "last_updated_date": "06/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tolucombi" }, { "category": "Human", "name_of_medicine": "Integrilin", "ema_product_number": "EMEA/H/C/000230", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0088", "international_non_proprietary_name_common_name": "eptifibatide", "active_substance": "eptifibatide", "therapeutic_area_mesh": "Angina, Unstable;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Integrilin is intended for use with acetylsalicylic acid and unfractionated heparin. Integrilin is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and / or elevated cardiac enzymes. Patients most likely to benefit from Integrilin treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early percutaneous transluminal coronary angioplasty (PTCA).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "24/09/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "02/07/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/07/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/01/2026", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "12/04/2017", "last_updated_date": "06/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/integrilin" }, { "category": "Human", "name_of_medicine": "Korjuny", "ema_product_number": "EMEA/H/C/005697", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000304947", "international_non_proprietary_name_common_name": "catumaxomab", "active_substance": "catumaxomab", "therapeutic_area_mesh": "Ascites", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Korjuny is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Atnahs Pharma Netherlands B.V.", "european_commission_decision_date": "19/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "18/10/2024", "last_updated_date": "06/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/korjuny" }, { "category": "Human", "name_of_medicine": "Truqap", "ema_product_number": "EMEA/H/C/006017", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320727", "international_non_proprietary_name_common_name": "capivasertib", "active_substance": "capivasertib", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Truqap is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. In pre- or perimenopausal women, Truqap plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. For men, administration of LHRH agonist according to current clinical practice standards should be considered.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/06/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "11/07/2024", "last_updated_date": "06/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/truqap" }, { "category": "Human", "name_of_medicine": "Ifirmasta (previously Irbesartan Krka)", "ema_product_number": "EMEA/H/C/000962", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000332891", "international_non_proprietary_name_common_name": "irbesartan", "active_substance": "irbesartan hydrochloride", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "30/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/09/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/12/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "05/10/2016", "last_updated_date": "06/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ifirmasta" }, { "category": "Human", "name_of_medicine": "Irbesartan Teva", "ema_product_number": "EMEA/H/C/001093", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000327686", "international_non_proprietary_name_common_name": "irbesartan", "active_substance": "irbesartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "30/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "31/08/2016", "last_updated_date": "06/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/irbesartan-teva" }, { "category": "Human", "name_of_medicine": "Ogsiveo", "ema_product_number": "EMEA/H/C/006071", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000334320", "international_non_proprietary_name_common_name": "nirogacestat", "active_substance": "nirogacestat hydrobromide", "therapeutic_area_mesh": "Desmoid Tumors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX81", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ogsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Europe B.V.", "european_commission_decision_date": "08/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/06/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "20/06/2025", "last_updated_date": "06/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ogsiveo" }, { "category": "Human", "name_of_medicine": "Rhapsido", "ema_product_number": "EMEA/H/C/006313", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "remibrutinib", "active_substance": "remibrutinib", "therapeutic_area_mesh": "Urticaria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA60", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "05/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rhapsido" }, { "category": "Human", "name_of_medicine": "Bimervax", "ema_product_number": "EMEA/H/C/006058", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000312996", "international_non_proprietary_name_common_name": "COVID-19 Vaccine (recombinant, adjuvanted)", "active_substance": "SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion dimer produced by recombinant DNA technology", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BN", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bimervax is indicated as a booster for active immunisation to prevent COVID-19 in individuals 12 years of age and older who have previously received a mRNA COVID-19 vaccine (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recommendations. Bimervax XBB.1.16 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. Bimervax LP.8.1 is indicated for active immunisation to prevent COVID-19 caused by SARS CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Hipra Human Health S.L.", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/03/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "31/03/2023", "last_updated_date": "05/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bimervax" }, { "category": "Human", "name_of_medicine": "Onerji", "ema_product_number": "EMEA/H/C/006429", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "levodopa;carbidopa", "active_substance": "levodopa;carbidopa", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Onerji is indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease which are not sufficiently controlled by oral anti-Parkinson medicinal products.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Tanabe Pharma GmbH", "european_commission_decision_date": "27/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/04/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "05/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/onerji" }, { "category": "Human", "name_of_medicine": "Palsonify", "ema_product_number": "EMEA/H/C/006636", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "paltusotine", "active_substance": "paltusotine hydrochloride", "therapeutic_area_mesh": "Acromegaly", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01CB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Palsonify is indicated for the medical treatment of adult patients with acromegaly.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Crinetics Pharmaceuticals Europe GmbH", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "05/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/palsonify" }, { "category": "Human", "name_of_medicine": "Ilaris", "ema_product_number": "EMEA/H/C/001109", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000340976", "international_non_proprietary_name_common_name": "canakinumab", "active_substance": "canakinumab", "therapeutic_area_mesh": "Cryopyrin-Associated Periodic Syndromes;Arthritis, Juvenile Rheumatoid;Arthritis, Gouty", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Interleukin inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Periodic fever syndromes Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: Cryopyrin-associated periodic syndromes Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including: Muckle-Wells syndrome (MWS), Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA), Severe forms of familial cold autoinflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash. Tumour necrosis factor receptor associated periodic syndrome (TRAPS) Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS). Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD). Familial Mediterranean fever (FMF) Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF). Ilaris should be given in combination with colchicine, if appropriate. Ilaris is also indicated for the treatment of: Still’s disease Ilaris is indicated for the treatment of active Still’s disease including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate. Gouty arthritis Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "30/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "30/07/2018", "last_updated_date": "05/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ilaris" }, { "category": "Human", "name_of_medicine": "Mvabea", "ema_product_number": "EMEA/H/C/005343", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0023", "international_non_proprietary_name_common_name": "Ebola vaccine (MVA-BN-Filo [recombinant])", "active_substance": "recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP", "therapeutic_area_mesh": "Hemorrhagic Fever, Ebola", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mvabea, as part of the Zabdeno, Mvabea vaccine regimen, is indicated for active immunisation for prevention of disease caused by Ebola virus (Zaire ebolavirus species) in individuals ≥ 1 year of age (see sections 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.   ", "european_commission_decision_date": "26/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/05/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/07/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/05/2026", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "23/07/2020", "last_updated_date": "05/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mvabea" }, { "category": "Human", "name_of_medicine": "Zabdeno", "ema_product_number": "EMEA/H/C/005337", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0022", "international_non_proprietary_name_common_name": "ebola vaccine (Ad26.ZEBOV-GP [recombinant])", "active_substance": "recombinant adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain", "therapeutic_area_mesh": "Hemorrhagic Fever, Ebola", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunization for prevention of disease caused by Ebola virus (Zaire ebolavirus species) in individuals ? 1 year of age.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.   ", "european_commission_decision_date": "28/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/05/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/07/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/05/2026", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "23/07/2020", "last_updated_date": "05/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zabdeno" }, { "category": "Human", "name_of_medicine": "Qutenza", "ema_product_number": "EMEA/H/C/000909", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000340388", "international_non_proprietary_name_common_name": "capsaicin", "active_substance": "capsaicin", "therapeutic_area_mesh": "Neuralgia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N01BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anesthetics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Grunenthal GmbH", "european_commission_decision_date": "29/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/03/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/05/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "24/08/2017", "last_updated_date": "05/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qutenza" }, { "category": "Human", "name_of_medicine": "Leqembi", "ema_product_number": "EMEA/H/C/005966", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000305053", "international_non_proprietary_name_common_name": "lecanemab", "active_substance": "Lecanemab", "therapeutic_area_mesh": "Cognitive Dysfunction;Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E 4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eisai GmbH", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/04/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "28/02/2025", "last_updated_date": "04/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi" }, { "category": "Human", "name_of_medicine": "Rapamune", "ema_product_number": "EMEA/H/C/000273", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000324329", "international_non_proprietary_name_common_name": "sirolimus", "active_substance": "sirolimus", "therapeutic_area_mesh": "Graft Rejection;Kidney Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued. Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/11/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/03/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "50", "first_published_date": "02/08/2018", "last_updated_date": "04/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rapamune" }, { "category": "Human", "name_of_medicine": "Yeytuo", "ema_product_number": "EMEA/H/C/006658", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000338610", "international_non_proprietary_name_common_name": "lenacapavir", "active_substance": "lenacapavir sodium", "therapeutic_area_mesh": "HIV Infections;HIV-1", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX31", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Yeytuo tablet is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV 1 acquisition risk, weighing at least 35 kg for: oral loading oral bridging (see sections 4.2, 4.4 and 5.1) ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland Unlimited Company", "european_commission_decision_date": "24/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "25/07/2025", "last_updated_date": "04/05/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yeytuo" }, { "category": "Human", "name_of_medicine": "Scemblix", "ema_product_number": "EMEA/H/C/005605", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "X/0000256688", "international_non_proprietary_name_common_name": "asciminib", "active_substance": "asciminib hydrochloride", "therapeutic_area_mesh": "Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (Ph+ CML CP). Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/08/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "20/06/2022", "last_updated_date": "30/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/scemblix" }, { "category": "Human", "name_of_medicine": "mCombriax", "ema_product_number": "EMEA/H/C/006472", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "influenza mRNA vaccine;COVID-19 mRNA vaccine", "active_substance": "single-stranded, 5’-capped messenger RNAs (mRNAs) produced using a cell-free in vitro transcription from the corresponding DNA template, encoding seasonal influenza haemagglutinin (HA) glycoproteins: A/H1N1, A/H3N2, B/Victoria", "therapeutic_area_mesh": "Influenza, Human;COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07B", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "mCombriax is indicated for active immunisation for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Moderna Biotech Spain, S.L.", "european_commission_decision_date": "20/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/04/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "30/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mcombriax" }, { "category": "Human", "name_of_medicine": "mResvia", "ema_product_number": "EMEA/H/C/006278", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000312911", "international_non_proprietary_name_common_name": "respiratory syncytial virus mRNA vaccine", "active_substance": "Single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein F stabilised in the prefusion conformation", "therapeutic_area_mesh": "Respiratory Syncytial Virus Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other viral vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "mResvia is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in adults 18 years of age and older. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Moderna Biotech Spain, S.L.", "european_commission_decision_date": "27/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "28/06/2024", "last_updated_date": "30/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mresvia" }, { "category": "Human", "name_of_medicine": "Neuraceq", "ema_product_number": "EMEA/H/C/002553", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000342795", "international_non_proprietary_name_common_name": "florbetaben (18F)", "active_substance": "florbetaben (18F)", "therapeutic_area_mesh": "Radionuclide Imaging;Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Neuraceq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of ? amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Neuraceq should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lantheus Germany GmbH", "european_commission_decision_date": "28/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/02/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "12/03/2018", "last_updated_date": "28/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neuraceq" }, { "category": "Human", "name_of_medicine": "Xromi", "ema_product_number": "EMEA/H/C/004837", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000296554", "international_non_proprietary_name_common_name": "hydroxycarbamide", "active_substance": "hydroxycarbamide", "therapeutic_area_mesh": "Anemia, Sickle Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xromi is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 9 months of age.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lipomed GmbH", "european_commission_decision_date": "07/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/07/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "08/07/2019", "last_updated_date": "28/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xromi" }, { "category": "Human", "name_of_medicine": "Siklos", "ema_product_number": "EMEA/H/C/000689", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000341113", "international_non_proprietary_name_common_name": "hydroxycarbamide", "active_substance": "hydroxycarbamide", "therapeutic_area_mesh": "Anemia, Sickle Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic sickle-cell syndrome.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Theravia", "european_commission_decision_date": "28/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/06/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "31/05/2018", "last_updated_date": "28/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/siklos" }, { "category": "Human", "name_of_medicine": "Darzalex", "ema_product_number": "EMEA/H/C/004077", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/000031294", "international_non_proprietary_name_common_name": "daratumumab", "active_substance": "daratumumab", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;monoclonal antibodies and antibody drug conjugates", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Multiple Myeloma  Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1). in as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. Smouldering multiple myeloma Darzalex as monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma. Light chain (AL) amyloidosis Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/03/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/05/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "31/08/2018", "last_updated_date": "28/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex" }, { "category": "Human", "name_of_medicine": "Micardis", "ema_product_number": "EMEA/H/C/000209", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000288281", "international_non_proprietary_name_common_name": "telmisartan", "active_substance": "telmisartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Angiotensin II antagonists, plain", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "18/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/12/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "22/05/2018", "last_updated_date": "28/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/micardis" }, { "category": "Human", "name_of_medicine": "MicardisPlus", "ema_product_number": "EMEA/H/C/000413", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000342542", "international_non_proprietary_name_common_name": "telmisartan;hydrochlorothiazide", "active_substance": "telmisartan;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. MicardisPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone. MicardisPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on MicardisPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "28/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "38", "first_published_date": "06/04/2017", "last_updated_date": "28/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/micardisplus" }, { "category": "Human", "name_of_medicine": "Tecentriq", "ema_product_number": "EMEA/H/C/004143", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000296544", "international_non_proprietary_name_common_name": "atezolizumab", "active_substance": "atezolizumab", "therapeutic_area_mesh": "Carcinoma, Transitional Cell;Carcinoma, Non-Small-Cell Lung;Urologic Neoplasms;Breast Neoplasms;Small Cell Lung Carcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC32", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Urothelial carcinoma Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC): after prior platinum containing chemotherapy, or who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1). Early-stage non-small cell lung cancer (NSCLC) Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR mutant or ALK positive NSCLC (see section 5.1 for selection criteria). Advanced NSCLC  Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).Tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK positive NSCLC (see section 5.1).Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1).Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy (see section 5.1 for selection criteria).Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving Tecentriq (see section 5.1).Small cell lung cancer (SCLC)Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1). Triple-negative breast cancer (TNBC)Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.Hepatocellular carcinomaTecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy (see section 5.1). Urothelial carcinoma (UC) Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC: after prior platinum containing chemotherapy, or who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1). Early-stage non-small cell lung cancer (NSCLC) Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR mutant or ALK positive NSCLC (see section 5.1 for selection criteria). Advanced NSCLC  Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC. In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).Tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK positive NSCLC (see section 5.1).Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumours have a PD-L1 expression ≥ 50% TC or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1).Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy (see section 5.1 for selection criteria).Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving Tecentriq (see section 5.1).Small cell lung cancer (SCLC) Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1). Triple-negative breast cancer (TNBC)Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.Hepatocellular carcinoma (HCC)Tecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable HCC who have not received prior systemic therapy (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/07/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "38", "first_published_date": "09/08/2018", "last_updated_date": "28/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tecentriq" }, { "category": "Human", "name_of_medicine": "Perjeta", "ema_product_number": "EMEA/H/C/002547", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000307073", "international_non_proprietary_name_common_name": "pertuzumab", "active_substance": "pertuzumab", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;monoclonal antibodies and antibody drug conjugates", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Metastatic Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. Neoadjuvant Treatment of Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH ", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/03/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "31/05/2018", "last_updated_date": "28/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/perjeta" }, { "category": "Human", "name_of_medicine": "Dazublys", "ema_product_number": "EMEA/H/C/006219", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000304280", "international_non_proprietary_name_common_name": "trastuzumab", "active_substance": "trastuzumab", "therapeutic_area_mesh": "Breast Neoplasms;Stomach Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Metastatic breast cancer Dazublys is indicated for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor-positive patients must also have failed hormonal therapy unless patients are unsuitable for these treatments. in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor-positive MBC, not previously treated with trastuzumab. Early breast cancer Dazublys is indicated for the treatment of adult patients with HER2-positive early breast cancer. (EBC). following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1). following adjuvant chemotherapy with doxorubicin and cyclophosphamide in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Dazublys therapy for locally advanced (including inflammatory) disease or tumors> 2 cm in diameter (see sections 4.4 and 5.1). Dazublys should only be used in patients with metastatic or early breast cancer whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1). Metastatic gastric cancer Dazublys in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Dazublys should only be used in patients with metastatic gastric cancer (MGC) whose tumors have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result or by an IHC 3+ result. Accurate and validated assay methods should be used (see sections 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CuraTeQ Biologics s.r.o", "european_commission_decision_date": "19/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "12/08/2025", "last_updated_date": "28/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dazublys" }, { "category": "Human", "name_of_medicine": "Vfend", "ema_product_number": "EMEA/H/C/000387", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000284468", "international_non_proprietary_name_common_name": "voriconazole", "active_substance": "voriconazole", "therapeutic_area_mesh": "Candidiasis;Mycoses;Aspergillosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of in candidaemianon-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Vfend should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "10/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/12/2001", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/03/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "58", "first_published_date": "06/06/2018", "last_updated_date": "28/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vfend" }, { "category": "Human", "name_of_medicine": "Balversa", "ema_product_number": "EMEA/H/C/006050", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000340655", "international_non_proprietary_name_common_name": "erdafitinib", "active_substance": "Erdafitinib", "therapeutic_area_mesh": "Urologic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EN01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.", "european_commission_decision_date": "24/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "28/06/2024", "last_updated_date": "28/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/balversa" }, { "category": "Human", "name_of_medicine": "Besremi", "ema_product_number": "EMEA/H/C/004128", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000334453", "international_non_proprietary_name_common_name": "ropeginterferon alfa-2b", "active_substance": "ropeginterferon alfa-2b", "therapeutic_area_mesh": "Polycythemia Vera", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AOP Orphan Pharmaceuticals GmbH", "european_commission_decision_date": "24/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/02/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/02/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "12/12/2018", "last_updated_date": "24/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/besremi" }, { "category": "Human", "name_of_medicine": "Beyfortus", "ema_product_number": "EMEA/H/C/005304", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319983", "international_non_proprietary_name_common_name": "nirsevimab", "active_substance": "nirsevimab", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BD08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:i.        Neonates and infants during their first RSV season.ii.        Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).Beyfortus should be used in accordance with official recommendations. Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:i.          Neonates and infants during their first RSV season.ii.         Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).Beyfortus should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/10/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "14/09/2022", "last_updated_date": "24/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/beyfortus" }, { "category": "Human", "name_of_medicine": "Epidyolex", "ema_product_number": "EMEA/H/C/004675", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000303055", "international_non_proprietary_name_common_name": "cannabidiol", "active_substance": "cannabidiol", "therapeutic_area_mesh": "Lennox Gastaut Syndrome;Epilepsies, Myoclonic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Jazz Pharmaceuticals Ireland Limited", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "04/10/2019", "last_updated_date": "24/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/epidyolex" }, { "category": "Human", "name_of_medicine": "Advate", "ema_product_number": "EMEA/H/C/000520", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000254887", "international_non_proprietary_name_common_name": "octocog alfa", "active_substance": "octocog alfa", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). Advate does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Manufacturing Austria AG", "european_commission_decision_date": "21/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/03/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "14/06/2018", "last_updated_date": "24/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/advate" }, { "category": "Human", "name_of_medicine": "Caelyx pegylated liposomal", "ema_product_number": "EMEA/H/C/000089", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000340616", "international_non_proprietary_name_common_name": "doxorubicin", "active_substance": "doxorubicin hydrochloride", "therapeutic_area_mesh": "Sarcoma, Kaposi;Multiple Myeloma;Ovarian Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01DB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Caelyx pegylated liposomal is indicated: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk; for treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen; in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant; for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Caelyx pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standarddoxorubicin (or other anthracycline).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Baxter Holding B.V.", "european_commission_decision_date": "24/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/02/1996", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "40", "first_published_date": "22/05/2018", "last_updated_date": "24/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/caelyx-pegylated-liposomal" }, { "category": "Human", "name_of_medicine": "Stelara", "ema_product_number": "EMEA/H/C/000958", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000290099", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Psoriasis;Arthritis, Psoriatic;Crohn Disease;Colitis, Ulcerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adult Crohn’s DiseaseStelara is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist.Paediatric Crohn's DiseaseStelara is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.Ulcerative colitisStelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. Plaque psoriasisStelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1). Paediatric plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.Psoriatic arthritis (PsA)Stelara, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease modifying anti rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "07/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "52", "first_published_date": "20/08/2018", "last_updated_date": "24/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/stelara" }, { "category": "Human", "name_of_medicine": "Striascan", "ema_product_number": "EMEA/H/C/004745", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000341575", "international_non_proprietary_name_common_name": "ioflupane (123l)", "active_substance": "ioflupane (123l)", "therapeutic_area_mesh": "Radionuclide Imaging;Dementia;Movement Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09AB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Striascan is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum: In adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy. Striascan is unable to discriminate between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy. In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease. Striascan is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CIS bio international", "european_commission_decision_date": "24/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/06/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "02/08/2019", "last_updated_date": "24/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/striascan" }, { "category": "Human", "name_of_medicine": "Ondibta", "ema_product_number": "EMEA/H/C/006136", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000338869", "international_non_proprietary_name_common_name": "insulin glargine", "active_substance": "insulin glargine", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gan & Lee Pharmaceuticals Europe GmbH", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "14/11/2025", "last_updated_date": "24/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ondibta" }, { "category": "Human", "name_of_medicine": "Cenrifki", "ema_product_number": "EMEA/H/C/006386", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tolebrutinib", "active_substance": "tolebrutinib", "therapeutic_area_mesh": "Multiple Sclerosis, Chronic Progressive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS) in adults", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/04/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cenrifki" }, { "category": "Human", "name_of_medicine": "Itvisma", "ema_product_number": "EMEA/H/C/006498", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "onasemnogene abeparvovec", "active_substance": "onasemnogene abeparvovec", "therapeutic_area_mesh": "Muscular Atrophy, Spinal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of 5q spinal muscular atrophy (SMA)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/04/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/itvisma" }, { "category": "Human", "name_of_medicine": "Palbociclib Viatris", "ema_product_number": "EMEA/H/C/006624", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "palbociclib", "active_substance": "Palbociclib", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EF01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of breast cancer. ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/04/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/palbociclib-viatris" }, { "category": "Human", "name_of_medicine": "Redemplo", "ema_product_number": "EMEA/H/C/006579", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "plozasiran", "active_substance": "plozasiran", "therapeutic_area_mesh": "Hyperlipoproteinemia Type I", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of familial chylomicronaemia syndrome (FCS).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Arrowhead Pharmaceuticals Ireland Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/04/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/redemplo" }, { "category": "Human", "name_of_medicine": "Rexatilux", "ema_product_number": "EMEA/H/C/006634", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ranibizumab", "active_substance": "ranibizumab", "therapeutic_area_mesh": "Wet Macular Degeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adults with neovascular (wet) age-related macular degeneration (AMD), visual impairment and other retinopathies.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intas Third Party Sales 2005 S.L.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/04/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rexatilux" }, { "category": "Human", "name_of_medicine": "Viokat", "ema_product_number": "EMEA/H/C/006576", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "diazoxide choline", "active_substance": "diazoxide choline", "therapeutic_area_mesh": "Prader-Willi Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult and paediatric patients with Prader-Willi syndrome (PWS).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/04/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/viokat" }, { "category": "Human", "name_of_medicine": "Vysribli (previously Denosumab Intas)", "ema_product_number": "EMEA/H/C/006797", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000317407", "international_non_proprietary_name_common_name": "Vysribli", "active_substance": "denosumab", "therapeutic_area_mesh": "Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intas Third Party Sales 2005 S.L.", "european_commission_decision_date": "05/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "19/09/2025", "last_updated_date": "24/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vysribli-previously-denosumab-intas" }, { "category": "Human", "name_of_medicine": "Terrosa", "ema_product_number": "EMEA/H/C/003916", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000332460", "international_non_proprietary_name_common_name": "teriparatide", "active_substance": "teriparatide", "therapeutic_area_mesh": "Osteoporosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Terrosa is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/01/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "23/02/2018", "last_updated_date": "23/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/terrosa" }, { "category": "Human", "name_of_medicine": "Kinpeygo", "ema_product_number": "EMEA/H/C/005653", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000321405", "international_non_proprietary_name_common_name": "budesonide", "active_substance": "budesonide, micronised", "therapeutic_area_mesh": "Glomerulonephritis, IGA", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A07EA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antidiarrheals, intestinal antiinflammatory / antiinfective agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kinpeygo is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stada Arzneimittel AG", "european_commission_decision_date": "19/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/07/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "17/05/2022", "last_updated_date": "23/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kinpeygo" }, { "category": "Human", "name_of_medicine": "Jayempi", "ema_product_number": "EMEA/H/C/005055", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000296298", "international_non_proprietary_name_common_name": "azathioprine", "active_substance": "azathioprine", "therapeutic_area_mesh": "Graft Rejection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. Azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). Jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. Jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases: severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – DMARDs) auto-immune hepatitis  systemic lupus erythematosus dermatomyositis polyarteritis nodosa pemphigus vulgaris and bullous pemphigoid Behçet’s disease refractory auto-immune haemolytic anaemia, caused by warm IgG antibodies chronic refractory idiopathic thrombocytopenic purpura Jayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (IBD) (Crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. It is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3 Jayempi is indicated for the treatment of generalised myasthenia gravis. Depending on the severity of the disease, Jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lipomed GmbH", "european_commission_decision_date": "13/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/06/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "20/04/2021", "last_updated_date": "23/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jayempi" }, { "category": "Human", "name_of_medicine": "Aptivus", "ema_product_number": "EMEA/H/C/000631", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000342540", "international_non_proprietary_name_common_name": "tipranavir", "active_substance": "tipranavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors. Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options. This indication is based on the results of two phase-III studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years. In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, co-administered with low-dose ritonavir.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/07/2005", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/10/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "44", "first_published_date": "10/11/2017", "last_updated_date": "23/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aptivus" }, { "category": "Human", "name_of_medicine": "Praxbind", "ema_product_number": "EMEA/H/C/003986", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000342414", "international_non_proprietary_name_common_name": "idarucizumab", "active_substance": "idarucizumab", "therapeutic_area_mesh": "Hemorrhage", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required: for emergency surgery/urgent procedures; in life-threatening or uncontrolled bleeding.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "09/11/2017", "last_updated_date": "23/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/praxbind" }, { "category": "Human", "name_of_medicine": "Jemperli", "ema_product_number": "EMEA/H/C/005204", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000335826", "international_non_proprietary_name_common_name": "dostarlimab", "active_substance": "dostarlimab", "therapeutic_area_mesh": "Endometrial Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FF07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic Agents and Antibody Drug Conjugates", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Jemperli is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. Jemperli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability‑high (MSI‑H) recurrent or advanced EC that has progressed on or following prior treatment with a platinum‑containing regimen.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "31/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/02/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/04/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "03/05/2021", "last_updated_date": "23/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli" }, { "category": "Human", "name_of_medicine": "Zilbrysq", "ema_product_number": "EMEA/H/C/005450", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314736", "international_non_proprietary_name_common_name": "zilucoplan", "active_substance": "zilucoplan", "therapeutic_area_mesh": "Myasthenia Gravis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AJ06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zilbrysq is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma S.A.  ", "european_commission_decision_date": "19/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/12/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "15/09/2023", "last_updated_date": "23/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zilbrysq" }, { "category": "Human", "name_of_medicine": "Opsumit", "ema_product_number": "EMEA/H/C/002697", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000324354", "international_non_proprietary_name_common_name": "macitentan", "active_substance": "macitentan", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. Paediatric populationOpsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥ 40 kg with WHO Functional Class (FC) II to III. Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 2 years to less than 18 years with WHO Functional Class (FC) II to III.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.  ", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/12/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "23/08/2018", "last_updated_date": "23/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opsumit" }, { "category": "Human", "name_of_medicine": "Nulojix", "ema_product_number": "EMEA/H/C/002098", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000341345", "international_non_proprietary_name_common_name": "belatacept", "active_substance": "belatacept", "therapeutic_area_mesh": "Graft Rejection;Kidney Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA28", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nulojix, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant. ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "16/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/04/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/06/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "01/09/2017", "last_updated_date": "23/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nulojix" }, { "category": "Human", "name_of_medicine": "Taltz", "ema_product_number": "EMEA/H/C/003943", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323136", "international_non_proprietary_name_common_name": "ixekizumab", "active_substance": "ixekizumab", "therapeutic_area_mesh": "Psoriasis;Arthritis, Psoriatic;Axial Spondyloarthritis;Arthritis, Juvenile", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Plaque psoriasisTaltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Paediatric plaque psoriasisTaltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy.Psoriatic arthritisTaltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies. Axial spondyloarthritis Ankylosing spondylitis (radiographic axial spondyloarthritis)Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis Taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).Juvenile idiopathic arthritis (JIA)Juvenile psoriatic arthritis (JPsA)Taltz, alone or in combination with methotrexate, is indicated for the treatment of active JPsA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.Enthesitis-related arthritis (ERA)Taltz, alone or in combination with methotrexate, is indicated for the treatment of active ERA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly and Company (Ireland) Limited", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/02/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/04/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "30/07/2018", "last_updated_date": "23/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/taltz" }, { "category": "Human", "name_of_medicine": "Amgevita", "ema_product_number": "EMEA/H/C/004212", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000327651", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Arthritis, Psoriatic;Colitis, Ulcerative;Arthritis, Juvenile Rheumatoid;Spondylitis, Ankylosing;Psoriasis;Crohn Disease;Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis  Amgevita in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.  Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.  Amgevita reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Amgevita in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Amgevita is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Amgevita is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Amgevita is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs. Psoriatic arthritis Amgevita is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Amgevita reduces the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and improves physical function. Psoriasis Amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Amgevita is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Amgevita is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Amgevita is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Amgevita is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Amgevita is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/01/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "20/07/2018", "last_updated_date": "23/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amgevita" }, { "category": "Human", "name_of_medicine": "Movymia", "ema_product_number": "EMEA/H/C/004368", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000336404", "international_non_proprietary_name_common_name": "teriparatide", "active_substance": "teriparatide", "therapeutic_area_mesh": "Osteoporosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Movymia is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "STADA Arzneimittel AG", "european_commission_decision_date": "22/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "19/02/2018", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/movymia" }, { "category": "Human", "name_of_medicine": "Vyndaqel", "ema_product_number": "EMEA/H/C/002294", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000297114", "international_non_proprietary_name_common_name": "tafamidis", "active_substance": "tafamidis", "therapeutic_area_mesh": "Amyloidosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/11/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "12/10/2017", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vyndaqel" }, { "category": "Human", "name_of_medicine": "Volibris", "ema_product_number": "EMEA/H/C/000839", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000335136", "international_non_proprietary_name_common_name": "ambrisentan", "active_substance": "ambrisentan", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).  Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "16/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/04/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "26/04/2017", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/volibris" }, { "category": "Human", "name_of_medicine": "Dabigatran Etexilate Accord", "ema_product_number": "EMEA/H/C/005639", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0003", "international_non_proprietary_name_common_name": "dabigatran etexilate", "active_substance": "dabigatran etexilate mesilate", "therapeutic_area_mesh": "Venous Thromboembolism;Arthroplasty, Replacement", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AE07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of venous thromboembolic events", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "05/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/03/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "24/01/2023", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dabigatran-etexilate-accord" }, { "category": "Human", "name_of_medicine": "Forxiga", "ema_product_number": "EMEA/H/C/002322", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310736", "international_non_proprietary_name_common_name": "dapagliflozin", "active_substance": "dapagliflozin propanediol monohydrate", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2;Heart Failure, Systolic;Heart Failure;Renal Insufficiency, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BK01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Type 2 diabetes mellitus Forxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance. in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Forxiga is indicated in adults for the treatment of chronic kidney disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/11/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "12/10/2017", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/forxiga" }, { "category": "Human", "name_of_medicine": "Erleada", "ema_product_number": "EMEA/H/C/004452", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319048", "international_non_proprietary_name_common_name": "apalutamide", "active_substance": "apalutamide", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Erleada is indicated: in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/11/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/01/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "19/03/2019", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/erleada" }, { "category": "Human", "name_of_medicine": "Ozempic", "ema_product_number": "EMEA/H/C/004174", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000295392", "international_non_proprietary_name_common_name": "semaglutide", "active_substance": "semaglutide", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/02/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "31/05/2018", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic" }, { "category": "Human", "name_of_medicine": "Rybelsus", "ema_product_number": "EMEA/H/C/004953", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000295392", "international_non_proprietary_name_common_name": "semaglutide", "active_substance": "semaglutide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in combination with other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/04/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "27/05/2020", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rybelsus" }, { "category": "Human", "name_of_medicine": "Noxafil", "ema_product_number": "EMEA/H/C/000610", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000263360", "international_non_proprietary_name_common_name": "posaconazole", "active_substance": "posaconazole", "therapeutic_area_mesh": "Candidiasis;Mycoses;Coccidioidomycosis;Aspergillosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Triazole and triazole derivatives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following invasive fungal infections in adult and paediatric patients from 2 years of age:  Invasive aspergillosis  Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.   Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.  Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in adults and paediatric patients from 2 years of age:  Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;  Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections.   Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in adults with oropharyngeal candidiasis. Noxafil gastro-resistant tablets are indicated for use in the treatment of the following invasive fungal infections in adults and paediatric patients from 2 years of age weighing more than 40 kg:  Invasive aspergillosis Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.   Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.   Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in adults and paediatric patients from 2 years of age weighing more than 40 kg:  Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;  Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.   Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):  Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products; Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.  Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.   Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:  Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;  Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.   Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. Noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following invasive fungal infections in paediatric patients from 2 years of age:  Invasive aspergillosis Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.   Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.   Noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age:  Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;  - Haematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp and Dohme B.V", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/07/2005", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/10/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "43", "first_published_date": "21/04/2017", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/noxafil" }, { "category": "Human", "name_of_medicine": "Rotarix", "ema_product_number": "EMEA/H/C/000639", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000305060", "international_non_proprietary_name_common_name": "rotavirus vaccine, live", "active_substance": "human rotavirus, live attenuated", "therapeutic_area_mesh": "Immunization;Rotavirus Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection. The use of Rotarix should be based on official recommendation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "20/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/02/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "46", "first_published_date": "26/07/2018", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rotarix" }, { "category": "Human", "name_of_medicine": "Irbesartan Zentiva (previously Irbesartan Winthrop)", "ema_product_number": "EMEA/H/C/000785", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000338445", "international_non_proprietary_name_common_name": "irbesartan", "active_substance": "irbesartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva k.s.", "european_commission_decision_date": "21/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/01/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "02/08/2017", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/irbesartan-zentiva" }, { "category": "Human", "name_of_medicine": "Keytruda", "ema_product_number": "EMEA/H/C/003820", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000293815", "international_non_proprietary_name_common_name": "pembrolizumab", "active_substance": "pembrolizumab", "therapeutic_area_mesh": "Melanoma;Hodgkin Disease;Carcinoma, Renal Cell;Carcinoma, Non-Small-Cell Lung;Carcinoma, Transitional Cell;Squamous Cell Carcinoma of Head and Neck;Urologic Neoplasms;Endometrial Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FF02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Melanoma Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. Keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC, or with Stage III melanoma and lymph node involvement who have undergone complete resection. Non small cell lung carcinoma (NSCLC) Keytruda, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non small cell lung carcinoma at high risk of recurrence in adults Keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5.1). Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations. Keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. Keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. Malignant pleural mesothelioma (MPM) Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma. Classical Hodgkin lymphoma (cHL) Keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. Urothelial carcinoma Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy.Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10. Head and neck squamous cell carcinoma (HNSCC) Keytruda as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1. Keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 FU) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a CPS ≥ 1. Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a ? 50% TPS and progressing on or after platinum containing chemotherapy. Renal cell carcinoma (RCC) Keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. Keytruda, in combination with lenvatinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. Keytruda as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5.1). Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers Colorectal cancer (CRC)Keytruda as monotherapy is indicated for theadults with MSI-H or dMMR colorectal cancer in the following settings: first line treatment of metastatic microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults; treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  Non-colorectal cancersKeytruda as monotherapy is indicated for the treatment of the following MSI H or dMMR tumours in adults with: advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation; unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. Oesophageal carcinoma Keytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD L1 with a CPS ≥ 10. Triple negative breast cancer (TNBC) Keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. Keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. Endometrial carcinoma (EC) Keytruda, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy.  Keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. Cervical cancer Keytruda, in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy), is indicated for the treatment of FIGO 2014 Stage III - IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.  Keytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD L1 with a CPS ≥ 1. Gastric or gastro-oesophageal junction (GEJ) adenocarcinoma Keytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1. Keytruda, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD L1 with a CPS ≥ 1 (see section 5.1). Biliary tract carcinoma (BTC) Keytruda, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults. Ovarian Cancer Keytruda, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD‑L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "30/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/07/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "70", "first_published_date": "21/06/2018", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda" }, { "category": "Human", "name_of_medicine": "Enflonsia", "ema_product_number": "EMEA/H/C/006497", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "clesrovimab", "active_substance": "clesrovimab", "therapeutic_area_mesh": "Respiratory Syncytial Virus Vaccines", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BD10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Enflonsia is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.Enflonsia should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp Dohme Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/04/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/09/2025", "last_updated_date": "22/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enflonsia" }, { "category": "Human", "name_of_medicine": "Verquvo", "ema_product_number": "EMEA/H/C/005319", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000304275", "international_non_proprietary_name_common_name": "vericiguat", "active_substance": "vericiguat", "therapeutic_area_mesh": "Heart Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic chronic heart failure", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/07/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "19/05/2021", "last_updated_date": "21/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/verquvo" }, { "category": "Human", "name_of_medicine": "Veoza", "ema_product_number": "EMEA/H/C/005851", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000341632", "international_non_proprietary_name_common_name": "fezolinetant", "active_substance": "fezolinetant", "therapeutic_area_mesh": "Menopause;Hot Flashes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G02CX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other gynecologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma Europe B.V.", "european_commission_decision_date": "21/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/10/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/12/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "20/12/2023", "last_updated_date": "21/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/veoza" }, { "category": "Human", "name_of_medicine": "Arsenic trioxide medac", "ema_product_number": "EMEA/H/C/005218", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000338900", "international_non_proprietary_name_common_name": "arsenic trioxide", "active_substance": "arsenic trioxide", "therapeutic_area_mesh": "Leukemia, Promyelocytic, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 10³/?l) in combination with all-trans-retinoic acid (ATRA) Relapsed/refractory APL (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR?) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "european_commission_decision_date": "21/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "01/10/2020", "last_updated_date": "21/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/arsenic-trioxide-medac" }, { "category": "Human", "name_of_medicine": "Evrysdi", "ema_product_number": "EMEA/H/C/005145", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323786", "international_non_proprietary_name_common_name": "risdiplam", "active_substance": "risdiplam", "therapeutic_area_mesh": "Muscular Atrophy, Spinal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.  ", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH ", "european_commission_decision_date": "20/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/02/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "04/05/2021", "last_updated_date": "21/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evrysdi" }, { "category": "Human", "name_of_medicine": "Orphacol", "ema_product_number": "EMEA/H/C/001250", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000342032", "international_non_proprietary_name_common_name": "cholic acid", "active_substance": "cholic acid", "therapeutic_area_mesh": "Digestive System Diseases;Metabolism, Inborn Errors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A05AA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bile acids and derivatives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Orphacol is indicated for the treatment of inborn errors in primary bile acid synthesis due to3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency ininfants, children and adolescents aged 1 month to 18 years and adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Theravia", "european_commission_decision_date": "20/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "04/08/2017", "last_updated_date": "21/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orphacol" }, { "category": "Human", "name_of_medicine": "Ferriprox", "ema_product_number": "EMEA/H/C/000236", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000342195", "international_non_proprietary_name_common_name": "deferiprone", "active_substance": "Deferiprone", "therapeutic_area_mesh": "beta-Thalassemia;Iron Overload", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate. Ferriprox in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A.", "european_commission_decision_date": "20/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/08/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "04/07/2017", "last_updated_date": "21/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ferriprox" }, { "category": "Human", "name_of_medicine": "Roteas", "ema_product_number": "EMEA/H/C/004339", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2409", "international_non_proprietary_name_common_name": "edoxaban", "active_substance": "edoxaban tosilate", "therapeutic_area_mesh": "Stroke;Venous Thromboembolism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AF03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Berlin-Chemie AG", "european_commission_decision_date": "20/11/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "30/11/2017", "last_updated_date": "20/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/roteas" }, { "category": "Human", "name_of_medicine": "Lixiana", "ema_product_number": "EMEA/H/C/002629", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000272457", "international_non_proprietary_name_common_name": "edoxaban", "active_substance": "edoxaban tosilate", "therapeutic_area_mesh": "Stroke;Venous Thromboembolism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Daiichi Sankyo Europe GmbH", "european_commission_decision_date": "24/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/06/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "26/07/2018", "last_updated_date": "20/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lixiana" }, { "category": "Human", "name_of_medicine": "Aclasta", "ema_product_number": "EMEA/H/C/000595", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000341352", "international_non_proprietary_name_common_name": "zoledronic acid", "active_substance": "zoledronic acid", "therapeutic_area_mesh": "Osteoporosis;Osteitis Deformans;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture. Treatment of Paget's disease of the bone.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz Pharmaceuticals d.d.", "european_commission_decision_date": "16/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/04/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "23/03/2017", "last_updated_date": "20/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aclasta" }, { "category": "Human", "name_of_medicine": "Tepmetko", "ema_product_number": "EMEA/H/C/005524", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000337926", "international_non_proprietary_name_common_name": "tepotinib", "active_substance": "tepotinib hydrochloride monohydrate", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Europe B.V.", "european_commission_decision_date": "17/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/02/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "05/05/2022", "last_updated_date": "17/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tepmetko" }, { "category": "Veterinary", "name_of_medicine": "Nobivac NXT HCPChFeLV", "ema_product_number": "EMEA/V/C/006520", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "feline calicivirosis, feline rhinotracheitis, feline panleucopenia, feline chlamydiosis (live) and feline leukemia (RNA replicon particle) vaccine", "active_substance": "feline herpesvirus 1 (FHV), strain G2620A, live;feline calicivirus (FCV), strain F9, live;feline panleucopenia virus (FPL), strain MW-1;chlamydia felis, strain Baker, live;feline leukemia virus (FeLV) glycoprotein RNA-particle", "therapeutic_area_mesh": "", "species_veterinary": "Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for felidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/04/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/04/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobivac-nxt-hcpchfelv" }, { "category": "Human", "name_of_medicine": "Rezurock", "ema_product_number": "EMEA/H/C/006421", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "belumosudil", "active_substance": "belumosudil mesilate", "therapeutic_area_mesh": "Graft vs Host Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA48", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rezurock is indicated for the treatment of adults and paediatric patients (12 years and older with a body weight of at least 40 kg) with chronic graft-versus-host disease (cGVHD) when other treatment options provide limited clinical benefit, are not suitable, or have been exhausted. ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/01/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/03/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/10/2025", "last_updated_date": "17/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rezurock" }, { "category": "Human", "name_of_medicine": "Livmarli", "ema_product_number": "EMEA/H/C/005857", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "X/0015", "international_non_proprietary_name_common_name": "maralixibat chloride", "active_substance": "Maralixibat chloride", "therapeutic_area_mesh": "Alagille Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A05AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for bile therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Livmarli is indicated for the treatment of: Cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older, Progressive familial intrahepatic cholestasis (PFIC) in patients 3 months of age and older. Livmarli tablets is indicated in adults and adolescents 12 years and older for the treatment of: Cholestatic pruritus in patients with Alagille syndrome (ALGS), Progressive familial intrahepatic cholestasis (PFIC).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mirum Pharmaceuticals International B.V.", "european_commission_decision_date": "18/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "12/10/2022", "last_updated_date": "17/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/livmarli" }, { "category": "Human", "name_of_medicine": "Atriance", "ema_product_number": "EMEA/H/C/000752", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000341350", "international_non_proprietary_name_common_name": "nelarabine", "active_substance": "nelarabine", "therapeutic_area_mesh": "Precursor T-Cell Lymphoblastic Leukemia-Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BB07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz Pharmaceuticals d.d.", "european_commission_decision_date": "16/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "30/04/2018", "last_updated_date": "16/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/atriance" }, { "category": "Human", "name_of_medicine": "Steqeyma", "ema_product_number": "EMEA/H/C/005918", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000334207", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Psoriasis;Arthritis, Psoriatic;Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Crohn’s Disease Steqeyma is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Plaque psoriasis Steqeyma is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1). Paediatric plaque psoriasis Steqeyma is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1). Psoriatic arthritis (PsA) Steqeyma, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "16/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "18/06/2024", "last_updated_date": "16/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/steqeyma" }, { "category": "Human", "name_of_medicine": "Qoyvolma", "ema_product_number": "EMEA/H/C/006649", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000334207", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Psoriasis;Arthritis, Psoriatic;Colitis, Ulcerative;Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adult Crohn’s Disease Qoyvolma is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist.  Paediatric Crohn's Disease  Qoyvolma is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.   Ulcerative colitis Qoyvolma is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic.  Plaque psoriasis Qoyvolma is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A).  Paediatric plaque psoriasis Qoyvolma is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.  Psoriatic arthritis (PsA) Qoyvolma, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "16/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/03/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "28/03/2025", "last_updated_date": "16/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qoyvolma" }, { "category": "Human", "name_of_medicine": "Zolsketil pegylated liposomal", "ema_product_number": "EMEA/H/C/005320", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000340547", "international_non_proprietary_name_common_name": "doxorubicin", "active_substance": "doxorubicin hydrochloride, liposomal", "therapeutic_area_mesh": "Ovarian Neoplasms;Sarcoma, Kaposi;Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01DB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "doxorubicin", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults: • breast cancer that has spread to other parts of the body in patients at risk of heart problems. Zolsketil pegylated liposomal is used on its own for this disease; • advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working; • multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. Zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine); • Kaposi’s sarcoma in patients with AIDS who have a very damaged immune system. Kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. Zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance called Adriamycin. However, in Zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for Adriamycin.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "15/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/03/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/05/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "20/06/2022", "last_updated_date": "16/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zolsketil-pegylated-liposomal" }, { "category": "Human", "name_of_medicine": "Emtricitabine / Tenofovir alafenamide Viatris", "ema_product_number": "EMEA/H/C/006469", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000340699", "international_non_proprietary_name_common_name": "emtricitabine;tenofovir alafenamide", "active_substance": "emtricitabine;tenofovir alafenamide fumarate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Emtricitabine/Tenofovir alafenamide Viatris is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "16/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/07/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "23/05/2025", "last_updated_date": "16/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabine-tenofovir-alafenamide-viatris" }, { "category": "Human", "name_of_medicine": "Ocrevus", "ema_product_number": "EMEA/H/C/004043", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000254616", "international_non_proprietary_name_common_name": "ocrelizumab", "active_substance": "ocrelizumab", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AG08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "29/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "09/08/2018", "last_updated_date": "16/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ocrevus" }, { "category": "Human", "name_of_medicine": "Icatibant Accord", "ema_product_number": "EMEA/H/C/005083", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000333262", "international_non_proprietary_name_common_name": "icatibant", "active_substance": "icatibant acetate", "therapeutic_area_mesh": "Angioedemas, Hereditary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Icatibant Accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1 esterase inhibitor deficiency.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "19/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/07/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "06/09/2021", "last_updated_date": "16/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/icatibant-accord" }, { "category": "Human", "name_of_medicine": "Myqorzo", "ema_product_number": "EMEA/H/C/006228", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000335614", "international_non_proprietary_name_common_name": "aficamten", "active_substance": "aficamten", "therapeutic_area_mesh": "Cardiomyopathy, Hypertrophic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Myqorzo is indicated for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cytokinetics (Ireland) Limited", "european_commission_decision_date": "15/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/12/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/02/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "12/12/2025", "last_updated_date": "16/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/myqorzo" }, { "category": "Human", "name_of_medicine": "Enwylma", "ema_product_number": "EMEA/H/C/006376", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000337514", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "", "therapeutic_area_mesh": "Neoplasms, Bone Tissue;Giant Cell Tumor of Bone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva k.s.", "european_commission_decision_date": "15/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/04/2025", "last_updated_date": "16/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enwylma" }, { "category": "Human", "name_of_medicine": "Jelrix", "ema_product_number": "EMEA/H/C/004594", "medicine_status": "Application withdrawn", "opinion_status": "Negative", "latest_procedure_affecting_product_information": "EMEA/H/C/004594", "international_non_proprietary_name_common_name": "autologous cartilage-derived articular chondrocytes, in-vitro expanded", "active_substance": "", "therapeutic_area_mesh": "Knee Injuries;Cartilage Diseases;Knee Joint", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Repair of symptomatic, localised, full-thickness cartilage defects of the knee joint grade III or IV ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "TETEC Tissue Engineering Technologies AG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "11/11/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/07/2025", "last_updated_date": "15/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jelrix" }, { "category": "Human", "name_of_medicine": "Kygevvi", "ema_product_number": "EMEA/H/C/005119", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "doxecitine;doxribtimine", "active_substance": "doxecitine;Doxribtimine", "therapeutic_area_mesh": "Mitochondrial Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX29", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kygevvi is indicated for the treatment of paediatric and adult patients with genetically confirmed thymidine kinase 2 deficiency (TK2d) with an age of symptom onset on or before 12 years.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "UCB Pharma", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/01/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/01/2026", "last_updated_date": "15/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kygevvi" }, { "category": "Human", "name_of_medicine": "Prialt", "ema_product_number": "EMEA/H/C/000551", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000340402", "international_non_proprietary_name_common_name": "ziconotide", "active_substance": "ziconotide", "therapeutic_area_mesh": "Injections, Spinal;Pain", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02BG08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ziconotide is indicated for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Esteve Pharmaceuticals GmbH", "european_commission_decision_date": "14/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/11/2004", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/02/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "02/07/2018", "last_updated_date": "15/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prialt" }, { "category": "Human", "name_of_medicine": "Lorviqua", "ema_product_number": "EMEA/H/C/004646", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000292366", "international_non_proprietary_name_common_name": "lorlatinib", "active_substance": "Lorlatinib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01ED05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK?positive advanced NSCLC whose disease has progressed after: alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "07/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/02/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/05/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "17/06/2019", "last_updated_date": "15/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lorviqua" }, { "category": "Human", "name_of_medicine": "Jorveza", "ema_product_number": "EMEA/H/C/004655", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "X/0000257468", "international_non_proprietary_name_common_name": "budesonide", "active_substance": "Budesonide", "therapeutic_area_mesh": "Esophageal Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A07EA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antidiarrheals, intestinal antiinflammatory / antiinfective agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age). Jorveza 0.2 mg/mL oral suspension is indicated for the treatment of eosinophilic esophagitis (EoE) in paediatric patients 2 to 17 years of age.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dr. Falk Pharma GmbH", "european_commission_decision_date": "08/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "08/01/2018", "last_updated_date": "15/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jorveza" }, { "category": "Human", "name_of_medicine": "Bortezomib Hospira", "ema_product_number": "EMEA/H/C/004207", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000263654", "international_non_proprietary_name_common_name": "bortezomib", "active_substance": "bortezomib", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bortezomib Hospira as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib Hospira in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Hospira in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Hospira in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "16/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/05/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/07/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "07/08/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "08/08/2018", "last_updated_date": "15/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bortezomib-hospira" }, { "category": "Veterinary", "name_of_medicine": "Bluevac BTV (previously Bluevac BTV8)", "ema_product_number": "EMEA/V/C/000156", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated]", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Ovidae;Immunologicals for Bovidae;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/02/2018", "last_updated_date": "14/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bluevac-btv" }, { "category": "Human", "name_of_medicine": "Spevigo", "ema_product_number": "EMEA/H/C/005874", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000337921", "international_non_proprietary_name_common_name": "spesolimab", "active_substance": "spesolimab", "therapeutic_area_mesh": "Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Spevigo is indicated for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age. Spevigo is indicated for the treatment of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "LEO Pharma A/S", "european_commission_decision_date": "14/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "12/10/2022", "last_updated_date": "14/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/spevigo" }, { "category": "Human", "name_of_medicine": "Pavblu", "ema_product_number": "EMEA/H/C/006339", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000339035", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Retinal Vein Occlusion;Choroidal Neovascularization;Diabetes Complications", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pavblu is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual impairment due to diabetic macular oedema (DME) (see section 5.1), visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Technology (Ireland) UC", "european_commission_decision_date": "14/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "31/01/2025", "last_updated_date": "14/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pavblu" }, { "category": "Human", "name_of_medicine": "Aripiprazole Sandoz", "ema_product_number": "EMEA/H/C/004008", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000340511", "international_non_proprietary_name_common_name": "aripiprazole", "active_substance": "aripiprazole", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Sandoz is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "10/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/08/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "15/02/2018", "last_updated_date": "13/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aripiprazole-sandoz" }, { "category": "Human", "name_of_medicine": "Mysimba", "ema_product_number": "EMEA/H/C/003687", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000332676", "international_non_proprietary_name_common_name": "naltrexone;bupropion", "active_substance": "bupropion hydrochloride;naltrexone hydrochloride", "therapeutic_area_mesh": "Obesity;Overweight", "species_veterinary": "", "patient_safety": "Yes", "atc_code_human": "A08AA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiobesity preparations, excl. diet products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension) Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Orexigen Therapeutics Ireland Limited", "european_commission_decision_date": "17/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/12/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "02/07/2018", "last_updated_date": "10/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mysimba" }, { "category": "Veterinary", "name_of_medicine": "Equidormin", "ema_product_number": "EMEA/V/C/006593", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "midazolam", "active_substance": "midazolam", "therapeutic_area_mesh": "", "species_veterinary": "Horses", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CP-Pharma Handelsgesellschaft mbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "09/09/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/04/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/equidormin" }, { "category": "Human", "name_of_medicine": "Mycophenolate mofetil Teva", "ema_product_number": "EMEA/H/C/000882", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000296546", "international_non_proprietary_name_common_name": "mycophenolate mofetil", "active_substance": "mycophenolate mofetil", "therapeutic_area_mesh": "Graft Rejection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mycophenolate mofetil Teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/12/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/02/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "19/03/2018", "last_updated_date": "10/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mycophenolate-mofetil-teva" }, { "category": "Human", "name_of_medicine": "Myfenax", "ema_product_number": "EMEA/H/C/000884", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000296546", "international_non_proprietary_name_common_name": "mycophenolate mofetil", "active_substance": "mycophenolate mofetil", "therapeutic_area_mesh": "Graft Rejection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/12/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/02/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "19/03/2018", "last_updated_date": "10/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/myfenax" }, { "category": "Human", "name_of_medicine": "Mynzepli", "ema_product_number": "EMEA/H/C/006438", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000335832", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications;Retinal Vein Occlusion;Choroidal Neovascularization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mynzepli is indicated for adults for the treatment of- neovascular (wet) age-related macular degeneration (AMD),- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO),- visual impairment due to diabetic macular oedema (DME),- visual impairment due to myopic choroidal neovascularisation (myopic CNV)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Advanz Pharma Limited", "european_commission_decision_date": "07/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/06/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "20/06/2025", "last_updated_date": "10/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mynzepli" }, { "category": "Human", "name_of_medicine": "Myclausen", "ema_product_number": "EMEA/H/C/001218", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000296546", "international_non_proprietary_name_common_name": "mycophenolate mofetil", "active_substance": "mycophenolate mofetil", "therapeutic_area_mesh": "Graft Rejection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Passauer Pharma GmbH", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/10/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "05/03/2018", "last_updated_date": "10/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/myclausen" }, { "category": "Human", "name_of_medicine": "Sorafenib Accord", "ema_product_number": "EMEA/H/C/005921", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000337100", "international_non_proprietary_name_common_name": "sorafenib", "active_substance": "sorafenib tosilate", "therapeutic_area_mesh": "Carcinoma, Hepatocellular;Carcinoma, Renal Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hepatocellular carcinomaSorafenib Accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinomaSorafenib Accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "09/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "14/09/2022", "last_updated_date": "09/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sorafenib-accord" }, { "category": "Human", "name_of_medicine": "Kayshild", "ema_product_number": "EMEA/H/C/006426", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "semaglutide", "active_substance": "semaglutide", "therapeutic_area_mesh": "Non-alcoholic Fatty Liver Disease;Liver Cirrhosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kayshild is indicated in conjunction with diet and exercise for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/01/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/01/2026", "last_updated_date": "09/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kayshild" }, { "category": "Human", "name_of_medicine": "Fylrevy", "ema_product_number": "EMEA/H/C/006213", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "estetrol", "active_substance": "estetrol monohydrate", "therapeutic_area_mesh": "Menopause", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03CA10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in hysterectomised postmenopausal womenHormone replacement therapy (HRT) for oestrogen deficiency symptoms in non-hysterectomised postmenopausal women with at least 12 months since last menses.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/01/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/01/2026", "last_updated_date": "09/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fylrevy" }, { "category": "Human", "name_of_medicine": "Neofordex", "ema_product_number": "EMEA/H/C/004071", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0024", "international_non_proprietary_name_common_name": "dexamethasone", "active_substance": "dexamethasone", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H02AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Corticosteroids for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of multiple myeloma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "THERAVIA", "european_commission_decision_date": "03/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/12/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/03/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "28/05/2018", "last_updated_date": "09/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neofordex" }, { "category": "Human", "name_of_medicine": "Copiktra", "ema_product_number": "EMEA/H/C/005381", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0007/G", "international_non_proprietary_name_common_name": "duvelisib", "active_substance": "duvelisib", "therapeutic_area_mesh": "Leukemia, Lymphocytic, Chronic, B-Cell;Lymphoma, Follicular", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EM04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Copiktra monotherapy is indicated for the treatment of adult patients with:  Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies.  Follicular lymphoma (FL) that is refractory to at least two prior  systemic therapies.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Secura Bio Limited", "european_commission_decision_date": "10/08/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/03/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/05/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "16/02/2026", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "31/05/2021", "last_updated_date": "09/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/copiktra" }, { "category": "Human", "name_of_medicine": "Sibnayal", "ema_product_number": "EMEA/H/C/005407", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000340510", "international_non_proprietary_name_common_name": "potassium citrate;potassium hydrogen carbonate", "active_substance": "potassium citrate monohydrated;potassium hydrogen carbonate", "therapeutic_area_mesh": "Acidosis, Renal Tubular", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A12BA30", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Mineral supplements", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sibnayal is indicated for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Advicenne S.A.", "european_commission_decision_date": "09/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/04/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "03/05/2021", "last_updated_date": "09/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sibnayal" }, { "category": "Human", "name_of_medicine": "Supemtek", "ema_product_number": "EMEA/H/C/006674", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "trivalent influenza vaccine (recombinant, prepared in cell culture)", "active_substance": "A/California/07/2009 (H1N1)pdm09-like strain (A/California/07/2009);A/Texas/50/2012 (H3N2)-like strain (A/Texas/50/2012);B/Brisbane/60/2008-like strain (B/Brisbane/60/2008)", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Supemtek is indicated for active immunisation for the prevention of influenza disease in adults and children from 9 years of age and older. Supemtek should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/01/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/03/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/01/2026", "last_updated_date": "08/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/supemtek" }, { "category": "Human", "name_of_medicine": "Blenrep", "ema_product_number": "EMEA/H/C/006511", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000314500 and EMA/VR/0000314494", "international_non_proprietary_name_common_name": "belantamab mafodotin", "active_substance": "belantamab mafodotin", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Blenrep is indicated in adults for the treatment of relapsed or refractory multiple myeloma: in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "05/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/07/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "23/05/2025", "last_updated_date": "08/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep" }, { "category": "Human", "name_of_medicine": "Yellox", "ema_product_number": "EMEA/H/C/001198", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000296580", "international_non_proprietary_name_common_name": "bromfenac", "active_substance": "bromfenac sodium sesquihydrate", "therapeutic_area_mesh": "Pain, Postoperative;Ophthalmologic Surgical Procedures", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01BC11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of postoperative ocular inflammation following cataract extraction in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bausch + Lomb Ireland Limited", "european_commission_decision_date": "27/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/03/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/05/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "05/04/2017", "last_updated_date": "08/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yellox" }, { "category": "Human", "name_of_medicine": "Agamree", "ema_product_number": "EMEA/H/C/005679", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000338132", "international_non_proprietary_name_common_name": "vamorolone", "active_substance": "vamorolone", "therapeutic_area_mesh": "Muscular Dystrophy, Duchenne", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H02AB18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Glucocorticoids", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Agamree is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Santhera Pharmaceuticals (Deutschland) GmbH", "european_commission_decision_date": "08/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/10/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/12/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "13/10/2023", "last_updated_date": "08/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/agamree" }, { "category": "Human", "name_of_medicine": "Rebif", "ema_product_number": "EMEA/H/C/000136", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000313648", "international_non_proprietary_name_common_name": "interferon beta-1a", "active_substance": "interferon beta-1a", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rebif is indicated for the treatment of: patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis; patients with relapsing multiple sclerosis. In clinical trials, this was characterised by two or more acute exacerbations in the previous two years. Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Europe B.V. ", "european_commission_decision_date": "13/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/05/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "42", "first_published_date": "19/12/2017", "last_updated_date": "08/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rebif" }, { "category": "Human", "name_of_medicine": "Aripiprazole Zentiva", "ema_product_number": "EMEA/H/C/003899", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000337489", "international_non_proprietary_name_common_name": "aripiprazole", "active_substance": "aripiprazole", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva, k.s.", "european_commission_decision_date": "08/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/06/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "06/02/2018", "last_updated_date": "08/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aripiprazole-zentiva" }, { "category": "Human", "name_of_medicine": "Poteligeo", "ema_product_number": "EMEA/H/C/004232", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000339221", "international_non_proprietary_name_common_name": "mogamulizumab", "active_substance": "mogamulizumab", "therapeutic_area_mesh": "Sezary Syndrome;Mycosis Fungoides", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC25", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Kyowa Kirin Holdings B.V.", "european_commission_decision_date": "08/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "21/09/2018", "last_updated_date": "08/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/poteligeo" }, { "category": "Human", "name_of_medicine": "Crysvita", "ema_product_number": "EMEA/H/C/004275", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000339760", "international_non_proprietary_name_common_name": "burosumab", "active_substance": "burosumab", "therapeutic_area_mesh": "Hypophosphatemia, Familial;Hypophosphatemic Rickets, X-Linked Dominant;Osteomalacia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. Crysvita is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Kyowa Kirin Holdings B.V.", "european_commission_decision_date": "07/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/02/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "19/02/2018", "last_updated_date": "08/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/crysvita" }, { "category": "Human", "name_of_medicine": "Rezzayo", "ema_product_number": "EMEA/H/C/005900", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000334715", "international_non_proprietary_name_common_name": "rezafungin", "active_substance": "rezafungin", "therapeutic_area_mesh": "Candidiasis;Candidiasis, Invasive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AX08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rezzayo is indicated for the treatment of invasive candidiasis in adults. Consideration should be given to official guidance on the appropriate use of antifungal agents.  ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mundipharma GmbH", "european_commission_decision_date": "07/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/10/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/12/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "24/01/2024", "last_updated_date": "08/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rezzayo" }, { "category": "Human", "name_of_medicine": "Doptelet", "ema_product_number": "EMEA/H/C/004722", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000255149", "international_non_proprietary_name_common_name": "avatrombopag", "active_substance": "avatrombopag maleate", "therapeutic_area_mesh": "Thrombocytopenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure. Doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Swedish Orphan Biovitrum AB (publ)", "european_commission_decision_date": "22/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "24/04/2019", "last_updated_date": "08/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/doptelet" }, { "category": "Human", "name_of_medicine": "Viramune", "ema_product_number": "EMEA/H/C/000183", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000339673", "international_non_proprietary_name_common_name": "nevirapine", "active_substance": "nevirapine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Viramune 50 mg/5 mL oral suspension and 200 mg tablets Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age.Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing. Viramune 400 mg prolonged-release tablets Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children three years and above and able to swallow tablets (see section 4.2). Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used (see section 4.2). Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "07/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/10/1997", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/02/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "46", "first_published_date": "01/05/2018", "last_updated_date": "07/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/viramune" }, { "category": "Human", "name_of_medicine": "Neupro", "ema_product_number": "EMEA/H/C/000626", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000339937", "international_non_proprietary_name_common_name": "rotigotine", "active_substance": "rotigotine", "therapeutic_area_mesh": "Restless Legs Syndrome;Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BC09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Parkinson's disease: Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations). Restless-legs syndrome: Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma S.A.", "european_commission_decision_date": "07/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2005", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/02/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "09/11/2017", "last_updated_date": "07/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neupro" }, { "category": "Human", "name_of_medicine": "Kavigale", "ema_product_number": "EMEA/H/C/006291", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000337215", "international_non_proprietary_name_common_name": "sipavibart", "active_substance": "sipavibart", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BD09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kavigale is indicated for the pre-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kg and who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments.Kavigale should be used in accordance with official recommendations where available and based on information on the activity of sipavibart against presently circulating viral variants (see sections 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "07/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/01/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "13/12/2024", "last_updated_date": "07/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kavigale" }, { "category": "Human", "name_of_medicine": "Aerinaze", "ema_product_number": "EMEA/H/C/000772", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000335544", "international_non_proprietary_name_common_name": "desloratadine;pseudoephedrine", "active_substance": "desloratadine;pseudophedrine sulfate", "therapeutic_area_mesh": "Rhinitis, Allergic, Seasonal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R01BA52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Nasal preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "07/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/05/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/07/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "15/06/2018", "last_updated_date": "07/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aerinaze" }, { "category": "Human", "name_of_medicine": "Zokinvy", "ema_product_number": "EMEA/H/C/005271", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000269652", "international_non_proprietary_name_common_name": "lonafarnib", "active_substance": "Lonafarnib", "therapeutic_area_mesh": "Progeria;Laminopathies", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of Hutchinson-Gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous LMNA mutation with progerin-like protein accumulation or a homozygous or compound heterozygous ZMPSTE24 mutation.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "TMC Pharma (EU) Limited", "european_commission_decision_date": "20/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/07/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "01/08/2022", "last_updated_date": "07/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zokinvy" }, { "category": "Human", "name_of_medicine": "Keppra", "ema_product_number": "EMEA/H/C/000277", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000339920", "international_non_proprietary_name_common_name": "levetiracetam", "active_substance": "levetiracetam", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Keppra is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma SA", "european_commission_decision_date": "01/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/06/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/09/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "58", "first_published_date": "26/04/2018", "last_updated_date": "01/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/keppra" }, { "category": "Human", "name_of_medicine": "Ryzneuta", "ema_product_number": "EMEA/H/C/005828", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325073", "international_non_proprietary_name_common_name": "efbemalenograstim alfa", "active_substance": "efbemalenograstim alfa", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ryzneuta is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Evive Biotechnology Ireland Limited", "european_commission_decision_date": "01/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/01/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "25/01/2024", "last_updated_date": "01/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ryzneuta" }, { "category": "Human", "name_of_medicine": "Ilumira", "ema_product_number": "EMEA/H/C/006596", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "lutetium (177Lu) chloride", "active_substance": "lutetium (177Lu) chloride", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V10X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Therapeutic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ilumira is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Shine Europe B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/01/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/01/2026", "last_updated_date": "01/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ilumira" }, { "category": "Human", "name_of_medicine": "RoActemra", "ema_product_number": "EMEA/H/C/000955", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000261482", "international_non_proprietary_name_common_name": "tocilizumab", "active_substance": "tocilizumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Cytokine Release Syndrome;Giant Cell Arteritis;COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "RoActemra, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. \tIn these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. \tRoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.  RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients. RoActemra, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. \tIn these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.  \tRoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older. RoActemra, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. \tIn these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.  \tRoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "49", "first_published_date": "12/04/2018", "last_updated_date": "01/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/roactemra" }, { "category": "Human", "name_of_medicine": "Firazyr", "ema_product_number": "EMEA/H/C/000899", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000334728", "international_non_proprietary_name_common_name": "icatibant", "active_substance": "icatibant", "therapeutic_area_mesh": "Angioedemas, Hereditary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG", "european_commission_decision_date": "01/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/04/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/07/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "26/04/2018", "last_updated_date": "01/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/firazyr" }, { "category": "Human", "name_of_medicine": "Eliquis", "ema_product_number": "EMEA/H/C/002148", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319463", "international_non_proprietary_name_common_name": "apixaban", "active_substance": "apixaban", "therapeutic_area_mesh": "Arthroplasty;Venous Thromboembolism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AF02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb / Pfizer EEIG", "european_commission_decision_date": "01/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/03/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/05/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "40", "first_published_date": "03/08/2018", "last_updated_date": "01/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eliquis" }, { "category": "Human", "name_of_medicine": "Winrevair", "ema_product_number": "EMEA/H/C/005647", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000335114", "international_non_proprietary_name_common_name": "sotatercept", "active_substance": "sotatercept", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III and IV.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "24/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "28/06/2024", "last_updated_date": "01/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/winrevair" }, { "category": "Human", "name_of_medicine": "LysaKare", "ema_product_number": "EMEA/H/C/004541", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000335864", "international_non_proprietary_name_common_name": "arginine;lysine", "active_substance": "L-arginine hydrochloride;L-lysine hydrochloride", "therapeutic_area_mesh": "Radiation Injuries", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AF11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Detoxifying agents for antineoplastic treatment", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "LysaKare is indicated for reduction of renal radiation exposure during Peptide-Receptor Radionuclide Therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Advanced Accelerator Applications", "european_commission_decision_date": "31/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/05/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/07/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "30/07/2019", "last_updated_date": "01/04/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lysakare" }, { "category": "Human", "name_of_medicine": "Elfabrio", "ema_product_number": "EMEA/H/C/005618", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0007", "international_non_proprietary_name_common_name": "pegunigalsidase alfa", "active_substance": "pegunigalsidase alfa", "therapeutic_area_mesh": "Fabry Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB20", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/05/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "21/02/2023", "last_updated_date": "31/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elfabrio" }, { "category": "Human", "name_of_medicine": "Topotecan Hospira", "ema_product_number": "EMEA/H/C/001192", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000339309", "international_non_proprietary_name_common_name": "topotecan", "active_substance": "topotecan", "therapeutic_area_mesh": "Uterine Cervical Neoplasms;Small Cell Lung Carcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "31/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/03/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/06/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "13/04/2018", "last_updated_date": "31/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/topotecan-hospira" }, { "category": "Human", "name_of_medicine": "Vaxelis", "ema_product_number": "EMEA/H/C/003982", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000301874", "international_non_proprietary_name_common_name": "diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)", "active_substance": "Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3;hepatitis B surface antigen produced in yeast cells;poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein.", "therapeutic_area_mesh": "Meningitis, Haemophilus;Poliomyelitis;Tetanus;Diphtheria;Whooping Cough;Hepatitis B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07CA09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of Vaxelis should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "MCM Vaccine B.V.", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/12/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/02/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "06/04/2018", "last_updated_date": "31/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vaxelis" }, { "category": "Human", "name_of_medicine": "Zoledronic acid Mylan", "ema_product_number": "EMEA/H/C/002482", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000339225", "international_non_proprietary_name_common_name": "zoledronic acid", "active_substance": "zoledronic acid", "therapeutic_area_mesh": "Fractures, Bone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone; treatment of adult patients with tumour-induced hypercalcaemia (TIH).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "31/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "11/09/2017", "last_updated_date": "31/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zoledronic-acid-mylan" }, { "category": "Human", "name_of_medicine": "Hepcludex", "ema_product_number": "EMEA/H/C/004854", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320140", "international_non_proprietary_name_common_name": "bulevirtide", "active_substance": "bulevirtide acetate", "therapeutic_area_mesh": "Hepatitis D, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05A", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult and paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/07/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "12/08/2020", "last_updated_date": "31/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hepcludex" }, { "category": "Human", "name_of_medicine": "Alecensa", "ema_product_number": "EMEA/H/C/004164", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000313101", "international_non_proprietary_name_common_name": "alectinib", "active_substance": "alectinib hydrochloride", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01ED03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adjuvant treatment of resected non small cell lung cancer (NSCLC) Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK positive NSCLC at high risk of recurrence (see section 5.1 for selection criteria).Treatment of advanced NSCLCAlecensa as monotherapy is indicated for the first line treatment of adult patients with ALK positive advanced NSCLC.Alecensa as monotherapy is indicated for the treatment of adult patients with ALK positive advanced NSCLC previously treated with crizotinib.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "29/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/02/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "09/08/2018", "last_updated_date": "31/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alecensa" }, { "category": "Human", "name_of_medicine": "Cinacalcet Accordpharma", "ema_product_number": "EMEA/H/C/005236", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000338878", "international_non_proprietary_name_common_name": "cinacalcet", "active_substance": "cinacalcet hydrochloride", "therapeutic_area_mesh": "Hyperparathyroidism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05BX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Secondary hyperparathyroidism AdultsTreatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric populationTreatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4). Cinacalcet Accordpharma may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1). Parathyroid carcinoma and primary hyperparathyroidism in adults Reduction of hypercalcaemia in adult patients with: parathyroid carcinoma. primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "31/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/04/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "15/04/2020", "last_updated_date": "31/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cinacalcet-accordpharma" }, { "category": "Human", "name_of_medicine": "Brilique", "ema_product_number": "EMEA/H/C/001241", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000302037", "international_non_proprietary_name_common_name": "ticagrelor", "active_substance": "ticagrelor", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Acute Coronary Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC24", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Brilique, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) or a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event Brilique, co-administered with acetyl salicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing an atherothrombotic event.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "19/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/12/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "18/05/2017", "last_updated_date": "31/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/brilique" }, { "category": "Human", "name_of_medicine": "Finlee", "ema_product_number": "EMEA/H/C/005885", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000296502", "international_non_proprietary_name_common_name": "dabrafenib", "active_substance": "dabrafenib mesilate", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Low-grade glioma Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. High-grade glioma Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "25/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "05/12/2023", "last_updated_date": "30/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/finlee" }, { "category": "Human", "name_of_medicine": "Alyftrek", "ema_product_number": "EMEA/H/C/006382", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000338822", "international_non_proprietary_name_common_name": "deutivacaftor / tezacaftor / vanzacaftor", "active_substance": "deutivacaftor;tezacaftor;vanzacaftor calcium dihydrate", "therapeutic_area_mesh": "Cystic Fibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R07AX33", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other respiratory system products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Alyftrek tablets are indicated for the treatment of cystic fibrosis (CF) in people aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (see sections 4.2 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vertex Pharmaceuticals (Ireland) Limited", "european_commission_decision_date": "30/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "25/04/2025", "last_updated_date": "30/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alyftrek" }, { "category": "Human", "name_of_medicine": "Glyxambi", "ema_product_number": "EMEA/H/C/003833", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000332881", "international_non_proprietary_name_common_name": "empagliflozin;linagliptin", "active_substance": "empagliflozin;linagliptin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD19", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control; when already being treated with the free combination of empagliflozin and linagliptin.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "28/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/11/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "03/08/2018", "last_updated_date": "30/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/glyxambi" }, { "category": "Human", "name_of_medicine": "Increlex", "ema_product_number": "EMEA/H/C/000704", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000337918", "international_non_proprietary_name_common_name": "mecasermin", "active_substance": "Mecasermin", "therapeutic_area_mesh": "Laron Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01AC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary IGFD). Severe primary IGFD is defined by: height standard deviation score ? -3.0 and; basal insulin-like growth factor-1 (IGF-1) levels below the 2.5th percentile for age and gender and; growth hormone (GH) sufficiency; exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Severe primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signalling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Esteve Pharmaceuticals, S.A.", "european_commission_decision_date": "30/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/08/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "14/09/2017", "last_updated_date": "30/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/increlex" }, { "category": "Human", "name_of_medicine": "Flucelvax", "ema_product_number": "EMEA/H/C/006532", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000332852", "international_non_proprietary_name_common_name": "influenza vaccine (surface antigen, inactivated, prepared in cell cultures)", "active_substance": "A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022 CVR-167) / A/District of Columbia/27/2023 (H3N2)-like strain (A/Victoria/800/2024 CVR-289) / B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021)", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in adults and children from 6 months of age. Flucelvax should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Seqirus Netherlands B.V.", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "18/10/2024", "last_updated_date": "30/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/flucelvax" }, { "category": "Human", "name_of_medicine": "Wegovy", "ema_product_number": "EMEA/H/C/005422", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000334532", "international_non_proprietary_name_common_name": "semaglutide", "active_substance": "semaglutide", "therapeutic_area_mesh": "Obesity;Overweight", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiobesity preparations, excl. diet products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥30 kg/m2 (obesity), or ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. For trial results with respect to cardiovascular risk reduction and populations studied, see section 5.1. Adolescents (≥12 years) Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with obesity* and body weight above 60 kg. Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose. *Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1 in 4.1 of SmPC). Table 1 BMI cut-off points for obesity (≥95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "30/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/11/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/01/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "11/11/2021", "last_updated_date": "30/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy" }, { "category": "Human", "name_of_medicine": "Wakix", "ema_product_number": "EMEA/H/C/002616", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PASS/0000281790", "international_non_proprietary_name_common_name": "pitolisant", "active_substance": "pitolisant", "therapeutic_area_mesh": "Narcolepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bioprojet Pharma", "european_commission_decision_date": "19/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/03/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "22/02/2018", "last_updated_date": "27/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/wakix" }, { "category": "Human", "name_of_medicine": "Atazanavir Krka", "ema_product_number": "EMEA/H/C/004859", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000273939", "international_non_proprietary_name_common_name": "atazanavir", "active_substance": "atazanavir (as sulfate)", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Atazanavir Krka capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products. Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (? 4 PI mutations). The choice of Atazanavir Krka in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "03/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/01/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/03/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "23/02/2026", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "15/05/2019", "last_updated_date": "27/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/atazanavir-krka" }, { "category": "Human", "name_of_medicine": "Duvyzat", "ema_product_number": "EMEA/H/C/006079", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282569", "international_non_proprietary_name_common_name": "givinostat", "active_substance": "givinostat hydrochloride monohydrate", "therapeutic_area_mesh": "Muscular Dystrophy, Duchenne", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Duvyzat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Italfarmaco S.p.A.", "european_commission_decision_date": "17/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/04/2025", "last_updated_date": "27/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duvyzat" }, { "category": "Human", "name_of_medicine": "Ziextenzo", "ema_product_number": "EMEA/H/C/004802", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0031", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "30/11/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "21/09/2018", "last_updated_date": "27/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo" }, { "category": "Human", "name_of_medicine": "Vevzuo", "ema_product_number": "EMEA/H/C/006534", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000338067", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Neoplasms, Bone Tissue;Giant Cell Tumor of Bone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "27/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "25/04/2025", "last_updated_date": "27/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vevzuo" }, { "category": "Human", "name_of_medicine": "Adstiladrin", "ema_product_number": "EMEA/H/C/005856", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "nadofaragene firadenovec", "active_substance": "nadofaragene firadenovec", "therapeutic_area_mesh": "Non-Muscle Invasive Bladder Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XL10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with high-grade (HG), Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ferring Pharmaceuticals A/S", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/03/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adstiladrin" }, { "category": "Human", "name_of_medicine": "Imdylltra", "ema_product_number": "EMEA/H/C/006451", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tarlatamab", "active_substance": "tarlatamab", "therapeutic_area_mesh": "Small Cell Lung Carcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX33", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of extensive-stage small cell lung cancer", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/03/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imdylltra" }, { "category": "Human", "name_of_medicine": "Bopediat", "ema_product_number": "EMEA/H/C/006617", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "furosemide", "active_substance": "furosemide", "therapeutic_area_mesh": "Edema, Cardiac;Edema;Hypertension;Renal Insufficiency, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C03CA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "High-ceiling diuretics;Sulfonamides, plain", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of all conditions requiring diuresis due to mechanical obstruction or venous insufficiency", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Proveca Pharma Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/03/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bopediat" }, { "category": "Human", "name_of_medicine": "Blarcamesine Anavex", "ema_product_number": "EMEA/H/C/006475", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "blarcamesine", "active_substance": "blarcamesine hydrochloride", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06D", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Alzheimer’s disease and dementia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/12/2025", "withdrawal_of_application_date": "25/03/2026", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/12/2025", "last_updated_date": "27/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/blarcamesine-anavex" }, { "category": "Human", "name_of_medicine": "Kisplyx", "ema_product_number": "EMEA/H/C/004224", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000328217", "international_non_proprietary_name_common_name": "lenvatinib", "active_substance": "lenvatinib mesilate", "therapeutic_area_mesh": "Carcinoma, Renal Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE29", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC): in combination with pembrolizumab, as first-line treatment (see section 5.1). in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eisai GmbH", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/08/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "21/06/2018", "last_updated_date": "26/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kisplyx" }, { "category": "Human", "name_of_medicine": "Lenvima", "ema_product_number": "EMEA/H/C/003727", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000328217", "international_non_proprietary_name_common_name": "lenvatinib", "active_substance": "lenvatinib mesilate", "therapeutic_area_mesh": "Thyroid Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lenvima is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Lenvima is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eisai GmbH", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/05/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "21/06/2018", "last_updated_date": "26/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lenvima" }, { "category": "Human", "name_of_medicine": "Lazcluze", "ema_product_number": "EMEA/H/C/006074", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315717", "international_non_proprietary_name_common_name": "lazertinib", "active_substance": "lazertinib mesilate monohydrate", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EB09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lazcluze in combination with amivantamab is indicated for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen Cilag International NV", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/01/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "18/07/2025", "last_updated_date": "26/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lazcluze" }, { "category": "Human", "name_of_medicine": "Axumin", "ema_product_number": "EMEA/H/C/004197", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000337203", "international_non_proprietary_name_common_name": "fluciclovine (18F)", "active_substance": "fluciclovine (18F)", "therapeutic_area_mesh": "Prostatic Neoplasms;Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09IX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Axumin is indicated for Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Blue Earth Diagnostics Ireland Ltd", "european_commission_decision_date": "26/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/03/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/05/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "11/06/2018", "last_updated_date": "26/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/axumin" }, { "category": "Human", "name_of_medicine": "Xtandi", "ema_product_number": "EMEA/H/C/002639", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000313098", "international_non_proprietary_name_common_name": "enzalutamide", "active_substance": "enzalutamide", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma Europe B.V.", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/06/2013", "refusal_of_marketing_authorisation_date": "26/04/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "08/02/2018", "last_updated_date": "26/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xtandi" }, { "category": "Human", "name_of_medicine": "Orserdu", "ema_product_number": "EMEA/H/C/005898", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000338142", "international_non_proprietary_name_common_name": "elacestrant", "active_substance": "elacestrant", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stemline Therapeutics B.V.", "european_commission_decision_date": "25/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "18/07/2023", "last_updated_date": "25/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orserdu" }, { "category": "Human", "name_of_medicine": "Lyrica", "ema_product_number": "EMEA/H/C/000546", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000334503", "international_non_proprietary_name_common_name": "pregabalin", "active_substance": "pregabalin", "therapeutic_area_mesh": "Epilepsy;Anxiety Disorders;Neuralgia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02BF02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics;Other analgesics and antipyretics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Neuropathic pain Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorder Lyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Upjohn EESV", "european_commission_decision_date": "25/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/07/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "72", "first_published_date": "16/11/2017", "last_updated_date": "25/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lyrica" }, { "category": "Human", "name_of_medicine": "SomaKit TOC", "ema_product_number": "EMEA/H/C/004140", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000281217", "international_non_proprietary_name_common_name": "edotreotide", "active_substance": "edotreotide", "therapeutic_area_mesh": "Neuroendocrine Tumors;Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09IX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastro-enteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Advanced Accelerator Applications", "european_commission_decision_date": "19/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/12/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "12/06/2017", "last_updated_date": "25/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/somakit-toc" }, { "category": "Human", "name_of_medicine": "Zirabev", "ema_product_number": "EMEA/H/C/004697", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000337578", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Colorectal Neoplasms;Breast Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Uterine Cervical Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status. Zirabev, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Zirabev in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Zirabev, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "25/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/12/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "11/12/2018", "last_updated_date": "25/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zirabev" }, { "category": "Human", "name_of_medicine": "Bemfola", "ema_product_number": "EMEA/H/C/002615", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325945", "international_non_proprietary_name_common_name": "follitropin alfa", "active_substance": "follitropin alfa", "therapeutic_area_mesh": "Anovulation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03GA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "In adult women: anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate; stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT); follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l. In adult men: follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "23/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/01/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "15/05/2018", "last_updated_date": "25/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bemfola" }, { "category": "Human", "name_of_medicine": "Tepezza", "ema_product_number": "EMEA/H/C/006396", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000337101", "international_non_proprietary_name_common_name": "teprotumumab", "active_substance": "teprotumumab", "therapeutic_area_mesh": "Graves Ophthalmopathy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AG13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants;Monoclonal antibodies", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of moderate to severe thyroid eye disease (TED).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "25/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/04/2025", "last_updated_date": "25/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tepezza" }, { "category": "Human", "name_of_medicine": "Trabectedin Accord", "ema_product_number": "EMEA/H/C/006433", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000333307", "international_non_proprietary_name_common_name": "trabectedin", "active_substance": "trabectedin", "therapeutic_area_mesh": "Sarcoma;Ovarian Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trabectedin Accord is indicated for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. Trabectedin Accord in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "24/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/02/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/04/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "28/02/2025", "last_updated_date": "25/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trabectedin-accord" }, { "category": "Human", "name_of_medicine": "Bortezomib Accord", "ema_product_number": "EMEA/H/C/003984", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000338604", "international_non_proprietary_name_common_name": "bortezomib", "active_substance": "bortezomib", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX32", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bortezomib Accord as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib Accord in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high?dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Accord in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high?dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Accord in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "24/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/07/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "28/05/2018", "last_updated_date": "25/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bortezomib-accord" }, { "category": "Human", "name_of_medicine": "Sylvant", "ema_product_number": "EMEA/H/C/003708", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000337997", "international_non_proprietary_name_common_name": "siltuximab", "active_substance": "siltuximab", "therapeutic_area_mesh": "Giant Lymph Node Hyperplasia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sylvant is indicated for the treatment of adult patients with multicentric Castleman’s disease (MCD who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.", "accelerated_assessment": "Yes", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Netherlands B.V.", "european_commission_decision_date": "24/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/03/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/05/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "12/04/2018", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sylvant" }, { "category": "Human", "name_of_medicine": "Stivarga", "ema_product_number": "EMEA/H/C/002573", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000312922", "international_non_proprietary_name_common_name": "regorafenib", "active_substance": "regorafenib", "therapeutic_area_mesh": "Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Stivarga is indicated as monotherapy for the treatment of adult patients with: metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy; unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib; hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer Pharma AG", "european_commission_decision_date": "26/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "25/06/2018", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/stivarga" }, { "category": "Human", "name_of_medicine": "Kanuma", "ema_product_number": "EMEA/H/C/004004", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000326194", "international_non_proprietary_name_common_name": "sebelipase alfa", "active_substance": "sebelipase alfa", "therapeutic_area_mesh": "Lipid Metabolism, Inborn Errors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kanuma is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) deficiency.", "accelerated_assessment": "Yes", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Alexion Europe SAS", "european_commission_decision_date": "24/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/08/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "12/10/2017", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kanuma" }, { "category": "Human", "name_of_medicine": "MenQuadfi", "ema_product_number": "EMEA/H/C/005084", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000338324", "international_non_proprietary_name_common_name": "meningococcal group A, C, W-135 and Y conjugate vaccine", "active_substance": "Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid", "therapeutic_area_mesh": "Meningitis, Meningococcal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AH08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "MenQuadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. The use of this vaccine should be in accordance with available official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "24/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/09/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/11/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "27/11/2020", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/menquadfi" }, { "category": "Human", "name_of_medicine": "Kadcyla", "ema_product_number": "EMEA/H/C/002389", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000302277", "international_non_proprietary_name_common_name": "trastuzumab emtansine", "active_substance": "trastuzumab emtansine", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Early Breast Cancer (EBC) Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. Metastatic Breast Cancer (MBC) Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: Received prior therapy for locally advanced or metastatic disease, or Developed disease recurrence during or within six months of completing adjuvant therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "19/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "19/12/2013", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kadcyla" }, { "category": "Human", "name_of_medicine": "Grasustek", "ema_product_number": "EMEA/H/C/004556", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000338145", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Juta Pharma GmbH", "european_commission_decision_date": "24/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "28/06/2019", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/grasustek" }, { "category": "Human", "name_of_medicine": "Qaialdo", "ema_product_number": "EMEA/H/C/005535", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000333112", "international_non_proprietary_name_common_name": "spironolactone", "active_substance": "spironolactone", "therapeutic_area_mesh": "Edema;Heart Failure;Liver Cirrhosis;Ascites;Nephrotic Syndrome;Hyperaldosteronism;Essential Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C03DA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives and diuretics in combination", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2). ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lipomed GmbH", "european_commission_decision_date": "24/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "25/07/2023", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qaialdo" }, { "category": "Human", "name_of_medicine": "Vafseo", "ema_product_number": "EMEA/H/C/005131", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000337598", "international_non_proprietary_name_common_name": "vadadustat", "active_substance": "vadadustat", "therapeutic_area_mesh": "Renal Insufficiency, Chronic;Anemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Medice Arzneimittel Pütter GmbH & Co. KG", "european_commission_decision_date": "24/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/04/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "31/05/2023", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vafseo" }, { "category": "Human", "name_of_medicine": "Artesunate Amivas", "ema_product_number": "EMEA/H/C/005550", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325106", "international_non_proprietary_name_common_name": "artesunate", "active_substance": "artesunate", "therapeutic_area_mesh": "Malaria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "P01BE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiprotozoals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children. Consideration should be given to official guidance on the appropriate use of antimalarial agents.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amivas Ireland Ltd", "european_commission_decision_date": "24/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/08/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "04/01/2022", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/artesunate-amivas" }, { "category": "Human", "name_of_medicine": "Roclanda", "ema_product_number": "EMEA/H/C/005107", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315343", "international_non_proprietary_name_common_name": "latanoprost / netarsudil", "active_substance": "Latanoprost;netarsudil mesilate", "therapeutic_area_mesh": "Glaucoma, Open-Angle;Ocular Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01EE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Roclanda is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Santen Oy", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/11/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/01/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "21/01/2021", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/roclanda" }, { "category": "Human", "name_of_medicine": "Jardiance", "ema_product_number": "EMEA/H/C/002677", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000333055", "international_non_proprietary_name_common_name": "empagliflozin", "active_substance": "empagliflozin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2;Heart Failure;Renal Insufficiency, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BK03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Type 2 diabetes mellitus Jardiance is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance in addition to other medicinal products for the treatment of diabetes For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  Chronic kidney disease Jardiance is indicated in adults for the treatment of chronic kidney disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "24/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/03/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/05/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "31/05/2018", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jardiance" }, { "category": "Human", "name_of_medicine": "Velphoro", "ema_product_number": "EMEA/H/C/002705", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315843", "international_non_proprietary_name_common_name": "sucroferric oxyhydroxide", "active_substance": "sucroferric oxyhydroxide", "therapeutic_area_mesh": "Hyperphosphatemia;Renal Dialysis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AE05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of hyperkalemia and hyperphosphatemia", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). Velphoro is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with CKD stages 4-5 (defined by a glomerular filtration rate <30 mL/min/1.73 m²) or with CKD on dialysis. Velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vifor Fresenius Medical Care Renal Pharma France", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/06/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "20/02/2018", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/velphoro" }, { "category": "Human", "name_of_medicine": "Zynyz", "ema_product_number": "EMEA/H/C/006194", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000247788", "international_non_proprietary_name_common_name": "retifanlimab", "active_substance": "retifanlimab", "therapeutic_area_mesh": "Carcinoma, Merkel Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FF10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Squamous cell carcinoma of the anal canal (SCAC) Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). Merkel cell carcinoma (MCC)  Zynyz is indicated as monotherapy for the first line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Incyte Biosciences Distribution B.V.", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "23/02/2024", "last_updated_date": "24/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zynyz" }, { "category": "Human", "name_of_medicine": "Shingrix", "ema_product_number": "EMEA/H/C/004336", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315862", "international_non_proprietary_name_common_name": "herpes zoster vaccine (recombinant, adjuvanted)", "active_substance": "recombinant varicella zoster virus glycoprotein E", "therapeutic_area_mesh": "Herpes Zoster", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BK03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in: adults 50 years of age or older; adults 18 years of age or older at increased risk of HZ. The use of Shingrix should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "21/03/2018", "last_updated_date": "23/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/shingrix" }, { "category": "Human", "name_of_medicine": "Sondelbay", "ema_product_number": "EMEA/H/C/005827", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000335895", "international_non_proprietary_name_common_name": "teriparatide", "active_substance": "teriparatide", "therapeutic_area_mesh": "Osteoporosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sondelbay is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "23/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/01/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/03/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "16/06/2022", "last_updated_date": "23/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sondelbay" }, { "category": "Human", "name_of_medicine": "Vaborem", "ema_product_number": "EMEA/H/C/004669", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315162", "international_non_proprietary_name_common_name": "meropenem;vaborbactam", "active_substance": "meropenem trihydrate;vaborbactam", "therapeutic_area_mesh": "Urinary Tract Infections;Bacteremia;Bacterial Infections;Respiratory Tract Infections;Pneumonia;Pneumonia, Ventilator-Associated", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01DH", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vaborem is indicated for the treatment of the following infections in adults: Complicated urinary tract infection (cUTI), including pyelonephritis Complicated intra-abdominal infection (cIAI) Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Vaborem is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Menarini International Operations Luxembourg S.A.", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "18/12/2018", "last_updated_date": "23/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vaborem" }, { "category": "Human", "name_of_medicine": "Tremfya", "ema_product_number": "EMEA/H/C/004271", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000321306", "international_non_proprietary_name_common_name": "guselkumab", "active_substance": "", "therapeutic_area_mesh": "Psoriasis;Crohn Disease;Colitis, Ulcerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adult plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.  Psoriatic arthritisTremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.Ulcerative colitisTremfya is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment.Crohn’s diseaseTremfya is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "23/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "10/11/2017", "last_updated_date": "23/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya" }, { "category": "Human", "name_of_medicine": "Opzelura", "ema_product_number": "EMEA/H/C/005843", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296040", "international_non_proprietary_name_common_name": "ruxolitinib", "active_substance": "ruxolitinib phosphate", "therapeutic_area_mesh": "Vitiligo", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D11AH", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other dermatological preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Incyte Biosciences Distribution B.V.", "european_commission_decision_date": "26/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "22/02/2023", "last_updated_date": "23/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opzelura" }, { "category": "Human", "name_of_medicine": "Waylivra", "ema_product_number": "EMEA/H/C/004538", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000280220", "international_non_proprietary_name_common_name": "volanesorsen", "active_substance": "volanesorsen sodium", "therapeutic_area_mesh": "Hyperlipoproteinemia Type I", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AX18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Waylivra is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Akcea Therapeutics Ireland Limited", "european_commission_decision_date": "11/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/02/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/05/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "20/05/2019", "last_updated_date": "23/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/waylivra" }, { "category": "Human", "name_of_medicine": "Rxulti", "ema_product_number": "EMEA/H/C/003841", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000307490", "international_non_proprietary_name_common_name": "brexpiprazole", "active_substance": "brexpiprazole", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rxulti is indicated for the treatment of schizophrenia in adult and adolescents aged 13 years and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Otsuka Pharmaceutical Netherlands B.V.", "european_commission_decision_date": "15/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "26/11/2018", "last_updated_date": "23/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rxulti" }, { "category": "Human", "name_of_medicine": "Apremilast Accord", "ema_product_number": "EMEA/H/C/006208", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000337482", "international_non_proprietary_name_common_name": "apremilast", "active_substance": "apremilast", "therapeutic_area_mesh": "Arthritis, Psoriatic;Psoriasis;Behcet Syndrome;Oral Ulcer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA32", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Psoriatic arthritis Apremilast Accord, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1).Psoriasis Apremilast Accord is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).Behçet’s disease Apremilast Accord is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "20/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "23/02/2024", "last_updated_date": "20/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/apremilast-accord" }, { "category": "Veterinary", "name_of_medicine": "Cunitraxx", "ema_product_number": "EMEA/V/C/006595", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fenbendazole", "active_substance": "fenbendazole", "therapeutic_area_mesh": "", "species_veterinary": "Rabbits", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QP52AC13", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anthelmintics", "therapeutic_indication": "Treatment and control of protozoan parasites in rabbits infected with Encephalitozoon cuniculi.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Avimedical B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "23/04/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/03/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cunitraxx" }, { "category": "Human", "name_of_medicine": "Ebglyss", "ema_product_number": "EMEA/H/C/005894", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000320367", "international_non_proprietary_name_common_name": "lebrikizumab", "active_substance": "Lebrikizumab", "therapeutic_area_mesh": "Dermatitis, Atopic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D11AH10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other dermatological preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Almirall, S.A.", "european_commission_decision_date": "14/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/11/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "21/11/2023", "last_updated_date": "20/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ebglyss" }, { "category": "Human", "name_of_medicine": "Adcetris", "ema_product_number": "EMEA/H/C/002455", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323310", "international_non_proprietary_name_common_name": "brentuximab vedotin", "active_substance": "Brentuximab vedotin", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin;Hodgkin Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hodgkin lymphomaAdcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).Adcetris is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD).Adcetris is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT).Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):- following ASCT, or- following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.Systemic anaplastic large cell lymphomaAdcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). Adcetris is indicated for the treatment of adult patients with relapsed or refractory sALCL.Cutaneous T-cell lymphomaAdcetris is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "18/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/07/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/10/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "38", "first_published_date": "25/07/2018", "last_updated_date": "20/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adcetris" }, { "category": "Human", "name_of_medicine": "Evfraxy", "ema_product_number": "EMEA/H/C/006526", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000322525", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Evfraxy significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Evfraxy significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "18/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "25/04/2025", "last_updated_date": "20/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evfraxy" }, { "category": "Human", "name_of_medicine": "SonoVue", "ema_product_number": "EMEA/H/C/000303", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000337224", "international_non_proprietary_name_common_name": "sulphur hexafluoride", "active_substance": "sulphur hexafluoride", "therapeutic_area_mesh": "Ultrasonography;Echocardiography", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V08DA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Contrast media", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal to noise ratio. SonoVue should only be used in patients where study without contrast enhancement is inconclusive. Echocardiography SonoVue is a transpulmonary echocardiographic contrast agent for use in adult patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation. Doppler of macrovasculature SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries in adult patients by improving the Doppler signal to noise ratio. SonoVue increases the quality of the Doppler flow image and the duration of clinically useful signal enhancement in portal vein assessment in adult patients. Doppler of microvasculature SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography in adult patients leading to more specific lesion characterisation. Ultrasonography of excretory urinary tract SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux. For the limitation in the interpretation of a negative urosonography.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bracco International B.V.", "european_commission_decision_date": "18/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "26/04/2018", "last_updated_date": "20/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sonovue" }, { "category": "Human", "name_of_medicine": "Xgeva", "ema_product_number": "EMEA/H/C/002173", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000280127", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Giant Cell Tumor of Bone;Neoplasms, Bone Tissue", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1). Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "29/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/07/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "27/03/2018", "last_updated_date": "19/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xgeva" }, { "category": "Human", "name_of_medicine": "Vargatef", "ema_product_number": "EMEA/H/C/002569", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2701", "international_non_proprietary_name_common_name": "nintedanib", "active_substance": "nintedanib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE3", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "04/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/09/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/11/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "26/07/2018", "last_updated_date": "19/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vargatef" }, { "category": "Human", "name_of_medicine": "Osenvelt", "ema_product_number": "EMEA/H/C/006157", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296328", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Giant Cell Tumor of Bone;Neoplasms, Bone Tissue", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "13/12/2024", "last_updated_date": "19/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/osenvelt" }, { "category": "Human", "name_of_medicine": "Libmyris", "ema_product_number": "EMEA/H/C/005947", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000335580", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Psoriasis;Hidradenitis Suppurativa;Crohn Disease;Colitis, Ulcerative;Uveitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis \t\t\tLibmyris in combination with methotrexate, is indicated for: \t\t\t- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate. \t\t\t- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis \t\t\tPolyarticular juvenile idiopathic arthritis \t\t\tLibmyris in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more DMARD. Libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis \t\t\tLibmyris is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Axial spondyloarthritis \t\t\tAnkylosing spondylitis (AS) \t\t\tLibmyris is indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS \t\t\tLibmyris is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis \t\t\tLibmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis \t\t\tLibmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis \t\t\tLibmyris is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) \t\t\tLibmyris is indicated for the treatment of active moderate to severe HS (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease \t\t\tLibmyris is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease \t\t\tLibmyris is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis \t\t\tLibmyris is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis \t\t\tLibmyris is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis \t\t\tLibmyris is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis \t\t\tLibmyris is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stada Arzneimittel AG", "european_commission_decision_date": "19/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/11/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "14/09/2021", "last_updated_date": "19/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/libmyris" }, { "category": "Human", "name_of_medicine": "Aerius", "ema_product_number": "EMEA/H/C/000313", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000312765", "international_non_proprietary_name_common_name": "desloratadine", "active_substance": "desloratadine", "therapeutic_area_mesh": "Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R06AX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihistamines for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aerius is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "26/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/09/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/01/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "53", "first_published_date": "29/06/2018", "last_updated_date": "19/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aerius" }, { "category": "Human", "name_of_medicine": "Neoclarityn", "ema_product_number": "EMEA/H/C/000314", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000312765", "international_non_proprietary_name_common_name": "desloratadine", "active_substance": "desloratadine", "therapeutic_area_mesh": "Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R06AX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihistamines for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Neoclarityn is indicated for the relief of symptoms associated with: allergic rhinitis urticaria", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "26/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/09/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/01/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "49", "first_published_date": "15/06/2018", "last_updated_date": "19/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neoclarityn" }, { "category": "Human", "name_of_medicine": "Kaftrio", "ema_product_number": "EMEA/H/C/005269", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000333715", "international_non_proprietary_name_common_name": "ivacaftor;tezacaftor;elexacaftor", "active_substance": "ivacaftor;tezacaftor;elexacaftor", "therapeutic_area_mesh": "Cystic Fibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R07AX32", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other respiratory system products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kaftrio tablets are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Kaftrio granules are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vertex Pharmaceuticals (Ireland) Limited", "european_commission_decision_date": "18/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/08/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "21/08/2020", "last_updated_date": "19/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kaftrio" }, { "category": "Human", "name_of_medicine": "Hympavzi", "ema_product_number": "EMEA/H/C/006240", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000334711", "international_non_proprietary_name_common_name": "marstacimab", "active_substance": "marstacimab", "therapeutic_area_mesh": "Hemophilia A;Hemophilia B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BX11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older, weighing at least 35 kg, with: severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII inhibitors, or severe haemophilia B (congenital factor IX deficiency, FIX < 1%) without factor IX inhibitors.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "18/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/11/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "20/09/2024", "last_updated_date": "19/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hympavzi" }, { "category": "Human", "name_of_medicine": "Lynparza", "ema_product_number": "EMEA/H/C/003726", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296305", "international_non_proprietary_name_common_name": "olaparib", "active_substance": "olaparib", "therapeutic_area_mesh": "Ovarian Neoplasms;Breast Neoplasms;Pancreatic Neoplasms;Prostatic Neoplasms, Castration-Resistant", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XK01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ovarian cancer Lynparza is indicated as monotherapy for the: maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. Lynparza in combination with bevacizumab is indicated for the: maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5.1). Breast cancer Lynparza is indicated as: monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1). monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. Adenocarcinoma of the pancreas Lynparza is indicated as: monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. Prostate cancer Lynparza is indicated as: monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1). Endometrial cancer Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/12/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "08/05/2018", "last_updated_date": "19/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza" }, { "category": "Human", "name_of_medicine": "Kostaive", "ema_product_number": "EMEA/H/C/006207", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000284897", "international_non_proprietary_name_common_name": "zapomeran", "active_substance": "COVID-19 sa-mRNA Vaccine", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BN01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Covid-19 vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kostaive is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Seqirus Netherlands B.V.", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "26/02/2025", "last_updated_date": "19/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kostaive" }, { "category": "Human", "name_of_medicine": "Deltyba", "ema_product_number": "EMEA/H/C/002552", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000293774", "international_non_proprietary_name_common_name": "delamanid", "active_substance": "Delamanid", "therapeutic_area_mesh": "Tuberculosis, Multidrug-Resistant", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J04AK06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycobacterials", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Otsuka Novel Products GmbH", "european_commission_decision_date": "20/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/11/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/04/2014", "refusal_of_marketing_authorisation_date": "25/07/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "11/06/2018", "last_updated_date": "18/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/deltyba" }, { "category": "Human", "name_of_medicine": "Strensiq", "ema_product_number": "EMEA/H/C/003794", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "S/0000293951", "international_non_proprietary_name_common_name": "asfotase alfa", "active_substance": "asfotase alfa", "therapeutic_area_mesh": "Hypophosphatasia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Alexion Europe SAS", "european_commission_decision_date": "16/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/06/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/08/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "03/05/2018", "last_updated_date": "18/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/strensiq" }, { "category": "Human", "name_of_medicine": "Cegfila (previously Pegfilgrastim Mundipharma)", "ema_product_number": "EMEA/H/C/005312", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325838", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mundipharma Corporation (Ireland) Limited", "european_commission_decision_date": "17/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/12/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "20/12/2019", "last_updated_date": "18/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cegfila" }, { "category": "Human", "name_of_medicine": "Pelmeg", "ema_product_number": "EMEA/H/C/004700", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325838", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "To reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mundipharma Corporation (Ireland) Limited", "european_commission_decision_date": "17/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "21/09/2018", "last_updated_date": "18/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg" }, { "category": "Human", "name_of_medicine": "Gohibic", "ema_product_number": "EMEA/H/C/006123", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000332043", "international_non_proprietary_name_common_name": "vilobelimab", "active_substance": "vilobelimab", "therapeutic_area_mesh": "Respiratory Distress Syndrome, Adult;COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AJ10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants, Complement inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Gohibic is indicated for the treatment of adult patients with SARS-CoV2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of Standard of Care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "InflaRx GmbH", "european_commission_decision_date": "17/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/01/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "15/11/2024", "last_updated_date": "17/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gohibic" }, { "category": "Human", "name_of_medicine": "Gazyvaro", "ema_product_number": "EMEA/H/C/002799", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000313033", "international_non_proprietary_name_common_name": "obinutuzumab", "active_substance": "obinutuzumab", "therapeutic_area_mesh": "Leukemia, Lymphocytic, Chronic, B-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Chronic lymphocytic leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy.  Follicular Lymphoma (FL)  Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.   Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.  Lupus nephritis (LN) Gazyvaro in combination with mycophenolate mofetil (MMF) is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN). ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/07/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "06/04/2018", "last_updated_date": "17/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gazyvaro" }, { "category": "Human", "name_of_medicine": "Daybu", "ema_product_number": "EMEA/H/C/006482", "medicine_status": "Opinion under re-examination", "opinion_status": "Negative", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "trofinetide", "active_substance": "trofinetide", "therapeutic_area_mesh": "Rett Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Rett syndrome in adults and paediatric patients 2 years of age and older", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Acadia Pharmaceuticals B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "17/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/daybu" }, { "category": "Human", "name_of_medicine": "Plegridy", "ema_product_number": "EMEA/H/C/002827", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000286235", "international_non_proprietary_name_common_name": "peginterferon beta-1a", "active_substance": "peginterferon beta-1a", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of relapsing remitting multiple sclerosis in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biogen Netherlands B.V.", "european_commission_decision_date": "11/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/07/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "19/07/2018", "last_updated_date": "17/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/plegridy" }, { "category": "Human", "name_of_medicine": "Pemazyre", "ema_product_number": "EMEA/H/C/005266", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0019", "international_non_proprietary_name_common_name": "pemigatinib", "active_substance": "pemigatinib", "therapeutic_area_mesh": "Cholangiocarcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EN02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Incyte Biosciences Distribution B.V.", "european_commission_decision_date": "02/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "04/05/2021", "last_updated_date": "17/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pemazyre" }, { "category": "Human", "name_of_medicine": "Akeega", "ema_product_number": "EMEA/H/C/005932", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000282377", "international_non_proprietary_name_common_name": "niraparib;abiraterone acetate", "active_substance": "abiraterone acetate;niraparib (tosilate monohydrate)", "therapeutic_area_mesh": "Prostatic Neoplasms, Castration-Resistant", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with prostate cancer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "02/06/2023", "last_updated_date": "17/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/akeega" }, { "category": "Human", "name_of_medicine": "Trydonis", "ema_product_number": "EMEA/H/C/004702", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000294832", "international_non_proprietary_name_common_name": "beclometasone;formoterol;glycopyrronium bromide", "active_substance": "beclometasone dipropionate;formoterol fumarate dihydrate;glycopyrronium", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptoms control and prevention of exacerbations see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A.", "european_commission_decision_date": "16/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/04/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "26/04/2018", "last_updated_date": "17/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trydonis" }, { "category": "Human", "name_of_medicine": "Trimbow", "ema_product_number": "EMEA/H/C/004257", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000294832", "international_non_proprietary_name_common_name": "beclometasone;formoterol;glycopyrronium bromide", "active_substance": "beclometasone dipropionate;formoterol fumarate dihydrate;glycopyrronium bromide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. COPDMaintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1). AsthmaMaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A.", "european_commission_decision_date": "16/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/05/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "17/07/2017", "last_updated_date": "17/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trimbow" }, { "category": "Human", "name_of_medicine": "Pradaxa", "ema_product_number": "EMEA/H/C/000829", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310386", "international_non_proprietary_name_common_name": "dabigatran etexilate", "active_substance": "dabigatran etexilate mesilate", "therapeutic_area_mesh": "Arthroplasty, Replacement;Venous Thromboembolism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AE07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pradaxa 75 mg Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Pradaxa 110 mg Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Pradaxa 150 mg Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "24/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/03/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "46", "first_published_date": "07/06/2018", "last_updated_date": "13/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pradaxa" }, { "category": "Human", "name_of_medicine": "Vazkepa", "ema_product_number": "EMEA/H/C/005398", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000326784", "international_non_proprietary_name_common_name": "icosapent ethyl", "active_substance": "Icosapent ethyl", "therapeutic_area_mesh": "Dyslipidemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated to reduce cardiovascular risk as an adjunct to statin therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Industria Chimica e Farmaceutica S.p.A.", "european_commission_decision_date": "09/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "14/04/2021", "last_updated_date": "13/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vazkepa" }, { "category": "Human", "name_of_medicine": "Arsenic trioxide Accord", "ema_product_number": "EMEA/H/C/005175", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319865", "international_non_proprietary_name_common_name": "arsenic trioxide", "active_substance": "arsenic trioxide", "therapeutic_area_mesh": "Leukemia, Promyelocytic, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 103/?l) in combination with all-trans-retinoic acid (ATRA) Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "13/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "26/11/2019", "last_updated_date": "13/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/arsenic-trioxide-accord" }, { "category": "Human", "name_of_medicine": "Xerava", "ema_product_number": "EMEA/H/C/004237", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000265697", "international_non_proprietary_name_common_name": "eravacycline", "active_substance": "eravacycline", "therapeutic_area_mesh": "Infection;Bacterial Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Tetracyclines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xerava is indicated in adolescents from the age of 12 years weighing at least 50 kg, and in adults, for the treatment of complicated intra-abdominal infections (cIAI). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "PAION Pharma GmbH", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "27/07/2018", "last_updated_date": "13/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xerava" }, { "category": "Human", "name_of_medicine": "Skyclarys", "ema_product_number": "EMEA/H/C/006084", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000328186", "international_non_proprietary_name_common_name": "omaveloxolone", "active_substance": "omaveloxolone", "therapeutic_area_mesh": "Friedreich Ataxia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX25", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "The treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biogen Netherlands B.V.", "european_commission_decision_date": "13/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/02/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "15/12/2023", "last_updated_date": "13/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/skyclarys" }, { "category": "Human", "name_of_medicine": "Vizamyl", "ema_product_number": "EMEA/H/C/002557", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000332942", "international_non_proprietary_name_common_name": "flutemetamol (18F)", "active_substance": "flutemetamol (18F)", "therapeutic_area_mesh": "Radionuclide Imaging;Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Vizamyl is a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of ? amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Vizamyl should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GE Healthcare AS", "european_commission_decision_date": "13/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/06/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "31/07/2017", "last_updated_date": "13/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vizamyl" }, { "category": "Human", "name_of_medicine": "Anktiva", "ema_product_number": "EMEA/H/C/006622", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "nogapendekin alfa inbakicept", "active_substance": "nogapendekin alfa inbakicept", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Anktiva in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Immunitybio Ireland Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/12/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/02/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/12/2025", "last_updated_date": "13/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/anktiva" }, { "category": "Human", "name_of_medicine": "Ebymect", "ema_product_number": "EMEA/H/C/004162", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310736", "international_non_proprietary_name_common_name": "dapagliflozin;metformin", "active_substance": "dapagliflozin propanediol monohydrate;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Type 2 diabetes mellitus For the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. as monotherapy when metformin is considered inappropriate due to intolerance. in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. Type 1 diabetes mellitus Edistride is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ? 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "20/12/2017", "last_updated_date": "13/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ebymect" }, { "category": "Human", "name_of_medicine": "Edistride", "ema_product_number": "EMEA/H/C/004161", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310736", "international_non_proprietary_name_common_name": "dapagliflozin", "active_substance": "dapagliflozin propanediol monohydrate", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2;Heart Failure, Systolic;Heart Failure;Renal Insufficiency, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BK01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Type 2 diabetes mellitus Edistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance. in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Edistride is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Edistride is indicated in adults for the treatment of chronic kidney disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "06/11/2017", "last_updated_date": "13/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/edistride" }, { "category": "Human", "name_of_medicine": "Qtern", "ema_product_number": "EMEA/H/C/004057", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310736", "international_non_proprietary_name_common_name": "saxagliptin;dapagliflozin", "active_substance": "saxagliptin;dapagliflozin propanediol monohydrate", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2;Diabetes Mellitus;Nutritional and Metabolic Diseases;Metabolic Diseases;Glucose Metabolism Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control, when already being treated with the free combination of dapagliflozin and saxagliptin. (See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astra Zeneca AB", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/07/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "20/12/2017", "last_updated_date": "13/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qtern" }, { "category": "Human", "name_of_medicine": "Xigduo", "ema_product_number": "EMEA/H/C/002672", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310736", "international_non_proprietary_name_common_name": "dapagliflozin;metformin", "active_substance": "metformin hydrochloride;dapagliflozin propanediol monohydrate", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Combinations of oral blood glucose lowering drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise: •    in patients insufficiently controlled on their maximally tolerated dose of metformin alone  •    in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products •    in patients already being treated with the combination of dapagliflozin and metformin as separate tablets. For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "20/12/2017", "last_updated_date": "13/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xigduo" }, { "category": "Human", "name_of_medicine": "Elucirem", "ema_product_number": "EMEA/H/C/005626", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249008", "international_non_proprietary_name_common_name": "gadopiclenol", "active_substance": "Gadopiclenol", "therapeutic_area_mesh": "Magnetic Resonance Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V08CA12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Paramagnetic contrast media", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only.Elucirem is indicated in adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:- the brain, spine, and associated tissues of the central nervous system (CNS);- the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.It should be used only when diagnostic information is essential and not available with unenhanced MRI.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Guerbet", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/10/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/12/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "13/10/2023", "last_updated_date": "12/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elucirem" }, { "category": "Human", "name_of_medicine": "Vueway", "ema_product_number": "EMEA/H/C/006172", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249008", "international_non_proprietary_name_common_name": "gadopiclenol", "active_substance": "Gadopiclenol", "therapeutic_area_mesh": "Magnetic Resonance Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V08CA12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Paramagnetic contrast media", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only.Vueway is indicated in adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:- the brain, spine, and associated tissues of the central nervous system (CNS);- the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.It should be used only when diagnostic information is essential and not available with unenhanced MRI.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bracco Imaging S.p.A.", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/10/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/12/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "13/10/2023", "last_updated_date": "12/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vueway" }, { "category": "Human", "name_of_medicine": "Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)", "ema_product_number": "EMEA/H/C/005348", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310403", "international_non_proprietary_name_common_name": "lenalidomide", "active_substance": "lenalidomide hydrochloride monohydrate", "therapeutic_area_mesh": "Multiple Myeloma;Myelodysplastic Syndromes;Lymphoma, Follicular;Lymphoma, Mantle-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1). Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1). Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto ", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "18/02/2021", "last_updated_date": "12/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-krka" }, { "category": "Human", "name_of_medicine": "Quviviq", "ema_product_number": "EMEA/H/C/005634", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000335013", "international_non_proprietary_name_common_name": "daridorexant", "active_substance": "daridorexant hydrochloride", "therapeutic_area_mesh": "Sleep Initiation and Maintenance Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05CJ03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Quviviq is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Idorsia Pharmaceuticals Deutschland GmbH", "european_commission_decision_date": "12/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/04/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "03/05/2022", "last_updated_date": "12/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/quviviq" }, { "category": "Human", "name_of_medicine": "Vitrakvi", "ema_product_number": "EMEA/H/C/004919", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000277850", "international_non_proprietary_name_common_name": "larotrectinib", "active_substance": "larotrectinib sulfate", "therapeutic_area_mesh": "Abdominal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE53", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "09/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "24/10/2019", "last_updated_date": "11/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vitrakvi" }, { "category": "Human", "name_of_medicine": "Vimpat", "ema_product_number": "EMEA/H/C/000863", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000268614", "international_non_proprietary_name_common_name": "lacosamide", "active_substance": "lacosamide", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma SA", "european_commission_decision_date": "08/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/06/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/08/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "57", "first_published_date": "26/07/2018", "last_updated_date": "11/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vimpat" }, { "category": "Human", "name_of_medicine": "Spinraza", "ema_product_number": "EMEA/H/C/004312", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "X/0038", "international_non_proprietary_name_common_name": "nusinersen", "active_substance": "nusinersen sodium", "therapeutic_area_mesh": "Muscular Atrophy, Spinal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biogen Netherlands B.V.", "european_commission_decision_date": "09/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/04/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/05/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "31/08/2018", "last_updated_date": "11/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/spinraza" }, { "category": "Human", "name_of_medicine": "Kirsty (previously Kixelle)", "ema_product_number": "EMEA/H/C/004965", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000335401", "international_non_proprietary_name_common_name": "insulin aspart", "active_substance": "insulin aspart", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "11/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "16/03/2021", "last_updated_date": "11/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kirsty" }, { "category": "Human", "name_of_medicine": "Lysodren", "ema_product_number": "EMEA/H/C/000521", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000322704", "international_non_proprietary_name_common_name": "mitotane", "active_substance": "mitotane", "therapeutic_area_mesh": "Adrenal Cortex Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX23", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Esteve Pharmaceuticals, S.A.", "european_commission_decision_date": "13/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/04/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "25/04/2016", "last_updated_date": "11/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lysodren" }, { "category": "Human", "name_of_medicine": "Ponvory", "ema_product_number": "EMEA/H/C/005163", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000292277", "international_non_proprietary_name_common_name": "ponesimod", "active_substance": "ponesimod", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AE04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoires Juvisé Pharmaceuticals", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/03/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/05/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "24/03/2021", "last_updated_date": "10/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ponvory" }, { "category": "Human", "name_of_medicine": "Kengrexal", "ema_product_number": "EMEA/H/C/003773", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000295860", "international_non_proprietary_name_common_name": "cangrelor", "active_substance": "cangrelor", "therapeutic_area_mesh": "Acute Coronary Syndrome;Vascular Surgical Procedures", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A.", "european_commission_decision_date": "10/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/01/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/03/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "12/04/2018", "last_updated_date": "10/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kengrexal" }, { "category": "Human", "name_of_medicine": "Lydisilka", "ema_product_number": "EMEA/H/C/005382", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000280122", "international_non_proprietary_name_common_name": "estetrol;drospirenone", "active_substance": "estetrol monohydrate;drospirenone", "therapeutic_area_mesh": "Contraceptives, Oral", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Oral contraception. The decision to prescribe Lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lydisilka compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Estetra SPRL", "european_commission_decision_date": "05/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/03/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/05/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "24/03/2021", "last_updated_date": "10/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lydisilka" }, { "category": "Human", "name_of_medicine": "Drovelis", "ema_product_number": "EMEA/H/C/005336", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000280151", "international_non_proprietary_name_common_name": "estetrol;drospirenone", "active_substance": "drospirenone;estetrol monohydrate", "therapeutic_area_mesh": "Contraceptives, Oral", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "oral contraceptive", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "05/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/03/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/05/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "24/03/2021", "last_updated_date": "10/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/drovelis" }, { "category": "Human", "name_of_medicine": "Amversio", "ema_product_number": "EMEA/H/C/005637", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319550", "international_non_proprietary_name_common_name": "betaine anhydrous", "active_substance": "betaine", "therapeutic_area_mesh": "Homocystinuria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in: cystathionine beta-synthase (CBS), 5,10 methylene tetrahydrofolate reductase (MTHFR), cobalamin cofactor metabolism (cbl).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SERB SA", "european_commission_decision_date": "10/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/05/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "21/02/2022", "last_updated_date": "10/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amversio" }, { "category": "Human", "name_of_medicine": "Alkindi", "ema_product_number": "EMEA/H/C/004416", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000334727", "international_non_proprietary_name_common_name": "hydrocortisone", "active_substance": "hydrocortisone", "therapeutic_area_mesh": "Adrenal Insufficiency", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H02AB09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Corticosteroids for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Immedica Netherlands B.V.", "european_commission_decision_date": "10/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/02/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "29/06/2018", "last_updated_date": "10/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alkindi" }, { "category": "Human", "name_of_medicine": "Nucala", "ema_product_number": "EMEA/H/C/003860", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000257645", "international_non_proprietary_name_common_name": "mepolizumab", "active_substance": "Mepolizumab", "therapeutic_area_mesh": "Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03DX09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Severe eosinophilic asthmaNucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older . Chronic rhinosinusitis with nasal polyps (CRSwNP)Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. Eosinophilic granulomatosis with polyangiitis (EGPA)Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA). Hypereosinophilic syndrome (HES)Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "04/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/12/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "01/06/2018", "last_updated_date": "09/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nucala" }, { "category": "Human", "name_of_medicine": "Cayston", "ema_product_number": "EMEA/H/C/000996", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319787", "international_non_proprietary_name_common_name": "aztreonam", "active_substance": "aztreonam lysine", "therapeutic_area_mesh": "Cystic Fibrosis;Respiratory Tract Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01DF01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "09/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "24/05/2018", "last_updated_date": "09/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cayston" }, { "category": "Human", "name_of_medicine": "Sprycel", "ema_product_number": "EMEA/H/C/000709", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320681", "international_non_proprietary_name_common_name": "dasatinib (anhydrous)", "active_substance": "dasatinib", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma;Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML CP) or Ph+ CML CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy. Sprycel is indicated for the treatment of adult patients with: newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase; chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate; Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "24/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/09/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/11/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "47", "first_published_date": "03/08/2018", "last_updated_date": "06/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sprycel" }, { "category": "Human", "name_of_medicine": "Tyruko", "ema_product_number": "EMEA/H/C/005752", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323162", "international_non_proprietary_name_common_name": "natalizumab", "active_substance": "natalizumab", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "02/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/09/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "17/07/2023", "last_updated_date": "06/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tyruko" }, { "category": "Human", "name_of_medicine": "Inhixa", "ema_product_number": "EMEA/H/C/004264", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000332178", "international_non_proprietary_name_common_name": "enoxaparin sodium", "active_substance": "enoxaparin sodium", "therapeutic_area_mesh": "Venous Thromboembolism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Inhixa is indicated for adults for: Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery. Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL). Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism. Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA). Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL). Blood clot prevention in the extracorporeal circulation during haemodialysis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Techdow Pharma Netherlands B.V. ", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "22/06/2018", "last_updated_date": "05/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/inhixa" }, { "category": "Human", "name_of_medicine": "Waskyra", "ema_product_number": "EMEA/H/C/006525", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "etuvetidigene autotemcel", "active_substance": "genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human Wiskott-Aldrich Syndrome (WAS) gene", "therapeutic_area_mesh": "Wiskott-Aldrich Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Waskyra is indicated for the treatment of patients aged 6 months and older with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene for whom haematopoietic stem cell (HSC) transplantation is appropriate and no suitable human leukocyte antigen (HLA)-matched related haematopoietic stem cell donor is available.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fondazione Telethon ETS", "european_commission_decision_date": "09/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/11/2025", "last_updated_date": "05/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/waskyra" }, { "category": "Human", "name_of_medicine": "Toujeo (previously Optisulin)", "ema_product_number": "EMEA/H/C/000309", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310964", "international_non_proprietary_name_common_name": "insulin glargine", "active_substance": "insulin glargine", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi-aventis Deutschland GmbH", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/02/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/06/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "38", "first_published_date": "26/10/2017", "last_updated_date": "05/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/toujeo" }, { "category": "Human", "name_of_medicine": "Apidra", "ema_product_number": "EMEA/H/C/000557", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310964", "international_non_proprietary_name_common_name": "insulin glulisine", "active_substance": "insulin glulisine", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adults, adolescents and children, six years or older with diabetes mellitus, where treatment with insulin is required.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "sanofi-aventis Deutschland GmbH", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "03/06/2004", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/09/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "03/04/2018", "last_updated_date": "05/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/apidra" }, { "category": "Human", "name_of_medicine": "VacPertagen", "ema_product_number": "EMEA/H/C/006304", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000335366", "international_non_proprietary_name_common_name": "pertussis vaccine (recombinant, acellular, component, adsorbed)", "active_substance": "recombinant pertussis toxin;filamentous haemagglutinin", "therapeutic_area_mesh": "Whooping Cough;Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AJ02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "VacPertagen is indicated for: - booster immunisation against pertussis of individuals 12 years of age and older,- passive protection against pertussis in early infancy following maternal immunisation during pregnancy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioNet Europe", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "14/11/2025", "last_updated_date": "05/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vacpertagen" }, { "category": "Human", "name_of_medicine": "Lantus", "ema_product_number": "EMEA/H/C/000284", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310964", "international_non_proprietary_name_common_name": "insulin glargine", "active_substance": "insulin glargine", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus in adults, adolescents and children aged two years and above", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "sanofi-aventis Deutschland GmbH", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/02/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/06/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "43", "first_published_date": "03/04/2018", "last_updated_date": "05/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lantus" }, { "category": "Human", "name_of_medicine": "Insuman", "ema_product_number": "EMEA/H/C/000201", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310964", "international_non_proprietary_name_common_name": "insulin human", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB01;A10AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Diabetes mellitus where treatment with insulin is required. Insuman Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi-aventis Deutschland GmbH", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/10/1996", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/02/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "03/04/2018", "last_updated_date": "05/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/insuman" }, { "category": "Human", "name_of_medicine": "Imatinib Teva", "ema_product_number": "EMEA/H/C/002585", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314304", "international_non_proprietary_name_common_name": "imatinib", "active_substance": "imatinib", "therapeutic_area_mesh": "Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Myelodysplastic-Myeloproliferative Diseases;Hypereosinophilic Syndrome;Dermatofibrosarcoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imatinib Teva is indicated for the treatment of Adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr?abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. Adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon?alpha therapy, or in accelerated phase or blast crisis. Adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. Adult patients with relapsed or refractory Ph+ ALL as monotherapy. Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. Adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR? rearrangement. The effect of imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib Teva is indicated for the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment. The treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "05/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/01/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "25/04/2018", "last_updated_date": "05/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imatinib-teva" }, { "category": "Human", "name_of_medicine": "Simponi", "ema_product_number": "EMEA/H/C/000992", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0121", "international_non_proprietary_name_common_name": "golimumab", "active_substance": "golimumab", "therapeutic_area_mesh": "Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis (RA) Simponi, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function. For information regarding the polyarticular juvenile idiopathic arthritis indication, please see the Simponi 50 mg SmPC. Psoriatic arthritis (PsA) Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Axial spondyloarthritis Ankylosing spondylitis (AS) Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non radiographic axial spondyloarthritis (nr Axial SpA) Simponi is indicated for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Ulcerative colitis (UC) Simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Ulcerative colitisPaediatric ulcerative colitis (pUC)Simponi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body weight of at least 15  kg, who have had an inadequate response to conventional therapy, including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis (pJIA) Simponi in combination with methotrexate (MTX) is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX. Rheumatoid arthritis (RA) Simponi, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis (pJIA) Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX. Psoriatic arthritis (PsA) Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Axial spondyloarthritis Ankylosing spondylitis (AS) Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non radiographic axial spondyloarthritis (nr Axial SpA) Simponi is indicated for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Ulcerative colitis (UC) Simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen Cilag International NV", "european_commission_decision_date": "19/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "54", "first_published_date": "02/07/2018", "last_updated_date": "05/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/simponi" }, { "category": "Human", "name_of_medicine": "Eylea", "ema_product_number": "EMEA/H/C/002392", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000295095", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications;Retinal Vein Occlusion;Choroidal Neovascularization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eylea 114.3 mg/ml solution for injection and Eylea 114.3 mg/ml solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to diabetic macular oedema (DME) visual impairment due to macular oedema secondary to retinal vein occlusion (branch, central and hemiretinal RVO) Eylea 40 mg/mL solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV) Eylea is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease Eylea 40 mg/mL solution for injection in a vial Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/11/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "30/07/2018", "last_updated_date": "04/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eylea" }, { "category": "Human", "name_of_medicine": "mNexspike", "ema_product_number": "EMEA/H/C/006428", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "COVID-19 mRNA vaccine", "active_substance": "single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA template, encoding the N-terminal domain and receptor-binding domain of the viral spike (S) protein of SARS-CoV-2", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BN01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "mNEXSPIKE is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Moderna Biotech Spain, S.L.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/12/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/02/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/12/2025", "last_updated_date": "04/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mnexspike" }, { "category": "Human", "name_of_medicine": "Kefdensis", "ema_product_number": "EMEA/H/C/006490", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000334923", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Kefdensis significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Kefdensis significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stada Arzneimittel AG", "european_commission_decision_date": "04/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "19/09/2025", "last_updated_date": "04/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kefdensis" }, { "category": "Human", "name_of_medicine": "Otezla", "ema_product_number": "EMEA/H/C/003746", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000282235", "international_non_proprietary_name_common_name": "apremilast", "active_substance": "apremilast", "therapeutic_area_mesh": "Arthritis, Psoriatic;Psoriasis;Behcet Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA32", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis (PSOR) in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediatric psoriasisOtezla is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years and weighing at least 20 kg who are candidates for systemic therapy.Behçet’s diseaseOtezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "13/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/01/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "02/08/2018", "last_updated_date": "04/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/otezla" }, { "category": "Human", "name_of_medicine": "Leqvio", "ema_product_number": "EMEA/H/C/005333", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000326844", "international_non_proprietary_name_common_name": "inclisiran", "active_substance": "inclisiran", "therapeutic_area_mesh": "Hypercholesterolemia;Dyslipidemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "04/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/10/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "06/01/2021", "last_updated_date": "04/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/leqvio" }, { "category": "Human", "name_of_medicine": "Hemgenix", "ema_product_number": "EMEA/H/C/004827", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308793", "international_non_proprietary_name_common_name": "etranacogene dezaparvovec", "active_substance": "Etranacogene dezaparvovec", "therapeutic_area_mesh": "Hemophilia B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Blood coagulation factors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "CSL Behring GmbH", "european_commission_decision_date": "29/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/02/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "09/12/2022", "last_updated_date": "04/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hemgenix" }, { "category": "Human", "name_of_medicine": "Xevudy", "ema_product_number": "EMEA/H/C/005676", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000269654", "international_non_proprietary_name_common_name": "sotrovimab", "active_substance": "sotrovimab", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BD05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "16/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/02/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "17/12/2021", "last_updated_date": "04/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xevudy" }, { "category": "Human", "name_of_medicine": "Afqlir", "ema_product_number": "EMEA/H/C/006150", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000324748", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications;Retinal Vein Occlusion", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Afqlir is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (AMD) • visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) • visual impairment due to diabetic macular oedema (DME) • visual impairment due to myopic choroidal neovascularisation (myopic CNV)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "03/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/11/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "20/09/2024", "last_updated_date": "03/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/afqlir" }, { "category": "Human", "name_of_medicine": "Entyvio", "ema_product_number": "EMEA/H/C/002782", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000255408", "international_non_proprietary_name_common_name": "vedolizumab", "active_substance": "vedolizumab", "therapeutic_area_mesh": "Colitis, Ulcerative;Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants;Monoclonal antibodies", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Crohn’s disease Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Pouchitis Entyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/03/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/05/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "23/08/2018", "last_updated_date": "03/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/entyvio" }, { "category": "Human", "name_of_medicine": "Zeposia", "ema_product_number": "EMEA/H/C/004835", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000291324", "international_non_proprietary_name_common_name": "ozanimod", "active_substance": "ozanimod hydrochloride", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting;Colitis, Ulcerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA38", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Multiple sclerosis Zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. Ulcerative colitis Zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/05/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "27/05/2020", "last_updated_date": "03/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zeposia" }, { "category": "Human", "name_of_medicine": "Vyloy", "ema_product_number": "EMEA/H/C/005868", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000293346", "international_non_proprietary_name_common_name": "zolbetuximab", "active_substance": "zolbetuximab", "therapeutic_area_mesh": "Stomach Neoplasms;Esophageal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX31", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first line treatment of adult patients with locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive (see section 4.2).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma Europe B.V.", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "26/07/2024", "last_updated_date": "03/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vyloy" }, { "category": "Human", "name_of_medicine": "Aqneursa", "ema_product_number": "EMEA/H/C/006327", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325234", "international_non_proprietary_name_common_name": "L-acetylleucine", "active_substance": "L-acetylleucine", "therapeutic_area_mesh": "Niemann-Pick Disease, Type C", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aqneursa is indicated for the treatment of neurological manifestations of Niemann-Pick type C (NPC) disease, in combination with miglustat, or as a monotherapy in patients where miglustat is not tolerated, in adults and children aged 6 years and older and weighing at least 20 kg.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intrabio Ireland Limited", "european_commission_decision_date": "11/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/01/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/07/2025", "last_updated_date": "03/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aqneursa" }, { "category": "Veterinary", "name_of_medicine": "Lotilaner / Milbemycin Elanco", "ema_product_number": "EMEA/V/C/006911", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "lotilaner;milbemycin oxime", "active_substance": "lotilaner;milbemycin oxime", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents;Endectocides;Milbemycins;moxidectin, combinations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/01/2026", "last_updated_date": "02/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/lotilaner-milbemycin-elanco" }, { "category": "Human", "name_of_medicine": "Nivestim", "ema_product_number": "EMEA/H/C/001142", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000326464", "international_non_proprietary_name_common_name": "filgrastim", "active_substance": "filgrastim", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ?0.5 x 109/l and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Filgrastim is indicated for the treatment of persistent neutropenia (ANC ?1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/03/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/06/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "23/08/2018", "last_updated_date": "02/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nivestim" }, { "category": "Human", "name_of_medicine": "Retacrit", "ema_product_number": "EMEA/H/C/000872", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000326468", "international_non_proprietary_name_common_name": "epoetin zeta", "active_substance": "epoetin zeta", "therapeutic_area_mesh": "Anemia;Blood Transfusion, Autologous;Kidney Failure, Chronic;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis; treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). Retacrit can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood-saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (four or more units of blood for females or five or more units for males). Retacrit can be used to reduce exposure to allogeneic blood transfusions in adult non-iron-deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1800 ml).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "02/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/12/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "03/08/2018", "last_updated_date": "02/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/retacrit" }, { "category": "Human", "name_of_medicine": "Lamzede", "ema_product_number": "EMEA/H/C/003922", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310242", "international_non_proprietary_name_common_name": "velmanase alfa", "active_substance": "velmanase alfa", "therapeutic_area_mesh": "alpha-Mannosidosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A.", "european_commission_decision_date": "02/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/03/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "23/03/2018", "last_updated_date": "02/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lamzede" }, { "category": "Human", "name_of_medicine": "Fingolimod Accord", "ema_product_number": "EMEA/H/C/005191", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000254070", "international_non_proprietary_name_common_name": "fingolimod", "active_substance": "fingolimod hydrochloride ", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants;Selective immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "05/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/04/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/06/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "03/07/2020", "last_updated_date": "02/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fingolimod-accord" }, { "category": "Human", "name_of_medicine": "Rasilez", "ema_product_number": "EMEA/H/C/000780", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000322560", "international_non_proprietary_name_common_name": "aliskiren", "active_substance": "aliskiren", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09XA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lxo Ireland Designated Activity Company", "european_commission_decision_date": "06/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "04/05/2018", "last_updated_date": "02/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rasilez" }, { "category": "Human", "name_of_medicine": "Pylclari", "ema_product_number": "EMEA/H/C/005520", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000332222", "international_non_proprietary_name_common_name": "piflufolastat (18F)", "active_substance": "Piflufolastat (18F)", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Pylclari is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to initial curative therapy, To localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent. Pylclari is indicated for use with positron emission tomography (PET).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Curium Pet France", "european_commission_decision_date": "02/03/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/05/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/11/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "28/07/2023", "last_updated_date": "02/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pylclari" }, { "category": "Human", "name_of_medicine": "Herceptin", "ema_product_number": "EMEA/H/C/000278", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000313845", "international_non_proprietary_name_common_name": "trastuzumab", "active_substance": "trastuzumab", "therapeutic_area_mesh": "Stomach Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Metastatic breast cancer Herceptin is indicated for the treatment of patients with HER2-positive metastatic breast cancer: as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone-receptor-positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments; in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable; in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease; in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor-positive metastatic breast cancer, not previously treated with trastuzumab. Early breast cancer Herceptin is indicated for the treatment of patients with HER2-positive early breast cancer: following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable); following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel; in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin; in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter. Herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anticancer treatment for their metastatic disease. Herceptin should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC3+ result. Accurate and validated assay methods should be used.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "24/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/08/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "47", "first_published_date": "23/08/2018", "last_updated_date": "02/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin" }, { "category": "Human", "name_of_medicine": "Azomyr", "ema_product_number": "EMEA/H/C/000310", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000312765", "international_non_proprietary_name_common_name": "desloratadine", "active_substance": "desloratadine", "therapeutic_area_mesh": "Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R06AX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihistamines for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Azomyr is indicated for the relief of symptoms associated with: allergic rhinitis (see section 5.1) urticaria (see section 5.1)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "26/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/01/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "55", "first_published_date": "29/06/2018", "last_updated_date": "02/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/azomyr" }, { "category": "Human", "name_of_medicine": "Nexium Control", "ema_product_number": "EMEA/H/C/002618", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000285957", "international_non_proprietary_name_common_name": "esomeprazole", "active_substance": "esomeprazole", "therapeutic_area_mesh": "Gastroesophageal Reflux", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A02BC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Proton pump inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Haleon Ireland Dungarvan Limited", "european_commission_decision_date": "25/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "29/08/2017", "last_updated_date": "02/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nexium-control" }, { "category": "Human", "name_of_medicine": "Ztalmy", "ema_product_number": "EMEA/H/C/005825", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000263646", "international_non_proprietary_name_common_name": "ganaxolone", "active_substance": "ganaxolone", "therapeutic_area_mesh": "Epileptic Syndromes;Spasms, Infantile", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 to 17 years of age. Ztalmy may be continued in patients 18 years of age and older.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Marinus Pharmaceuticals Emerald Limited", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/05/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "24/04/2023", "last_updated_date": "27/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ztalmy" }, { "category": "Human", "name_of_medicine": "Jeraygo", "ema_product_number": "EMEA/H/C/006080", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000297249", "international_non_proprietary_name_common_name": "aprocitentan", "active_substance": "aprocitentan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KN01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of resistant hypertension", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Idorsia Pharmaceuticals Deutschland GmbH", "european_commission_decision_date": "29/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "24/07/2024", "last_updated_date": "27/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jeraygo" }, { "category": "Human", "name_of_medicine": "Zyprexa", "ema_product_number": "EMEA/H/C/000115", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000287642", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Coated tablets Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. Injection Adults Zyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CHEPLAPHARM Registration GmbH", "european_commission_decision_date": "26/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/09/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "47", "first_published_date": "23/02/2017", "last_updated_date": "27/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zyprexa" }, { "category": "Human", "name_of_medicine": "Aumseqa", "ema_product_number": "EMEA/H/C/006069", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Aumolertinib", "active_substance": "Aumolertinib mesilate", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see section 4.2).- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC (forbiomarker-based patient selection, see section 4.2)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SFL Pharmaceuticals Deutschland GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/12/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/02/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/12/2025", "last_updated_date": "27/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aumseqa" }, { "category": "Human", "name_of_medicine": "Nustendi", "ema_product_number": "EMEA/H/C/004959", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000286873", "international_non_proprietary_name_common_name": "bempedoic acid;ezetimibe", "active_substance": "bempedoic acid;ezetimibe", "therapeutic_area_mesh": "Hypercholesterolemia;Dyslipidemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10B", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hypercholesterolaemia and mixed dyslipidaemiaNustendi is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:• in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe • alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statinCardiovascular diseaseNustendi is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:• in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe treatment or,• in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment or, • in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Daiichi Sankyo Europe GmbH", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/03/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "24/04/2020", "last_updated_date": "27/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nustendi" }, { "category": "Human", "name_of_medicine": "Nilemdo", "ema_product_number": "EMEA/H/C/004958", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000286873", "international_non_proprietary_name_common_name": "bempedoic acid", "active_substance": "bempedoic acid", "therapeutic_area_mesh": "Hypercholesterolemia;Dyslipidemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hypercholesterolaemia and mixed dyslipidaemiaNilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL C goals with the maximum tolerated dose of a statin (see sections 4.2, 4.3, and 4.4) or,• alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.Cardiovascular diseaseNilemdo is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:• in patients on a maximum tolerated dose of a statin with or without ezetimibe or,• alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Daiichi Sankyo Europe GmbH", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/04/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "24/04/2020", "last_updated_date": "27/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nilemdo" }, { "category": "Human", "name_of_medicine": "Cometriq", "ema_product_number": "EMEA/H/C/002640", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000271719", "international_non_proprietary_name_common_name": "cabozantinib", "active_substance": "cabozantinib", "therapeutic_area_mesh": "Thyroid Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ipsen Pharma", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/12/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "27/08/2018", "last_updated_date": "27/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cometriq" }, { "category": "Human", "name_of_medicine": "Cabometyx", "ema_product_number": "EMEA/H/C/004163", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000271719", "international_non_proprietary_name_common_name": "cabozantinib", "active_substance": "cabozantinib (s)-malate", "therapeutic_area_mesh": "Carcinoma, Renal Cell;Carcinomas, Hepatocellular", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Renal Cell Carcinoma (RCC) Cabometyx is indicated as monotherapy for advanced renal cell carcinoma as first-line treatment of adult patients with intermediate or poor risk, in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. Hepatocellular carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.Differentiated thyroid carcinoma (DTC)Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.Neuroendocrine Tumours (NET)Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ipsen Pharma", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/09/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "08/05/2018", "last_updated_date": "27/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cabometyx" }, { "category": "Human", "name_of_medicine": "Bysumlog", "ema_product_number": "EMEA/H/C/006158", "medicine_status": "Opinion", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "insulin lispro", "active_substance": "insulin lispro", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gan & Lee Pharmaceuticals Europe GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bysumlog" }, { "category": "Human", "name_of_medicine": "Zumrad", "ema_product_number": "EMEA/H/C/006641", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "sasanlimab", "active_substance": "sasanlimab", "therapeutic_area_mesh": "Urinary Bladder Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FF", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of bladder cancer in adults indicated for the treatment of adult indicated for treatement of bladder cancer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zumrad" }, { "category": "Human", "name_of_medicine": "Flucelvax Tetra", "ema_product_number": "EMEA/H/C/004814", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0047", "international_non_proprietary_name_common_name": "influenza vaccine (surface antigen, inactivated, prepared in cell cultures)", "active_substance": "A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022, CVR-167) A/Massachusetts/18/2022 (H3N2)-like strain (A/Sydney/1304/2022, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type)", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "influenza, inactivated, split virus or surface antigen", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in adults and children from 2 years of age. Flucelvax Tetra should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Seqirus Netherlands B.V.", "european_commission_decision_date": "23/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/12/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "23/02/2026", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "19/10/2018", "last_updated_date": "27/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/flucelvax-tetra" }, { "category": "Human", "name_of_medicine": "Evkeeza", "ema_product_number": "EMEA/H/C/005449", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000293523", "international_non_proprietary_name_common_name": "evinacumab", "active_substance": "Evinacumab", "therapeutic_area_mesh": "Hypercholesterolemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ultragenyx Germany GmbH", "european_commission_decision_date": "23/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/06/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "21/04/2021", "last_updated_date": "26/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evkeeza" }, { "category": "Human", "name_of_medicine": "Mounjaro", "ema_product_number": "EMEA/H/C/005620", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0038", "international_non_proprietary_name_common_name": "tirzepatide", "active_substance": "tirzepatide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2;Obesity;Overweight", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BX16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Type 2 diabetes mellitus Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1. Weight management Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obesity) or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "29/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "18/07/2022", "last_updated_date": "26/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro" }, { "category": "Human", "name_of_medicine": "Adenuric", "ema_product_number": "EMEA/H/C/000777", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0073", "international_non_proprietary_name_common_name": "febuxostat", "active_substance": "febuxostat", "therapeutic_area_mesh": "Gout", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M04AA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antigout preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "80 mg strength: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated in adults. 120 mg strength: Adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Adenuric is indicated in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Menarini International Operations Luxembourg S.A. (MIOL)", "european_commission_decision_date": "12/09/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/04/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "31/05/2018", "last_updated_date": "26/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adenuric" }, { "category": "Human", "name_of_medicine": "Sunlenca", "ema_product_number": "EMEA/H/C/005638", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000313247", "international_non_proprietary_name_common_name": "lenacapavir", "active_substance": "lenacapavir sodium", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4.2 and 5.1). Sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4.2 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland Unlimited Company", "european_commission_decision_date": "19/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/08/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "22/06/2022", "last_updated_date": "26/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sunlenca" }, { "category": "Human", "name_of_medicine": "Fluad Tetra", "ema_product_number": "EMEA/H/C/004993", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0055", "international_non_proprietary_name_common_name": "influenza vaccine (surface antigen, inactivated, adjuvanted)", "active_substance": "A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) / A/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022 IVR-237) / B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) influenza virus", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in adults 50 years of age and older. Fluad Tetra should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Seqirus Netherlands B.V.", "european_commission_decision_date": "19/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/05/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "23/02/2026", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "29/05/2020", "last_updated_date": "26/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fluad-tetra" }, { "category": "Human", "name_of_medicine": "Conexxence", "ema_product_number": "EMEA/H/C/006268", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000332465", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Osteoporosis;Osteoporosis, Postmenopausal;Bone Resorption", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "26/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/07/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "23/05/2025", "last_updated_date": "26/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/conexxence" }, { "category": "Human", "name_of_medicine": "Kisunla", "ema_product_number": "EMEA/H/C/006024", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000327219", "international_non_proprietary_name_common_name": "donanemab", "active_substance": "donanemab", "therapeutic_area_mesh": "Alzheimer Disease;Cognitive Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-dementia drugs;Other anti-dementia drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Donanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early symptomatic Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers with confirmed amyloid pathology (see section 4.4). ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "26/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/09/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "28/03/2025", "last_updated_date": "26/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kisunla" }, { "category": "Human", "name_of_medicine": "Revolade", "ema_product_number": "EMEA/H/C/001110", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000288153", "international_non_proprietary_name_common_name": "eltrombopag", "active_substance": "eltrombopag", "therapeutic_area_mesh": "Purpura, Thrombocytopenic, Idiopathic;Anemia, Aplastic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other systemic hemostatics;Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.4 and 5.1). Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/12/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/03/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "06/07/2018", "last_updated_date": "26/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/revolade" }, { "category": "Human", "name_of_medicine": "Vydura", "ema_product_number": "EMEA/H/C/005725", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308125", "international_non_proprietary_name_common_name": "rimegepant", "active_substance": "rimegepant", "therapeutic_area_mesh": "Migraine Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02CD06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimigraine preparations, calcitonin gene-related peptide (CGRP) antagonists", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vydura is indicated for the Acute treatment of migraine with or without aura in adults; Preventative treatment of episodic migraine in adults who have at least 4 migraine attacks per month.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/04/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "22/02/2022", "last_updated_date": "26/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vydura" }, { "category": "Human", "name_of_medicine": "Yesafili", "ema_product_number": "EMEA/H/C/006022", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000326677", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Macular Edema;Retinal Vein Occlusion;Diabetic Retinopathy;Myopia, Degenerative;Diabetes Complications", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Yesafili is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual impairment due to diabetic macular oedema (DME) (see section 5.1), visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "25/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "17/07/2023", "last_updated_date": "26/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yesafili" }, { "category": "Veterinary", "name_of_medicine": "Orbyk EHD (previously Epizootic haemorrhagic disease vaccine (recombinant protein) Laboratorios Syva S.A.)", "ema_product_number": "EMEA/V/C/006804", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Epizootic haemorrhagic disease vaccine (recombinant protein)", "active_substance": "Epizootic hemorrhagic disease virus, serotype 8, VP2 protein", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "05/12/2025", "last_updated_date": "25/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/Orbyk-EHD" }, { "category": "Human", "name_of_medicine": "Sycrest", "ema_product_number": "EMEA/H/C/001177", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000333312", "international_non_proprietary_name_common_name": "asenapine", "active_substance": "asenapine maleate", "therapeutic_area_mesh": "Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "25/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/06/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/09/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "08/02/2018", "last_updated_date": "25/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sycrest" }, { "category": "Human", "name_of_medicine": "Daxas", "ema_product_number": "EMEA/H/C/001179", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000303126", "international_non_proprietary_name_common_name": "roflumilast", "active_substance": "roflumilast", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03DX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "06/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/07/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "23/04/2018", "last_updated_date": "25/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/daxas" }, { "category": "Human", "name_of_medicine": "DaTSCAN", "ema_product_number": "EMEA/H/C/000266", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310773", "international_non_proprietary_name_common_name": "ioflupane (123l)", "active_substance": "ioflupane (123l)", "therapeutic_area_mesh": "Tomography, Emission-Computed, Single-Photon;Lewy Body Disease;Parkinson Disease;Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09AB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum: In adult patients with clinically uncertain Parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from Parkinsonian syndromes related to idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy. DaTSCAN is unable to discriminate between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy. In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease. DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GE Healthcare B.V.", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/07/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "19/07/2018", "last_updated_date": "25/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/datscan" }, { "category": "Human", "name_of_medicine": "Eltrombopag Accord", "ema_product_number": "EMEA/H/C/006459", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000302834", "international_non_proprietary_name_common_name": "eltrombopag", "active_substance": "eltrombopag olamine", "therapeutic_area_mesh": "Purpura, Thrombocytopenic, Idiopathic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eltrombopag Accord is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Eltrombopag Accord is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Eltrombopag Accord is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "10/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/03/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "31/01/2025", "last_updated_date": "25/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eltrombopag-accord" }, { "category": "Human", "name_of_medicine": "Tadalafil Mylan", "ema_product_number": "EMEA/H/C/003787", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000333449", "international_non_proprietary_name_common_name": "tadalafil", "active_substance": "tadalafil", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Mylan is not indicated for use by women.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "24/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/11/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "03/08/2018", "last_updated_date": "25/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tadalafil-mylan" }, { "category": "Human", "name_of_medicine": "Byooviz", "ema_product_number": "EMEA/H/C/005545", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000324924", "international_non_proprietary_name_common_name": "ranibizumab", "active_substance": "ranibizumab", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetic Retinopathy;Myopia, Degenerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Byooviz is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative diabetic retinopathy (PDR) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) The treatment of visual impairment due to choroidal neovascularisation (CNV)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "24/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/06/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "23/06/2021", "last_updated_date": "25/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/byooviz" }, { "category": "Human", "name_of_medicine": "Tibsovo", "ema_product_number": "EMEA/H/C/005936", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316586", "international_non_proprietary_name_common_name": "ivosidenib", "active_substance": "Ivosidenib", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute;Cholangiocarcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XM02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1). Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "24/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/05/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "12/04/2023", "last_updated_date": "25/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tibsovo" }, { "category": "Human", "name_of_medicine": "Gotenfia", "ema_product_number": "EMEA/H/C/006621", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "golimumab", "active_substance": "golimumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Juvenile;Arthritis, Psoriatic;Axial Spondyloarthritis;Non-Radiographic Axial Spondyloarthritis;Colitis, Ulcerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis (RA)Gotenfia, in combination with methotrexate (MTX), is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.Golimumab, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.Psoriatic arthritis (PsA)Gotenfia, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Golimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Axial spondyloarthritisAnkylosing spondylitis (AS)Gotenfia is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.Non-radiographic axial spondyloarthritis (nr-Axial SpA)Gotenfia is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).Ulcerative colitis (UC)Gotenfia is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritis (pJIA)Gotenfia in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stada Arzneimittel AG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/12/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/02/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/12/2025", "last_updated_date": "25/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gotenfia" }, { "category": "Human", "name_of_medicine": "Vivlipeg", "ema_product_number": "EMEA/H/C/006739", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000326682", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "Neutropenia;Febrile Neutropenia;Chemotherapy-Induced Febrile Neutropenia;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "23/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/06/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "02/10/2025", "last_updated_date": "24/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vivlipeg" }, { "category": "Human", "name_of_medicine": "Enzalutamide Viatris", "ema_product_number": "EMEA/H/C/006299", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000333469", "international_non_proprietary_name_common_name": "enzalutamide", "active_substance": "enzalutamide", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1);• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "23/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "28/06/2024", "last_updated_date": "24/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enzalutamide-viatris" }, { "category": "Human", "name_of_medicine": "Exelon", "ema_product_number": "EMEA/H/C/000169", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000328092", "international_non_proprietary_name_common_name": "rivastigmine", "active_substance": "rivastigmine", "therapeutic_area_mesh": "Dementia;Alzheimer Disease;Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "23/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/05/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "51", "first_published_date": "25/01/2018", "last_updated_date": "24/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exelon" }, { "category": "Human", "name_of_medicine": "Zoledronic Acid Accord", "ema_product_number": "EMEA/H/C/002667", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000333357", "international_non_proprietary_name_common_name": "zoledronic acid", "active_substance": "zoledronic acid monohydrate", "therapeutic_area_mesh": "Hypercalcemia;Fractures, Bone;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bisphosphonates", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "23/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/11/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "04/08/2017", "last_updated_date": "24/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zoledronic-acid-accord" }, { "category": "Human", "name_of_medicine": "Apixaban Accord", "ema_product_number": "EMEA/H/C/005358", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000324419", "international_non_proprietary_name_common_name": "apixaban", "active_substance": "apixaban", "therapeutic_area_mesh": "Venous Thromboembolism;Stroke;Arthroplasty", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AF02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).   Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).   Paediatric population  Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. Adults  Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.   Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).   Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).   Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "24/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/05/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/07/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "06/08/2020", "last_updated_date": "24/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/apixaban-accord" }, { "category": "Human", "name_of_medicine": "Teriflunomide Accord", "ema_product_number": "EMEA/H/C/005960", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000327771", "international_non_proprietary_name_common_name": "teriflunomide", "active_substance": "teriflunomide", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AK02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants;Selective immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Teriflunomide Accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "23/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "14/09/2022", "last_updated_date": "24/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/teriflunomide-accord" }, { "category": "Human", "name_of_medicine": "Eribulin Baxter", "ema_product_number": "EMEA/H/C/006191", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000333602", "international_non_proprietary_name_common_name": "eribulin", "active_substance": "Eribulin mesylate", "therapeutic_area_mesh": "Breast Neoplasms;Liposarcoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX41", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eribulin Baxter is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. Eribulin Baxter is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Baxter Holding B.V.", "european_commission_decision_date": "24/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/06/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "26/04/2024", "last_updated_date": "24/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eribulin-baxter" }, { "category": "Human", "name_of_medicine": "Acvybra", "ema_product_number": "EMEA/H/C/006734", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Acvybra significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Acvybra significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Reddy Holding GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/09/2025", "last_updated_date": "24/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/acvybra" }, { "category": "Human", "name_of_medicine": "Lenalidomide Accord", "ema_product_number": "EMEA/H/C/004857", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000317815", "international_non_proprietary_name_common_name": "lenalidomide", "active_substance": "lenalidomide", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Multiple myelomaLenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphomaLenalidomide Accord in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "24/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "27/07/2018", "last_updated_date": "24/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-accord" }, { "category": "Human", "name_of_medicine": "Fymskina", "ema_product_number": "EMEA/H/C/005805", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000324634", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Crohn Disease;Psoriasis;Arthritis, Psoriatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Plaque psoriasisFymskina is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A).Paediatric plaque psoriasisFymskina is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, and who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA)Fymskina, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Crohn’s DiseaseFymskina is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Formycon AG", "european_commission_decision_date": "23/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "26/07/2024", "last_updated_date": "24/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fymskina" }, { "category": "Human", "name_of_medicine": "Tivdak", "ema_product_number": "EMEA/H/C/005363", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000324286", "international_non_proprietary_name_common_name": "tisotumab vedotin", "active_substance": "tisotumab vedotin", "therapeutic_area_mesh": "Uterine Cervical Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX23", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tivdak as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Genmab A/S", "european_commission_decision_date": "23/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/03/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "31/01/2025", "last_updated_date": "24/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tivdak" }, { "category": "Human", "name_of_medicine": "Tepadina", "ema_product_number": "EMEA/H/C/001046", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316469", "international_non_proprietary_name_common_name": "thiotepa", "active_substance": "thiotepa", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "TEPADINA is indicated, in combination with other chemotherapy medicinal products:- with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;- when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ADIENNE S.r.l. S.U.", "european_commission_decision_date": "23/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/12/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/03/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "29/11/2017", "last_updated_date": "24/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tepadina" }, { "category": "Human", "name_of_medicine": "Inluriyo", "ema_product_number": "EMEA/H/C/006184", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000333242", "international_non_proprietary_name_common_name": "imlunestrant", "active_substance": "imlunestrant tosilate", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen (for biomarker-based patient selection, see section 4.2).In pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "20/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "14/11/2025", "last_updated_date": "23/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/inluriyo" }, { "category": "Human", "name_of_medicine": "Efmody", "ema_product_number": "EMEA/H/C/005105", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000333023", "international_non_proprietary_name_common_name": "hydrocortisone", "active_substance": "hydrocortisone", "therapeutic_area_mesh": "Adrenal Hyperplasia, Congenital", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H02AB09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Corticosteroids for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Immedica Netherlands B.V.", "european_commission_decision_date": "20/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/03/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/05/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "24/03/2021", "last_updated_date": "23/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/efmody" }, { "category": "Human", "name_of_medicine": "Ogivri", "ema_product_number": "EMEA/H/C/004916", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000326197", "international_non_proprietary_name_common_name": "trastuzumab", "active_substance": "trastuzumab", "therapeutic_area_mesh": "Stomach Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Metastatic breast cancer Ogivri is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer                      Ogivri is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC): following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Ogivri therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. Ogivri should only be used in patients with metastatic or EBC whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Ogivri in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Ogivri should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "20/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/12/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "15/09/2017", "last_updated_date": "23/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ogivri" }, { "category": "Human", "name_of_medicine": "Emblaveo", "ema_product_number": "EMEA/H/C/006113", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000326675", "international_non_proprietary_name_common_name": "aztreonam;avibactam", "active_substance": "avibactam;aztreonam", "therapeutic_area_mesh": "Gram-Negative Bacterial Infections;Urinary Tract Infections;Healthcare-Associated Pneumonia;Soft Tissue Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01DF51", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Emblaveo is indicated for the treatment of the following infections in adult patients (see sections 4.4 and 5.1):• Complicated intra-abdominal infection (cIAI)• Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) • Complicated urinary tract infection (cUTI), including pyelonephritisEmblaveo is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options (see sections 4.2, 4.4, and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "20/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "22/03/2024", "last_updated_date": "23/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emblaveo" }, { "category": "Human", "name_of_medicine": "Dawnzera", "ema_product_number": "EMEA/H/C/006554", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "donidalorsen", "active_substance": "donidalorsen", "therapeutic_area_mesh": "Angioedemas, Hereditary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dawnzera is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Otsuka Pharmaceutical Netherlands B.V.", "european_commission_decision_date": "19/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/01/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/11/2025", "last_updated_date": "20/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dawnzera" }, { "category": "Human", "name_of_medicine": "Osqay", "ema_product_number": "EMEA/H/C/006492", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Bone Resorption", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Theramex Ireland Limited", "european_commission_decision_date": "08/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/11/2025", "last_updated_date": "20/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/osqay" }, { "category": "Human", "name_of_medicine": "Semglee", "ema_product_number": "EMEA/H/C/004280", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000326578", "international_non_proprietary_name_common_name": "insulin glargine", "active_substance": "insulin glargine", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "19/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/01/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/03/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "03/04/2018", "last_updated_date": "20/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/semglee" }, { "category": "Human", "name_of_medicine": "Palonosetron Accord", "ema_product_number": "EMEA/H/C/004129", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325357", "international_non_proprietary_name_common_name": "palonosetron", "active_substance": "palonosetron", "therapeutic_area_mesh": "Vomiting;Nausea;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A04AA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiemetics and antinauseants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Palonosetron Accord is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Palonosetron Accord is indicated in paediatric patients 1 month of age and older for: The prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "18/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/03/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "26/05/2016", "last_updated_date": "20/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/palonosetron-accord" }, { "category": "Human", "name_of_medicine": "Lyvdelzi (previously Seladelpar Gilead)", "ema_product_number": "EMEA/H/C/004692", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000290389", "international_non_proprietary_name_common_name": "seladelpar lysine dihydrate", "active_substance": "seladelpar lysine dihydrate", "therapeutic_area_mesh": "Liver Cirrhosis, Biliary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A05AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bile and liver therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lyvdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland Unlimited Company", "european_commission_decision_date": "05/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "13/12/2024", "last_updated_date": "20/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lyvdelzi" }, { "category": "Human", "name_of_medicine": "Kevzara", "ema_product_number": "EMEA/H/C/004254", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323506", "international_non_proprietary_name_common_name": "sarilumab", "active_substance": "sarilumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritisKevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. Polymyalgia rheumaticaKevzara is indicated for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper. Polyarticular juvenile idiopathic arthritis Kevzara is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara may be used as monotherapy or in combination with MTX.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "19/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/04/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/06/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "24/08/2017", "last_updated_date": "20/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kevzara" }, { "category": "Human", "name_of_medicine": "Ameluz", "ema_product_number": "EMEA/H/C/002204", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000332013", "international_non_proprietary_name_common_name": "5-aminolevulinic acid hydrochloride", "active_substance": "5-aminolevulinic acid hydrochloride", "therapeutic_area_mesh": "Keratosis, Actinic;Carcinoma, Basal Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2; see section 5.1) and of field cancerization in adults. Treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biofrontera Bioscience GmbH", "european_commission_decision_date": "18/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/10/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/12/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "24/07/2018", "last_updated_date": "20/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ameluz" }, { "category": "Human", "name_of_medicine": "Casgevy", "ema_product_number": "EMEA/H/C/005763", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000290395", "international_non_proprietary_name_common_name": "exagamglogene autotemcel", "active_substance": "Exagamglogene autotemcel", "therapeutic_area_mesh": "beta-Thalassemia;Anemia, Sickle Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "β thalassemia Casgevy is indicated for the treatment of transfusion dependent β thalassemia (TDT) in patients 12 years of age and older for whom haematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen (HLA) matched related HSC donor is not available. Sickle cell disease Casgevy is indicated for the treatment of severe sickle cell disease (SCD) in patients 12 years of age and older with recurrent vaso occlusive crises (VOCs) for whom haematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen (HLA) matched related HSC donor is not available.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Vertex Pharmaceuticals (Ireland) Limited", "european_commission_decision_date": "10/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/02/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "15/12/2023", "last_updated_date": "19/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/casgevy" }, { "category": "Human", "name_of_medicine": "Klisyri", "ema_product_number": "EMEA/H/C/005183", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000293300", "international_non_proprietary_name_common_name": "tirbanibulin", "active_substance": "tirbanibulin", "therapeutic_area_mesh": "Keratosis, Actinic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D06BX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibiotics and chemotherapeutics for dermatological use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Almirall, S.A.", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/07/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "20/04/2021", "last_updated_date": "19/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/klisyri" }, { "category": "Human", "name_of_medicine": "Nuvaxovid", "ema_product_number": "EMEA/H/C/005808", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000316216", "international_non_proprietary_name_common_name": "COVID-19 Vaccine (recombinant, adjuvanted)", "active_substance": "SARS CoV-2 (Original) recombinant spike protein;SARS-CoV-2 (Omicron XBB.1.5) recombinant spike protein", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BN04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Covid-19 vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nuvaxovid is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. Nuvaxovid XBB.1.5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "21/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/12/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "20/12/2021", "last_updated_date": "19/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nuvaxovid" }, { "category": "Human", "name_of_medicine": "Uptravi", "ema_product_number": "EMEA/H/C/003774", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000324283", "international_non_proprietary_name_common_name": "selexipag", "active_substance": "selexipag", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen Cilag International NV", "european_commission_decision_date": "18/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/05/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "09/04/2018", "last_updated_date": "19/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/uptravi" }, { "category": "Human", "name_of_medicine": "Kigabeq", "ema_product_number": "EMEA/H/C/004534", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000327681", "international_non_proprietary_name_common_name": "vigabatrin", "active_substance": "vigabatrin", "therapeutic_area_mesh": "Spasms, Infantile;Epilepsies, Partial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AG04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for: Treatment in monotherapy of infantile spasms (West's syndrome). Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ORPHELIA Pharma", "european_commission_decision_date": "18/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/06/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "27/07/2018", "last_updated_date": "19/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kigabeq" }, { "category": "Human", "name_of_medicine": "Adzynma", "ema_product_number": "EMEA/H/C/006198", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000255553", "international_non_proprietary_name_common_name": "rADAMTS13", "active_substance": "rADAMTS13", "therapeutic_area_mesh": "Purpura, Thrombotic Thrombocytopenic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AD13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents;Enzymes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of congenital thrombotic thrombocytopenic purpura (cTTP) due to ADAMTS13 deficiency", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Manufacturing Austria AG", "european_commission_decision_date": "09/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "07/08/2024", "last_updated_date": "19/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adzynma" }, { "category": "Human", "name_of_medicine": "Enrylaze", "ema_product_number": "EMEA/H/C/005917", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000326972", "international_non_proprietary_name_common_name": "crisantaspase", "active_substance": "crisantaspase", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Jazz Pharmaceuticals Ireland Limited", "european_commission_decision_date": "16/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "17/07/2023", "last_updated_date": "19/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enrylaze" }, { "category": "Human", "name_of_medicine": "Soliris", "ema_product_number": "EMEA/H/C/000791", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000279366", "international_non_proprietary_name_common_name": "eculizumab", "active_substance": "Eculizumab", "therapeutic_area_mesh": "Hemoglobinuria, Paroxysmal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA25", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Soliris is indicated in adults and children for the treatment of: Paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1).  Atypical haemolytic uremic syndrome (aHUS). Soliris is indicated in adults for the treatment of: Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1). Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Alexion Europe SAS", "european_commission_decision_date": "17/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "41", "first_published_date": "14/12/2017", "last_updated_date": "19/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/soliris" }, { "category": "Human", "name_of_medicine": "Fulphila", "ema_product_number": "EMEA/H/C/004915", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/N/0000326669", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "17/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "21/09/2018", "last_updated_date": "19/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fulphila" }, { "category": "Human", "name_of_medicine": "Hulio", "ema_product_number": "EMEA/H/C/004429", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000326205", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Hidradenitis Suppurativa;Psoriasis;Uveitis;Arthritis, Rheumatoid;Spondylitis, Ankylosing;Crohn Disease;Colitis, Ulcerative;Arthritis, Psoriatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants;Tumor necrosis factor alpha (TNF-α) inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Juvenile idiopathic arthritis  Polyarticular juvenile idiopathic arthritis  Hulio in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Hulio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years.  Enthesitis-related arthritis  Hulio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).  Paediatric plaque psoriasis  Hulio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.  Paediatric Crohn's disease  Hulio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Paediatric Uveitis  Hulio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "17/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "17/09/2018", "last_updated_date": "19/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hulio" }, { "category": "Human", "name_of_medicine": "Orladeyo", "ema_product_number": "EMEA/H/C/005138", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/R/0000282356", "international_non_proprietary_name_common_name": "berotralstat", "active_substance": "berotralstat dihydrochloride", "therapeutic_area_mesh": "Angioedemas, Hereditary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioCryst Ireland Limited", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/02/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/04/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "24/02/2021", "last_updated_date": "18/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orladeyo" }, { "category": "Human", "name_of_medicine": "Zemcelpro", "ema_product_number": "EMEA/H/C/005772", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/N/0000325403", "international_non_proprietary_name_common_name": "allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel", "active_substance": "allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel", "therapeutic_area_mesh": "Hematologic Neoplasms;Hematopoietic Stem Cell Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B05AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other blood products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Cordex Biologics International Limited", "european_commission_decision_date": "17/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/06/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "20/06/2025", "last_updated_date": "18/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zemcelpro" }, { "category": "Human", "name_of_medicine": "Pluvicto", "ema_product_number": "EMEA/H/C/005483", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325276", "international_non_proprietary_name_common_name": "lutetium (177Lu) vipivotide tetraxetan", "active_substance": "lutetium (177Lu) vipivotide tetraxetan", "therapeutic_area_mesh": "Prostatic Neoplasms, Castration-Resistant", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V10XX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Therapeutic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "17/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "21/12/2022", "last_updated_date": "18/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pluvicto" }, { "category": "Human", "name_of_medicine": "Epysqli", "ema_product_number": "EMEA/H/C/006036", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000324351", "international_non_proprietary_name_common_name": "eculizumab", "active_substance": "Eculizumab", "therapeutic_area_mesh": "Hemoglobinuria, Paroxysmal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AJ01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Epysqli is indicated in adults and children for the treatment of:- Paroxysmal nocturnal haemoglobinuria (PNH).Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.- Atypical haemolytic uremic syndrome (aHUS).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "16/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/03/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "27/03/2023", "last_updated_date": "18/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/epysqli" }, { "category": "Human", "name_of_medicine": "Wezenla", "ema_product_number": "EMEA/H/C/006132", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000332249", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Psoriasis;Arthritis, Psoriatic;Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Crohn’s diseaseWezenla is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Pediatric Crohn's diseaseWezenla is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.Plaque psoriasisWezenla is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).Paediatric plaque psoriasisWezenla is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).Psoriatic arthritis (PsA)Wezenla, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Technology (Ireland) UC", "european_commission_decision_date": "13/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "26/04/2024", "last_updated_date": "18/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/wezenla" }, { "category": "Human", "name_of_medicine": "Cejemly", "ema_product_number": "EMEA/H/C/006088", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000332420", "international_non_proprietary_name_common_name": "sugemalimab", "active_substance": "sugemalimab", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FF11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;monoclonal antibodies and antibody drug conjugates;PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cejemly in combination with platinum-based chemotherapy is indicated for the first line treatment of adults with metastatic non small cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations. Cejemly as monotherapy is indicated for the treatment of unresectable stage III NSCLC with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cstone Pharmaceuticals Ireland Limited", "european_commission_decision_date": "16/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/07/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "31/05/2024", "last_updated_date": "18/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cejemly" }, { "category": "Human", "name_of_medicine": "Inflectra", "ema_product_number": "EMEA/H/C/002778", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323223", "international_non_proprietary_name_common_name": "infliximab", "active_substance": "infliximab", "therapeutic_area_mesh": "Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Psoriasis;Crohn Disease;Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease?modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X?ray, has been demonstrated. Adult Crohn’s disease Inflectra is indicated for: treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies; treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric Crohn’s disease Inflectra is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged six to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy. Ulcerative colitis Inflectra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6?mercaptopurine (6?MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents aged six to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6?MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Ankylosing spondylitis Inflectra is indicated for treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Psoriatic arthritis Inflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Inflectra should be administered: in combination with methotrexate; or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X?ray in patients with polyarticular symmetrical subtypes of the disease. Psoriasis Inflectra is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "16/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "30/07/2018", "last_updated_date": "17/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/inflectra" }, { "category": "Human", "name_of_medicine": "Bronchitol", "ema_product_number": "EMEA/H/C/001252", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000288227", "international_non_proprietary_name_common_name": "mannitol", "active_substance": "mannitol", "therapeutic_area_mesh": "Cystic Fibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R05CB16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cough and cold preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharmaxis Europe Limited", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/04/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "08/08/2018", "last_updated_date": "17/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bronchitol" }, { "category": "Human", "name_of_medicine": "Trecondi", "ema_product_number": "EMEA/H/C/004751", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000313406", "international_non_proprietary_name_common_name": "treosulfan", "active_substance": "treosulfan", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "european_commission_decision_date": "13/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "22/07/2019", "last_updated_date": "17/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trecondi" }, { "category": "Human", "name_of_medicine": "Imbruvica", "ema_product_number": "EMEA/H/C/003791", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000327541", "international_non_proprietary_name_common_name": "ibrutinib", "active_substance": "Ibrutinib", "therapeutic_area_mesh": "Lymphoma, Mantle-Cell;Leukemia, Lymphocytic, Chronic, B-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EL01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).Imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory MCL.Imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).Imbruvica as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.Imbruvica as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "13/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/10/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "29/07/2018", "last_updated_date": "17/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imbruvica" }, { "category": "Human", "name_of_medicine": "Lunsumio", "ema_product_number": "EMEA/H/C/005680", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "X/0015", "international_non_proprietary_name_common_name": "mosunetuzumab", "active_substance": "mosunetuzumab", "therapeutic_area_mesh": "Lymphoma, Follicular", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX25", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;monoclonal antibodies and antibody drug conjugates", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/06/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "13/04/2022", "last_updated_date": "16/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lunsumio" }, { "category": "Human", "name_of_medicine": "Pregabalin Zentiva", "ema_product_number": "EMEA/H/C/003900", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "H/C/003900", "international_non_proprietary_name_common_name": "pregabalin", "active_substance": "pregabalin", "therapeutic_area_mesh": "Anxiety Disorders;Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02BF02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Neuropathic pain Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorder Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva, k.s.", "european_commission_decision_date": "13/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/07/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "18/05/2018", "last_updated_date": "16/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pregabalin-zentiva" }, { "category": "Human", "name_of_medicine": "Dovato", "ema_product_number": "EMEA/H/C/004909", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249653", "international_non_proprietary_name_common_name": "dolutegravir;lamivudine", "active_substance": "dolutegravir sodium;lamivudine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dovato is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare B.V.", "european_commission_decision_date": "16/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/07/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "04/09/2019", "last_updated_date": "16/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dovato" }, { "category": "Human", "name_of_medicine": "Luxturna", "ema_product_number": "EMEA/H/C/004451", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000315168", "international_non_proprietary_name_common_name": "voretigene neparvovec", "active_substance": "voretigene neparvovec", "therapeutic_area_mesh": "Leber Congenital Amaurosis;Retinitis Pigmentosa", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "13/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "21/09/2018", "last_updated_date": "16/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/luxturna" }, { "category": "Human", "name_of_medicine": "Hefiya", "ema_product_number": "EMEA/H/C/004865", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308055", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Spondylitis, Ankylosing;Hidradenitis Suppurativa;Psoriasis;Arthritis, Juvenile Rheumatoid;Uveitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Hefiya in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Hefiya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Hefiya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Hefiya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Hefiya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Hefiya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Hefiya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Hefiya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Paediatric plaque psoriasis Hefiya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Hefiya is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Hefiya is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Hefiya is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Paediatric ulcerative colitis Hefiya is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.  Ulcerative colitis  Hefiya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.  Uveitis  Hefiya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.  Paediatric uveitis  Hefiya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "13/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "26/07/2018", "last_updated_date": "16/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hefiya" }, { "category": "Human", "name_of_medicine": "Ibuprofen Gen.Orph", "ema_product_number": "EMEA/H/C/006129", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000325757", "international_non_proprietary_name_common_name": "ibuprofen", "active_substance": "Ibuprofen", "therapeutic_area_mesh": "Ductus Arteriosus, Patent", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01EB16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other cardiac preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gen.Orph", "european_commission_decision_date": "13/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/02/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "15/12/2023", "last_updated_date": "16/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ibuprofen-genorph" }, { "category": "Human", "name_of_medicine": "Enspryng", "ema_product_number": "EMEA/H/C/004788", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/R/0000293585", "international_non_proprietary_name_common_name": "satralizumab", "active_substance": "satralizumab", "therapeutic_area_mesh": "Neuromyelitis Optica", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Satralizumab (Enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "10/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/06/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "20/04/2021", "last_updated_date": "16/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enspryng" }, { "category": "Human", "name_of_medicine": "Vantavo (previously Alendronate sodium and colecalciferol, MSD)", "ema_product_number": "EMEA/H/C/001180", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000326535", "international_non_proprietary_name_common_name": "alendronic acid;colecalciferol", "active_substance": "alendronic acid;colecalciferol", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency. Vantavo reduces the risk of vertebral and hip fractures. Treatment of postmenopausal osteoporosis in patients who are not receiving vitamin-D supplementation and are at risk of vitamin-D insufficiency. Vantavo reduces the risk of vertebral and hip fractures.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "09/07/2018", "last_updated_date": "12/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vantavo" }, { "category": "Human", "name_of_medicine": "Palforzia", "ema_product_number": "EMEA/H/C/004917", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000264359", "international_non_proprietary_name_common_name": "defatted powder of Arachis hypogaea L., semen (peanuts)", "active_substance": "defatted powder of Arachis hypogaea L., semen (peanuts)", "therapeutic_area_mesh": "Peanut Hypersensitivity", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Allergens", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Palforzia is indicated for the treatment of patients aged 1 to 17 years with a confirmed diagnosis of peanut allergy. Palforzia may be continued in patients 18 years of age and older. Palforzia should be used in conjunction with a peanut-avoidant diet.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stallergenes", "european_commission_decision_date": "05/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/10/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/12/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "21/12/2020", "last_updated_date": "12/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/palforzia" }, { "category": "Human", "name_of_medicine": "Infanrix Hexa", "ema_product_number": "EMEA/H/C/000296", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323859", "international_non_proprietary_name_common_name": "diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)", "active_substance": "Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin);hepatitis B surface antigen;poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain));Haemophilus influenzae type b polysaccharide", "therapeutic_area_mesh": "Hepatitis B;Tetanus;Immunization;Meningitis, Haemophilus;Whooping Cough;Poliomyelitis;Diphtheria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07CA09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Infanrix hexa is indicated for primary and booster vaccination of infants from the age of 6 weeks and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b. The use of Infanrix hexa should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/06/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/10/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "49", "first_published_date": "12/04/2018", "last_updated_date": "12/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/infanrix-hexa" }, { "category": "Human", "name_of_medicine": "Retsevmo", "ema_product_number": "EMEA/H/C/005375", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000288253", "international_non_proprietary_name_common_name": "selpercatinib", "active_substance": "selpercatinib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Thyroid Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Retsevmo as monotherapy is indicated for the treatment of adults with:  advanced RET fusion positive non small cell lung cancer (NSCLC) not previously treated with a RET inhibitor advanced RET fusion positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1) Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with: advanced RET fusion positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate) advanced RET mutant medullary thyroid cancer (MTC)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "10/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "23/04/2021", "last_updated_date": "12/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/retsevmo" }, { "category": "Human", "name_of_medicine": "Adrovance", "ema_product_number": "EMEA/H/C/000759", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000326577", "international_non_proprietary_name_common_name": "alendronic acid;colecalciferol", "active_substance": "colecalciferol;alendronic acid (as sodium trihydrate)", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency. Adrovance reduces the risk of vertebral and hip fractures.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "06/07/2018", "last_updated_date": "12/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adrovance" }, { "category": "Human", "name_of_medicine": "Jentadueto", "ema_product_number": "EMEA/H/C/002279", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314303", "international_non_proprietary_name_common_name": "linagliptin;metformin hydrochloride", "active_substance": "linagliptin;metformin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with type-2 diabetes mellitus: Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin. Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "17/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/07/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "20/07/2018", "last_updated_date": "12/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jentadueto" }, { "category": "Human", "name_of_medicine": "Trajenta", "ema_product_number": "EMEA/H/C/002110", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0058", "international_non_proprietary_name_common_name": "linagliptin", "active_substance": "linagliptin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BH05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults: as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. as combination therapy in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "24/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "26/06/2018", "last_updated_date": "12/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trajenta" }, { "category": "Human", "name_of_medicine": "Foscan", "ema_product_number": "EMEA/H/C/000318", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0041/G", "international_non_proprietary_name_common_name": "temoporfin", "active_substance": "temoporfin", "therapeutic_area_mesh": "Head and Neck Neoplasms;Carcinoma, Squamous Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XD05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biolitec Pharma Ltd", "european_commission_decision_date": "29/03/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/10/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "29/03/2016", "last_updated_date": "12/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/foscan" }, { "category": "Human", "name_of_medicine": "Fosavance", "ema_product_number": "EMEA/H/C/000619", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000326529", "international_non_proprietary_name_common_name": "alendronic acid;colecalciferol", "active_substance": "alendronic acid;colecalciferol", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency. Fosavance reduces the risk of vertebral and hip fractures.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "12/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/05/2005", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/08/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "09/07/2018", "last_updated_date": "12/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fosavance" }, { "category": "Human", "name_of_medicine": "Kyinsu", "ema_product_number": "EMEA/H/C/006279", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "insulin icodec;semaglutide", "active_substance": "insulin icodec;semaglutide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE57", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Insulins and analogues for injection, long-acting", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kyinsu is indicated for the treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists as an adjunct to diet and exercise in addition to oral antidiabetic medicinal products. For study results with respect to combinations, effects on glycaemic control, and the populations studied, see sections 4.4, 4.5 and 5.1.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/09/2025", "last_updated_date": "12/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kyinsu" }, { "category": "Human", "name_of_medicine": "Imjudo", "ema_product_number": "EMEA/H/C/006016", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00011038/202410", "international_non_proprietary_name_common_name": "tremelimumab", "active_substance": "tremelimumab", "therapeutic_area_mesh": "Carcinoma, Hepatocellular;Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX20", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "04/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/02/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "09/12/2022", "last_updated_date": "11/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imjudo" }, { "category": "Human", "name_of_medicine": "Steglatro", "ema_product_number": "EMEA/H/C/004315", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000313037", "international_non_proprietary_name_common_name": "ertugliflozin", "active_substance": "ertugliflozin l-pyroglutamic acid", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BK04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Sodium-glucose co-transporter 2 (SGLT2) inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. in addition to other medicinal products for the treatment of diabetes.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "21/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/01/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "26/04/2018", "last_updated_date": "11/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/steglatro" }, { "category": "Human", "name_of_medicine": "Romvimza", "ema_product_number": "EMEA/H/C/006363", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000326525", "international_non_proprietary_name_common_name": "vimseltinib", "active_substance": "vimseltinib dihydrate", "therapeutic_area_mesh": "Giant Cell Tumor of Tendon Sheath", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Romvimza is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Deciphera Pharmaceuticals (Netherlands) B.V.", "european_commission_decision_date": "11/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/07/2025", "last_updated_date": "11/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/romvimza" }, { "category": "Human", "name_of_medicine": "Qinlock", "ema_product_number": "EMEA/H/C/005614", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000326560", "international_non_proprietary_name_common_name": "ripretinib", "active_substance": "ripretinib", "therapeutic_area_mesh": "Gastrointestinal Stromal Tumors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Deciphera Pharmaceuticals (Netherlands) B.V.", "european_commission_decision_date": "11/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/11/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "23/11/2021", "last_updated_date": "11/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qinlock" }, { "category": "Human", "name_of_medicine": "Lumark", "ema_product_number": "EMEA/H/C/002749", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010391/201912", "international_non_proprietary_name_common_name": "lutetium (177Lu) chloride", "active_substance": "lutetium (177Lu) chloride", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Therapeutic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lumark is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "I.D.B. Radiopharmacy B.V.", "european_commission_decision_date": "17/09/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/06/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "16/01/2026", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "04/04/2018", "last_updated_date": "11/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lumark" }, { "category": "Human", "name_of_medicine": "HyQvia", "ema_product_number": "EMEA/H/C/002491", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0101", "international_non_proprietary_name_common_name": "human normal immunoglobulin", "active_substance": "human normal immunoglobulin", "therapeutic_area_mesh": "Immunologic Deficiency Syndromes;Polyradiculoneuropathy;Polyradiculoneuropathy, Chronic Inflammatory Demyelinating", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Replacement therapy in adults, children and adolescents (0-18 years) in: Primary immunodeficiency syndromes with impaired antibody production. Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of < 4 g/L. *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. Immunomodulatory therapy in adults, children and adolescents (0 to 18 years) in: Chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Baxalta Innovations GmbH", "european_commission_decision_date": "03/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/05/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "26/07/2018", "last_updated_date": "11/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hyqvia" }, { "category": "Human", "name_of_medicine": "Winlevi", "ema_product_number": "EMEA/H/C/006138", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "clascoterone", "active_substance": "clascoterone", "therapeutic_area_mesh": "Acne Vulgaris", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D10AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other anti-acne preparations for topical use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Winlevi is indicated for the treatment of acne vulgaris. Adolescents (from 12 to < 18 years of age) Winlevi is indicated for the treatment of facial acne vulgaris.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cassiopea S.p.A.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/08/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/10/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/04/2025", "last_updated_date": "10/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/winlevi" }, { "category": "Human", "name_of_medicine": "Datroway", "ema_product_number": "EMEA/H/C/006547", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325249", "international_non_proprietary_name_common_name": "datopotamab deruxtecan", "active_substance": "datopotamab deruxtecan", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX35", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancerDatroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Daiichi Sankyo Europe GmbH", "european_commission_decision_date": "09/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/04/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "31/01/2025", "last_updated_date": "09/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/datroway" }, { "category": "Human", "name_of_medicine": "Lytenava", "ema_product_number": "EMEA/H/C/005723", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000320474", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Wet Macular Degeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lytenava is indicated in adults for treatment of neovascular (wet) age-related macular degeneration (nAMD).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Outlook Therapeutics NL B. V.", "european_commission_decision_date": "04/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/05/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "22/03/2024", "last_updated_date": "09/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lytenava" }, { "category": "Human", "name_of_medicine": "Zypadhera", "ema_product_number": "EMEA/H/C/000890", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000312459", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine pamoate", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CHEPLAPHARM Registration GmbH", "european_commission_decision_date": "13/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/09/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "23/02/2017", "last_updated_date": "09/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zypadhera" }, { "category": "Human", "name_of_medicine": "Azopt", "ema_product_number": "EMEA/H/C/000267", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323373", "international_non_proprietary_name_common_name": "brinzolamide", "active_substance": "brinzolamide", "therapeutic_area_mesh": "Glaucoma, Open-Angle;Ocular Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01EC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Azopt is indicated to decrease elevated intraocular pressure in: ocular hypertension; open-angle glaucomaas monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "09/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/03/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "22/06/2018", "last_updated_date": "09/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/azopt" }, { "category": "Human", "name_of_medicine": "Xadago", "ema_product_number": "EMEA/H/C/002396", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000327326", "international_non_proprietary_name_common_name": "safinamide", "active_substance": "safinamide methanesulfonate", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04B", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xadago is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zambon SpA", "european_commission_decision_date": "09/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/02/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "20/12/2017", "last_updated_date": "09/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xadago" }, { "category": "Human", "name_of_medicine": "Tepkinly", "ema_product_number": "EMEA/H/C/005985", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325305", "international_non_proprietary_name_common_name": "epcoritamab", "active_substance": "epcoritamab", "therapeutic_area_mesh": "Lymphoma, Large B-Cell, Diffuse", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "06/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/09/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "17/07/2023", "last_updated_date": "06/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tepkinly" }, { "category": "Human", "name_of_medicine": "Bildyos", "ema_product_number": "EMEA/H/C/006434", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316652", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Bone Resorption;Osteoporosis, Postmenopausal;Osteoporosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. Inpostmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hipfractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased riskof fractures. In men with prostate cancer receiving hormone ablation, denosumabsignificantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients atincreased risk of fracture.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sciencepharma Sp. z o.o", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "25/07/2025", "last_updated_date": "06/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bildyos" }, { "category": "Human", "name_of_medicine": "Helicobacter Test INFAI", "ema_product_number": "EMEA/H/C/000140", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000325105", "international_non_proprietary_name_common_name": "13C-urea", "active_substance": "urea (13C)", "therapeutic_area_mesh": "Breath Tests;Helicobacter Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V04CX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in: adults; adolescents, who are likely to have peptic ulcer disease. Helicobacter Test INFAI for children aged three to 11 years may be used for in vivo diagnosis of gastrduodenal Helicobacter pylori infection: for the evaluation of the success of eradication treatment, or; when invasive tests cannot be performed, or; when there are discordant results arising from invasive tests. This medicinal product is for diagnostic use only.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "INFAI, Institut für biomedizinische Analytik NMR-Imaging GmbH", "european_commission_decision_date": "06/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/04/1997", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/08/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "07/03/2018", "last_updated_date": "06/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/helicobacter-test-infai" }, { "category": "Human", "name_of_medicine": "Tuznue", "ema_product_number": "EMEA/H/C/006252", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000301399", "international_non_proprietary_name_common_name": "trastuzumab", "active_substance": "trastuzumab", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Metastatic breast cancer (MBC) For the treatment of adult patients with HER2-positive MBC: as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy unless patients are unsuitable for these treatments. in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab  Early breast cancer (EBC) For the treatment of adult patients with HER2-positive EBC: following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant HD201 therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter.  HD201 should only be used in patients with MBC or EBC whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer (MGC) In combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of adult patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. HD201 should only be used in patients with MGC whose tumours have HER2 overexpression as defined by Immunohistochemistry (IHC) 2+ and a confirmatory silver-enhanced in situ hybridisation (SISH) or fluorescence in situ hybridisation (FISH) result, or by an IHC 3+ result. Accurate and validated assay methods should be used.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Prestige Biopharma Belgium", "european_commission_decision_date": "23/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "26/07/2024", "last_updated_date": "06/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tuznue" }, { "category": "Human", "name_of_medicine": "Cibinqo", "ema_product_number": "EMEA/H/C/005452", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010976/202409", "international_non_proprietary_name_common_name": "abrocitinib", "active_substance": "abrocitinib", "therapeutic_area_mesh": "Dermatitis, Atopic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D11AH08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other dermatological preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "23/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/10/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "17/12/2021", "last_updated_date": "06/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cibinqo" }, { "category": "Human", "name_of_medicine": "Exforge HCT", "ema_product_number": "EMEA/H/C/001068", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000321249", "international_non_proprietary_name_common_name": "amlodipine besilate;valsartan;hydrochlorothiazide", "active_substance": "valsartan;hydrochlorothiazide;amlodipine besilate", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "05/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "07/06/2018", "last_updated_date": "06/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exforge-hct" }, { "category": "Human", "name_of_medicine": "Alymsys", "ema_product_number": "EMEA/H/C/005286", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/N/0000326153", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Colorectal Neoplasms;Breast Neoplasms;Ovarian Neoplasms;Peritoneal Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Uterine Cervical Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. Alymsys in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Alymsys in combination with capecitabine. Alymsys, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. Alymsys, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Alymsys, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Alymsys, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Alymsys, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Alymsys, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mabxience Research SL", "european_commission_decision_date": "06/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "26/04/2021", "last_updated_date": "06/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alymsys" }, { "category": "Human", "name_of_medicine": "Dafiro HCT", "ema_product_number": "EMEA/H/C/001160", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000321249", "international_non_proprietary_name_common_name": "amlodipine besilate;valsartan;hydrochlorothiazide", "active_substance": "valsartan;hydrochlorothiazide;amlodipine besilate", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "05/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/11/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "25/06/2018", "last_updated_date": "06/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dafiro-hct" }, { "category": "Human", "name_of_medicine": "Copalia HCT", "ema_product_number": "EMEA/H/C/001159", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000321249", "international_non_proprietary_name_common_name": "amlodipine;valsartan;hydrochlorothiazide", "active_substance": "amlodipine;valsartan;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system;Angiotensin II antagonists and calcium channel blockers;Angiotensin II antagonists, combinations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "05/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/11/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "17/04/2018", "last_updated_date": "06/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/copalia-hct" }, { "category": "Human", "name_of_medicine": "Rayvow", "ema_product_number": "EMEA/H/C/005332", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315499", "international_non_proprietary_name_common_name": "lasmiditan", "active_substance": "lasmiditan succinate", "therapeutic_area_mesh": "Migraine Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02CC08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "RAYVOW is indicated for the acute treatment of the headache phase of migraine attacks, with or without aura in adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "05/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/08/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "14/09/2021", "last_updated_date": "06/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rayvow" }, { "category": "Human", "name_of_medicine": "Insulin aspart Sanofi", "ema_product_number": "EMEA/H/C/005033", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000325334", "international_non_proprietary_name_common_name": "insulin aspart", "active_substance": "insulin aspart", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Insulin aspart Sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "05/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/04/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/06/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "07/07/2020", "last_updated_date": "06/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-aspart-sanofi" }, { "category": "Human", "name_of_medicine": "Azarga", "ema_product_number": "EMEA/H/C/000960", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323366", "international_non_proprietary_name_common_name": "brinzolamide;timolol", "active_substance": "brinzolamide;timolol maleate", "therapeutic_area_mesh": "Glaucoma, Open-Angle;Ocular Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01ED51", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Decrease of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "04/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/11/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "22/06/2018", "last_updated_date": "06/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/azarga" }, { "category": "Human", "name_of_medicine": "Dasatinib Accord Healthcare", "ema_product_number": "EMEA/H/C/006251", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000324500", "international_non_proprietary_name_common_name": "dasatinib", "active_substance": "Dasatinib monohydrate", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma;Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dasatinib Accord Healthcare is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.  Dasatinib Accord Healthcare is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ ALL in combination with chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "04/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "31/05/2024", "last_updated_date": "05/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dasatinib-accord-healthcare" }, { "category": "Human", "name_of_medicine": "Kesimpta", "ema_product_number": "EMEA/H/C/005410", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000276182", "international_non_proprietary_name_common_name": "ofatumumab", "active_substance": "ofatumumab", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressant", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "09/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "16/04/2021", "last_updated_date": "05/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kesimpta" }, { "category": "Human", "name_of_medicine": "Clopidogrel Zentiva (previously Clopidogrel Winthrop)", "ema_product_number": "EMEA/H/C/000975", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0091", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel", "therapeutic_area_mesh": "Stroke;Peripheral Vascular Diseases;Myocardial Infarction;Acute Coronary Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Secondary prevention of atherothrombotic events Clopidogrel is indicated in: adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease; adult patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva k.s.", "european_commission_decision_date": "06/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/04/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/07/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "30/04/2018", "last_updated_date": "05/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-zentiva" }, { "category": "Human", "name_of_medicine": "Vanflyta", "ema_product_number": "EMEA/H/C/005910", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000325243", "international_non_proprietary_name_common_name": "quizartinib", "active_substance": "quizartinib dihydrochloride", "therapeutic_area_mesh": "Leukemia, Myeloid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by Vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Daiichi Sankyo Europe GmbH", "european_commission_decision_date": "03/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/11/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "15/09/2023", "last_updated_date": "05/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vanflyta" }, { "category": "Human", "name_of_medicine": "Lyxumia", "ema_product_number": "EMEA/H/C/002445", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000223999", "international_non_proprietary_name_common_name": "lixisenatide", "active_substance": "lixisenatide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Glucagon-like peptide-1 (GLP-1) analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "27/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/11/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/01/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/12/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "18/09/2017", "last_updated_date": "05/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lyxumia" }, { "category": "Human", "name_of_medicine": "Yuflyma", "ema_product_number": "EMEA/H/C/005188", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000295845", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing;Uveitis;Hidradenitis Suppurativa;Colitis, Ulcerative;Crohn Disease;Arthritis, Juvenile Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Yuflyma in combination with methotrexate, is indicated for: - the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Yuflyma in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Yuflyma is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Yuflyma is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Yuflyma is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Yuflyma is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Yuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Yuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Yuflyma is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Yuflyma is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Yuflyma is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Yuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Yuflyma is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Yuflyma is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "30/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "26/02/2021", "last_updated_date": "05/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yuflyma" }, { "category": "Human", "name_of_medicine": "DuoTrav", "ema_product_number": "EMEA/H/C/000665", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323360", "international_non_proprietary_name_common_name": "travoprost;timolol", "active_substance": "travoprost;timolol", "therapeutic_area_mesh": "Glaucoma, Open-Angle;Ocular Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01ED51", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "03/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "15/02/2018", "last_updated_date": "05/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duotrav" }, { "category": "Human", "name_of_medicine": "Avzivi", "ema_product_number": "EMEA/H/C/005574", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000322269", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Colorectal Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Ovarian Neoplasms;Fallopian Tube Neoplasms;Peritoneal Neoplasms;Uterine Cervical Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer and recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer first-line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer. first line treatment of patients with advanced and/or metastatic renal cell cancer.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "FGK Representative Service GmbH", "european_commission_decision_date": "27/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "08/08/2024", "last_updated_date": "05/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/avzivi" }, { "category": "Human", "name_of_medicine": "Tocilizumab STADA (previously Tofidence)", "ema_product_number": "EMEA/H/C/005984", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320498", "international_non_proprietary_name_common_name": "tocilizumab", "active_substance": "tocilizumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;COVID-19 virus infection;Arthritis, Juvenile Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis (RA): - the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with methotrexate (MTX) (monotherapy or in combination with MTX). - the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumor necrosis factor (TNF) antagonists (monotherapy or in combination with MTX). Coronavirus disease 2019 (COVID-19): the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Polyarticular juvenile idiopathic arthritis (pJIA): the treatment of juvenile idiopathic polyarthritis (PJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX (monotherapy or in combination with MTX). Systemic juvenile idiopathic arthritis (sJIA): the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (monotherapy or in combination with MTX).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "STADA Arzneimittel AG", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "10/07/2024", "last_updated_date": "05/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tocilizumab-stada" }, { "category": "Human", "name_of_medicine": "Prevenar 13", "ema_product_number": "EMEA/H/C/001104", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000309455", "international_non_proprietary_name_common_name": "pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)", "active_substance": "Pneumococcal polysaccharide serotype 1;Pneumococcal polysaccharide serotype 3;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 5;Pneumococcal polysaccharide serotype 6A;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 7F;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19A;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 23F", "therapeutic_area_mesh": "Pneumococcal Infections;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AL02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age. Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults ?18 years of age and the elderly. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "50", "first_published_date": "19/03/2018", "last_updated_date": "05/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prevenar-13" }, { "category": "Human", "name_of_medicine": "Sugammadex Amomed", "ema_product_number": "EMEA/H/C/005935", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323967", "international_non_proprietary_name_common_name": "sugammadex", "active_substance": "sugammadex sodium", "therapeutic_area_mesh": "Neuromuscular Blockade", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AB35", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reversal of neuromuscular blockade induced by rocuronium or vecuronium. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in paediatric patients from birth to 17 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AOP Orphan Pharmaceuticals GmbH", "european_commission_decision_date": "02/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/01/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "04/11/2022", "last_updated_date": "04/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sugammadex-amomed" }, { "category": "Human", "name_of_medicine": "Imraldi", "ema_product_number": "EMEA/H/C/004279", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282472", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Spondylitis, Ankylosing;Arthritis, Rheumatoid;Uveitis;Colitis, Ulcerative;Psoriasis;Arthritis, Psoriatic;Crohn Disease;Hidradenitis Suppurativa;Arthritis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Imraldi in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Imraldi in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Imraldi is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Imraldi is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Imraldi is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Imraldi is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function. Psoriasis Imraldi is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Imraldi is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Imraldi is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Imraldi is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Imraldi is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have Ulcerative colitis Imraldi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Imraldi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Imraldi is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whomcorticosteroid treatment is inappropriate. Paediatric Uveitis Imraldi is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/06/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/08/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "12/07/2018", "last_updated_date": "04/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imraldi" }, { "category": "Human", "name_of_medicine": "Gilenya", "ema_product_number": "EMEA/H/C/002202", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323955", "international_non_proprietary_name_common_name": "fingolimod", "active_substance": "fingolimod hydrochloride ", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1). or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "02/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/01/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/03/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "41", "first_published_date": "02/07/2018", "last_updated_date": "03/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gilenya" }, { "category": "Human", "name_of_medicine": "Trazimera", "ema_product_number": "EMEA/H/C/004463", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/N/0000326120", "international_non_proprietary_name_common_name": "trastuzumab", "active_substance": "trastuzumab", "therapeutic_area_mesh": "Stomach Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Metastatic breast cancer Trazimera is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer: (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Trazimera is indicated for the treatment of adult patients with HER2 positive early breast cancer. (EBC). following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Trazimera therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. Trazimera should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Trazimera in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Trazimera should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "02/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/05/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "14/09/2018", "last_updated_date": "03/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trazimera" }, { "category": "Human", "name_of_medicine": "GalliaPharm", "ema_product_number": "EMEA/H/C/006053", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323795", "international_non_proprietary_name_common_name": "gallium (68Ga) chloride;germanium (68Ge) chloride", "active_substance": "gallium (68Ga) chloride;germanium (68Ge) chloride", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This radionuclide generator is not intended for direct use in patients. The sterile eluate (gallium (68Ga) chloride solution) from the radionuclide generator GalliaPharm is indicated for in vitro radiolabelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling with such eluate, to be used for positron emission tomography (PET) imaging.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eckert & Ziegler Radiopharma GmbH", "european_commission_decision_date": "02/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "31/05/2024", "last_updated_date": "03/02/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/galliapharm" }, { "category": "Human", "name_of_medicine": "Trisenox", "ema_product_number": "EMEA/H/C/000388", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000281747", "international_non_proprietary_name_common_name": "arsenic trioxide", "active_substance": "arsenic trioxide", "therapeutic_area_mesh": "Leukemia, Promyelocytic, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trisenox is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 103/µl) in combination with all?trans?retinoic acid (ATRA) Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/03/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "07/12/2017", "last_updated_date": "30/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trisenox" }, { "category": "Human", "name_of_medicine": "Pemetrexed Accord", "ema_product_number": "EMEA/H/C/004072", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000244639", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed disodium hemipentahydrate", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Mesothelioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Malignant pleural mesothelioma Pemetrexed Accord in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Accord in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Accord is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Accord is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "10/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/01/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "20/04/2018", "last_updated_date": "30/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-accord" }, { "category": "Human", "name_of_medicine": "Kineret", "ema_product_number": "EMEA/H/C/000363", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249038", "international_non_proprietary_name_common_name": "anakinra", "active_substance": "anakinra", "therapeutic_area_mesh": "Arthritis, Rheumatoid;COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid Arthritis (RA) Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone. COVID-19 Kineret is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) ? 6 ng/ml. Periodic fever syndromes Kineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above: Cryopyrin-Associated Periodic Syndromes (CAPS) Kineret is indicated for the treatment of CAPS, including: Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) Muckle-Wells Syndrome (MWS) Familial Cold Autoinflammatory Syndrome (FCAS) Familial Mediterranean Fever (FMF) Kineret is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate. Still’s Disease Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Swedish Orphan Biovitrum AB (publ)", "european_commission_decision_date": "04/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/03/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "38", "first_published_date": "06/04/2018", "last_updated_date": "30/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kineret" }, { "category": "Human", "name_of_medicine": "Scenesse", "ema_product_number": "EMEA/H/C/002548", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0052", "international_non_proprietary_name_common_name": "afamelanotide", "active_substance": "afamelanotide", "therapeutic_area_mesh": "Protoporphyria, Erythropoietic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D02BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Emollients and protectives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Clinuvel Europe Limited", "european_commission_decision_date": "18/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/10/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/12/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "01/12/2015", "last_updated_date": "30/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/scenesse" }, { "category": "Human", "name_of_medicine": "Trulicity", "ema_product_number": "EMEA/H/C/002825", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000321382", "international_non_proprietary_name_common_name": "dulaglutide", "active_substance": "dulaglutide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Blood glucose lowering drugs, excl. insulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "30/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/09/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/11/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "02/07/2018", "last_updated_date": "30/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trulicity" }, { "category": "Human", "name_of_medicine": "Zubsolv", "ema_product_number": "EMEA/H/C/004407", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000313397", "international_non_proprietary_name_common_name": "buprenorphine;naloxone", "active_substance": "buprenorphine hydrochloride;naloxone hydrochloride dihydrate", "therapeutic_area_mesh": "Opioid-Related Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07BC51", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "08/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "02/02/2018", "last_updated_date": "29/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zubsolv" }, { "category": "Human", "name_of_medicine": "INOmax", "ema_product_number": "EMEA/H/C/000337", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000269511", "international_non_proprietary_name_common_name": "nitric oxide", "active_substance": "nitric oxide", "therapeutic_area_mesh": "Hypertension, Pulmonary;Respiratory Insufficiency", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R07AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other respiratory system products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated: for the treatment of newborn infants ?34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation; as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Linde Healthcare AB", "european_commission_decision_date": "15/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/08/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "22/03/2018", "last_updated_date": "29/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/inomax" }, { "category": "Human", "name_of_medicine": "Insulin lispro Sanofi", "ema_product_number": "EMEA/H/C/004303", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000324558", "international_non_proprietary_name_common_name": "insulin lispro", "active_substance": "insulin lispro", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "28/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/05/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "03/04/2018", "last_updated_date": "29/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-lispro-sanofi" }, { "category": "Human", "name_of_medicine": "Zykadia", "ema_product_number": "EMEA/H/C/003819", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323613", "international_non_proprietary_name_common_name": "ceritinib", "active_substance": "ceritinib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with crizotinib.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "28/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/05/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "06/07/2018", "last_updated_date": "29/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zykadia" }, { "category": "Veterinary", "name_of_medicine": "Varenzin", "ema_product_number": "EMEA/V/C/006513", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "molidustat", "active_substance": "molidustat sodium", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "ANTIANEMIC PREPARATIONS", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "05/12/2025", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/varenzin" }, { "category": "Human", "name_of_medicine": "Heplisav B", "ema_product_number": "EMEA/H/C/005063", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000271891", "international_non_proprietary_name_common_name": "hepatitis B surface antigen", "active_substance": "hepatitis B surface antigen", "therapeutic_area_mesh": "Hepatitis B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Heplisav B is indicated for the active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The use of Heplisav B should be in accordance with official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with Heplisav B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dynavax GmbH", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "01/03/2021", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/heplisav-b" }, { "category": "Human", "name_of_medicine": "Biktarvy", "ema_product_number": "EMEA/H/C/004449", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000274445", "international_non_proprietary_name_common_name": "bictegravir;emtricitabine;tenofovir alafenamide", "active_substance": "bictegravir;emtricitabine;tenofovir alafenamide;fumarate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR20", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Biktarvy is indicated for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg i without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.(see section 5.1)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "12/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/06/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "21/06/2018", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/biktarvy" }, { "category": "Human", "name_of_medicine": "Erbitux", "ema_product_number": "EMEA/H/C/000558", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323569", "international_non_proprietary_name_common_name": "cetuximab", "active_substance": "cetuximab", "therapeutic_area_mesh": "Head and Neck Neoplasms;Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer: in combination with irinotecan-based chemotherapy; in first-line in combination with FOLFOX; as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. For details, see section 5.1. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck: in combination with radiation therapy for locally advanced disease; in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Europe B.V. ", "european_commission_decision_date": "28/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/06/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "02/06/2017", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/erbitux" }, { "category": "Human", "name_of_medicine": "Leflunomide Zentiva (previously Leflunomide Winthrop)", "ema_product_number": "EMEA/H/C/001129", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319733", "international_non_proprietary_name_common_name": "leflunomide", "active_substance": "leflunomide", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Psoriatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AK01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva k.s.", "european_commission_decision_date": "28/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "09/04/2018", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/leflunomide-zentiva" }, { "category": "Human", "name_of_medicine": "Saphnelo", "ema_product_number": "EMEA/H/C/004975", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316675", "international_non_proprietary_name_common_name": "anifrolumab", "active_substance": "anifrolumab", "therapeutic_area_mesh": "Lupus Erythematosus, Systemic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AG11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Monoclonal antibodies", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "28/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "16/12/2021", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/saphnelo" }, { "category": "Human", "name_of_medicine": "Hukyndra", "ema_product_number": "EMEA/H/C/005548", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320439", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Arthritis, Psoriatic;Arthritis, Juvenile Rheumatoid;Arthritis, Rheumatoid;Colitis, Ulcerative;Crohn Disease;Hidradenitis Suppurativa;Psoriasis;Spondylitis, Ankylosing;Uveitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis \t\t\tHukyndra in combination with methotrexate, is indicated for: \t\t\t- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate. \t\t\t- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis \t\t\tPolyarticular juvenile idiopathic arthritis \t\t\tHukyndra in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more DMARD. Hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis \t\t\tHukyndra is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis \t\t\tAnkylosing spondylitis (AS) \t\t\tHukyndra is indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS \t\t\tHukyndra is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis \t\t\tHukyndra is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis \t\t\tHukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis \t\t\tHukyndra is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) \t\t\tHukyndra is indicated for the treatment of active moderate to severe HS (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease \t\t\tHukyndra is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease \t\t\tHukyndra is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis \t\t\tHukyndra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis \t\t\tHukyndra is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis \t\t\tHukyndra is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis \t\t\tHukyndra is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stada Arzneimittel AG", "european_commission_decision_date": "28/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "14/09/2021", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hukyndra" }, { "category": "Human", "name_of_medicine": "Koselugo", "ema_product_number": "EMEA/H/C/005244", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "X/0018/G", "international_non_proprietary_name_common_name": "selumetinib", "active_substance": "selumetinib sulfate", "therapeutic_area_mesh": "Neurofibromatosis 1", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EE04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult and paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and older. Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1) aged 1 year to less than 7 years and for older patients with swallowing difficulties.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "09/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/06/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "13/10/2021", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/koselugo" }, { "category": "Human", "name_of_medicine": "Abevmy", "ema_product_number": "EMEA/H/C/005327", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000326198", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Colorectal Neoplasms;Breast Neoplasms;Ovarian Neoplasms;Fallopian Tube Neoplasms;Peritoneal Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Uterine Cervical Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Abevmy in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). Abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics [FIGO] stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). Abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5.1). Abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "16/02/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/02/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/04/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "24/02/2021", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abevmy" }, { "category": "Human", "name_of_medicine": "Vegzelma", "ema_product_number": "EMEA/H/C/005534", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000274402", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Colorectal Neoplasms;Breast Neoplasms;Ovarian Neoplasms;Fallopian Tube Neoplasms;Peritoneal Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Uterine Cervical Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "VEGZELMA in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. VEGZELMA in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. VEGZELMA in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with VEGZELMA in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. VEGZELMA, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (NSCLC) other than predominantly squamous cell histology. VEGZELMA, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). VEGZELMA, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. VEGZELMA, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). VEGZELMA, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor–targeted agents. VEGZELMA in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5.1). VEGZELMA, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/08/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "20/06/2022", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vegzelma" }, { "category": "Human", "name_of_medicine": "Oyavas", "ema_product_number": "EMEA/H/C/005556", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000278081", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Colorectal Neoplasms;Breast Neoplasms;Ovarian Neoplasms;Fallopian Tube Neoplasms;Peritoneal Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Uterine Cervical Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Oyavas in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Oyavas in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Oyavas in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Oyavas, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. Oyavas, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). Oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Oyavas, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). Oyavas, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Oyavas, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents (see Section 5.1). Oyavas, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "STADA Arzneimittel AG", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "15/04/2021", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/oyavas" }, { "category": "Human", "name_of_medicine": "Aybintio", "ema_product_number": "EMEA/H/C/005106", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000274402", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Colorectal Neoplasms;Breast Neoplasms;Ovarian Neoplasms;Fallopian Tube Neoplasms;Peritoneal Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Uterine Cervical Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1 of the SmPC. Aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Aybintio in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1 of the SmPC. Aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1 of the SmPC). Aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1 of the SmPC). Aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents (see section 5.1 of the SmPC). Aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1 of the SmPC).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/08/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "02/09/2020", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aybintio" }, { "category": "Human", "name_of_medicine": "Zavesca", "ema_product_number": "EMEA/H/C/000435", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0077", "international_non_proprietary_name_common_name": "miglustat", "active_substance": "miglustat", "therapeutic_area_mesh": "Gaucher Disease;Niemann-Pick Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zavesca is indicated for the oral treatment of adult patients with mild to moderate type-1 Gaucher disease. Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type-C disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen Cilag International NV", "european_commission_decision_date": "25/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/11/2002", "refusal_of_marketing_authorisation_date": "16/06/2009", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "03/05/2018", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zavesca" }, { "category": "Human", "name_of_medicine": "Herzuma", "ema_product_number": "EMEA/H/C/002575", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000324305", "international_non_proprietary_name_common_name": "trastuzumab", "active_substance": "trastuzumab", "therapeutic_area_mesh": "Stomach Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Metastatic breast cancer Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Herzuma is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC): following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Herzuma therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. Herzuma should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Herzuma in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Herzuma should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "26/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/02/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "23/08/2018", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/herzuma" }, { "category": "Human", "name_of_medicine": "Dexdor", "ema_product_number": "EMEA/H/C/002268", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000320486", "international_non_proprietary_name_common_name": "dexmedetomidine", "active_substance": "Dexmedetomidine hydrochloride", "therapeutic_area_mesh": "Conscious Sedation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05CM18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For sedation of adult intensive care unit patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Orion Corporation", "european_commission_decision_date": "26/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "08/12/2017", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dexdor" }, { "category": "Human", "name_of_medicine": "Vpriv", "ema_product_number": "EMEA/H/C/001249", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0063", "international_non_proprietary_name_common_name": "velaglucerase alfa", "active_substance": "velaglucerase alfa", "therapeutic_area_mesh": "Gaucher Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vpriv is indicated for long-term enzyme-replacement therapy (ERT) in patients with type-1 Gaucher disease.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland Branch", "european_commission_decision_date": "15/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "04/06/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "16/04/2018", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vpriv" }, { "category": "Human", "name_of_medicine": "Jaypirca", "ema_product_number": "EMEA/H/C/005863", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315519", "international_non_proprietary_name_common_name": "pirtobrutinib", "active_substance": "pirtobrutinib", "therapeutic_area_mesh": "Lymphoma, Mantle-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) who have been previously treated with a BTK inhibitor.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "27/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/10/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "20/11/2023", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jaypirca" }, { "category": "Human", "name_of_medicine": "Tadalafil Lilly", "ema_product_number": "EMEA/H/C/004666", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315293", "international_non_proprietary_name_common_name": "tadalafil", "active_substance": "tadalafil", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Lilly is not indicated for use by women. Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "27/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/01/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/03/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "12/06/2017", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tadalafil-lilly" }, { "category": "Human", "name_of_medicine": "Cialis", "ema_product_number": "EMEA/H/C/000436", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315293", "international_non_proprietary_name_common_name": "tadalafil", "active_substance": "tadalafil", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of erectile dysfunction. In order for tadalafil to be effective, sexual stimulation is required. Cialis is not indicated for use by women.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "27/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2002", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/11/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "23/03/2017", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cialis" }, { "category": "Human", "name_of_medicine": "Omvoh", "ema_product_number": "EMEA/H/C/005122", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315519", "international_non_proprietary_name_common_name": "mirikizumab", "active_substance": "mirikizumab", "therapeutic_area_mesh": "Colitis, Ulcerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "27/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/03/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "27/03/2023", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/omvoh" }, { "category": "Human", "name_of_medicine": "Forsteo", "ema_product_number": "EMEA/H/C/000425", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315293", "international_non_proprietary_name_common_name": "teriparatide", "active_substance": "teriparatide", "therapeutic_area_mesh": "Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "27/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/03/2003", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/06/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "26/06/2018", "last_updated_date": "28/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/forsteo" }, { "category": "Human", "name_of_medicine": "Emgality", "ema_product_number": "EMEA/H/C/004648", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315519", "international_non_proprietary_name_common_name": "galcanezumab", "active_substance": "Galcanezumab", "therapeutic_area_mesh": "Migraine Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics;galcanezumab", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "27/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "14/02/2018", "last_updated_date": "27/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emgality" }, { "category": "Human", "name_of_medicine": "Optruma", "ema_product_number": "EMEA/H/C/000185", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315293", "international_non_proprietary_name_common_name": "raloxifene", "active_substance": "raloxifene hydrochloride", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03XC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Optruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "27/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/08/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "03/08/2017", "last_updated_date": "27/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/optruma" }, { "category": "Human", "name_of_medicine": "Adcirca (previously Tadalafil Lilly)", "ema_product_number": "EMEA/H/C/001021", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315293", "international_non_proprietary_name_common_name": "tadalafil", "active_substance": "tadalafil", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "AdultsTreatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease. Paediatric populationTreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "27/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/10/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "23/03/2017", "last_updated_date": "27/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adcirca" }, { "category": "Human", "name_of_medicine": "Minjuvi", "ema_product_number": "EMEA/H/C/005436", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000255975", "international_non_proprietary_name_common_name": "tafasitamab", "active_substance": "tafasitamab", "therapeutic_area_mesh": "Lymphoma, Large B-Cell, Diffuse", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Minjuvi is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Incyte Biosciences Distribution B.V.", "european_commission_decision_date": "15/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/06/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "23/06/2021", "last_updated_date": "27/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/minjuvi" }, { "category": "Human", "name_of_medicine": "Cetrotide", "ema_product_number": "EMEA/H/C/000233", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000322807", "international_non_proprietary_name_common_name": "cetrorelix", "active_substance": "cetrorelix (as acetate)", "therapeutic_area_mesh": "Ovulation;Ovulation Induction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01CC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques. In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Europe B.V.", "european_commission_decision_date": "27/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/04/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "23/07/2018", "last_updated_date": "27/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cetrotide" }, { "category": "Human", "name_of_medicine": "Constella", "ema_product_number": "EMEA/H/C/002490", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323621", "international_non_proprietary_name_common_name": "linaclotide", "active_substance": "linaclotide", "therapeutic_area_mesh": "Irritable Bowel Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A06AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for constipation", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "27/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/11/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "17/04/2018", "last_updated_date": "27/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/constella" }, { "category": "Human", "name_of_medicine": "Avastin", "ema_product_number": "EMEA/H/C/000582", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316070", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Breast Neoplasms;Ovarian Neoplasms;Colorectal Neoplasms;Carcinoma, Renal Cell;Fallopian Tube Neoplasms;Peritoneal Neoplasms;Uterine Cervical Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information as to HER2 status. Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.Bevacizumab, in combination with carboplatin and gemcitabine, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "12/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/01/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "68", "first_published_date": "09/08/2018", "last_updated_date": "27/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/avastin" }, { "category": "Human", "name_of_medicine": "Mvasi", "ema_product_number": "EMEA/H/C/004728", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000274402", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Carcinoma, Renal Cell;Peritoneal Neoplasms;Ovarian Neoplasms;Breast Neoplasms;Carcinoma, Non-Small-Cell Lung;Fallopian Tube Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mvasi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Mvasi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Mvasi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. Mvasi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Mvasi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Mvasi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Technology (Ireland) UC", "european_commission_decision_date": "19/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "08/11/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/01/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "12/02/2018", "last_updated_date": "27/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mvasi" }, { "category": "Human", "name_of_medicine": "Briviact (in Italy: Nubriveo)", "ema_product_number": "EMEA/H/C/003898", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000266248", "international_non_proprietary_name_common_name": "brivaracetam", "active_substance": "Brivaracetam", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX23", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Briviact is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma SA", "european_commission_decision_date": "19/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/01/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "11/07/2018", "last_updated_date": "27/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/briviact-italy-nubriveo" }, { "category": "Human", "name_of_medicine": "Wainzua", "ema_product_number": "EMEA/H/C/006295", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314198", "international_non_proprietary_name_common_name": "eplontersen", "active_substance": "eplontersen sodium", "therapeutic_area_mesh": "Amyloid Neuropathies, Familial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB ", "european_commission_decision_date": "26/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/03/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "18/10/2024", "last_updated_date": "27/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/wainzua" }, { "category": "Human", "name_of_medicine": "Levetiracetam Actavis", "ema_product_number": "EMEA/H/C/002355", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308189", "international_non_proprietary_name_common_name": "levetiracetam", "active_substance": "levetiracetam", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Levetiracetam Actavis is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Actavis is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/10/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "21/03/2018", "last_updated_date": "26/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-actavis" }, { "category": "Human", "name_of_medicine": "Levetiracetam Teva", "ema_product_number": "EMEA/H/C/002316", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308189", "international_non_proprietary_name_common_name": "levetiracetam", "active_substance": "levetiracetam", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Nervous system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Levetiracetam Teva is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam Teva is indicated as adjunctive therapy: in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/08/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "30/06/2025", "last_updated_date": "26/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-teva" }, { "category": "Human", "name_of_medicine": "Levetiracetam Actavis Group", "ema_product_number": "EMEA/H/C/002305", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308189", "international_non_proprietary_name_common_name": "levetiracetam", "active_substance": "levetiracetam", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Levetiracetam Actavis Group is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Actavis Group is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/12/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "20/03/2018", "last_updated_date": "26/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-actavis-group" }, { "category": "Human", "name_of_medicine": "Levetiracetam ratiopharm", "ema_product_number": "EMEA/H/C/002244", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308189", "international_non_proprietary_name_common_name": "levetiracetam", "active_substance": "levetiracetam", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Levetiracetam ratiopharm is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam ratiopharm is indicated as adjunctive therapy: in the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ratiopharm GmbH", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "10/08/2017", "last_updated_date": "26/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-ratiopharm" }, { "category": "Human", "name_of_medicine": "Recarbrio", "ema_product_number": "EMEA/H/C/004808", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000265089", "international_non_proprietary_name_common_name": "imipenem;cilastatin;relebactam", "active_substance": "imipenem monohydrate;cilastatin sodium;relebactam monohydrate", "therapeutic_area_mesh": "Gram-Negative Bacterial Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01DH56", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use;Carbapenems", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Recarbrio is indicated for:- Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults (see sections 4.4 and 5.1).- Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults.- Treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4, and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "19/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/02/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "26/02/2020", "last_updated_date": "26/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/recarbrio" }, { "category": "Human", "name_of_medicine": "Avtozma", "ema_product_number": "EMEA/H/C/006196", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000280589", "international_non_proprietary_name_common_name": "tocilizumab", "active_substance": "tocilizumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Cytokine Release Syndrome;COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Avtozma, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Avtozma is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Avtozma can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Avtozma in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older. Avtozma, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Avtozma can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Avtozma in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients. Avtozma, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 12 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (see Section 4.2). Avtozma can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Avtozma in combination with methotrexate (MTX) is indicated for thetreatment of juvenile idiopathic polyarthritis (pJIA; rheumatoidfactor positive or negative and extended oligoarthritis) in patients 12 years of age and older, who have responded inadequately to previous therapy with MTX (see Section4.2). Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "11/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "13/12/2024", "last_updated_date": "26/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/avtozma" }, { "category": "Human", "name_of_medicine": "Enurev Breezhaler", "ema_product_number": "EMEA/H/C/002691", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320523", "international_non_proprietary_name_common_name": "glycopyrronium bromide", "active_substance": "glycopyrronium bromide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03BB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd", "european_commission_decision_date": "23/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/09/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "13/07/2017", "last_updated_date": "26/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enurev-breezhaler" }, { "category": "Human", "name_of_medicine": "Tovanor Breezhaler", "ema_product_number": "EMEA/H/C/002690", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320523", "international_non_proprietary_name_common_name": "glycopyrronium bromide", "active_substance": "glycopyrronium bromide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03BB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "23/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/09/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "09/07/2018", "last_updated_date": "26/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tovanor-breezhaler" }, { "category": "Human", "name_of_medicine": "Seebri Breezhaler", "ema_product_number": "EMEA/H/C/002430", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320523", "international_non_proprietary_name_common_name": "glycopyrronium bromide", "active_substance": "glycopyrronium bromide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03BB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Seebri Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "23/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/09/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "09/07/2018", "last_updated_date": "26/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/seebri-breezhaler" }, { "category": "Human", "name_of_medicine": "Triumeq", "ema_product_number": "EMEA/H/C/002754", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000316075", "international_non_proprietary_name_common_name": "abacavir;dolutegravir;lamivudine", "active_substance": "dolutegravir sodium;lamivudine;abacavir (as sulfate)", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Triumeq is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infected children of at least 3 months of age weighing at least 6 kg to less than 25 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele. Triumeq is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infected adults, adolescents and children weighing at least 25 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare B.V.", "european_commission_decision_date": "23/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/06/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/08/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "12/07/2018", "last_updated_date": "26/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/triumeq" }, { "category": "Human", "name_of_medicine": "Zegalogue", "ema_product_number": "EMEA/H/C/006214", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000316252", "international_non_proprietary_name_common_name": "dasiglucagon", "active_substance": "dasiglucagon hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H04AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pancreatic hormones", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zegalogue is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zealand Pharma A/S", "european_commission_decision_date": "19/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/07/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "31/05/2024", "last_updated_date": "26/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zegalogue" }, { "category": "Human", "name_of_medicine": "Ronapreve", "ema_product_number": "EMEA/H/C/005814", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000254621", "international_non_proprietary_name_common_name": "casirivimab;imdevimab", "active_substance": "casirivimab;imdevimab", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ronapreve is indicated for:- Treatment of COVID-19 in adults, adolescents and children aged 2 years and older weighing at least 10 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.- Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result. - Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg.Ronapreve should be used in accordance with official recommendations where available and based on information on the activity of casirivimab and imdevimab against presently circulating viral variants.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH ", "european_commission_decision_date": "03/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/11/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/11/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "05/12/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "12/11/2021", "last_updated_date": "23/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ronapreve" }, { "category": "Human", "name_of_medicine": "Austedo", "ema_product_number": "EMEA/H/C/006371", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "deutetrabenazine", "active_substance": "deutetrabenazine", "therapeutic_area_mesh": "Tardive Dyskinesia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of moderate to severe tardive dyskinesia in adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "05/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/06/2025", "last_updated_date": "23/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/austedo" }, { "category": "Human", "name_of_medicine": "Nexviadyme", "ema_product_number": "EMEA/H/C/005501", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0018", "international_non_proprietary_name_common_name": "avalglucosidase alfa", "active_substance": "avalglucosidase alfa", "therapeutic_area_mesh": "Glycogen Storage Disease Type II", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid ?-glucosidase deficiency).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi B.V.", "european_commission_decision_date": "06/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/11/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/06/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "20/07/2021", "last_updated_date": "23/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nexviadyme" }, { "category": "Human", "name_of_medicine": "Travatan", "ema_product_number": "EMEA/H/C/000390", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323305", "international_non_proprietary_name_common_name": "travoprost", "active_substance": "travoprost", "therapeutic_area_mesh": "Glaucoma, Open-Angle;Ocular Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01EE04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1). Decrease of elevated intraocular pressure in paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/11/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "03/08/2018", "last_updated_date": "23/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/travatan" }, { "category": "Human", "name_of_medicine": "Simbrinza", "ema_product_number": "EMEA/H/C/003698", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323316", "international_non_proprietary_name_common_name": "brinzolamide;brimonidine tartrate", "active_substance": "brinzolamide;brimonidine tartrate", "therapeutic_area_mesh": "Ocular Hypertension;Glaucoma, Open-Angle", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01EC54", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/07/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "23/08/2018", "last_updated_date": "23/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/simbrinza" }, { "category": "Human", "name_of_medicine": "Nevanac", "ema_product_number": "EMEA/H/C/000818", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323425", "international_non_proprietary_name_common_name": "nepafenac", "active_substance": "nepafenac", "therapeutic_area_mesh": "Pain, Postoperative;Ophthalmologic Surgical Procedures", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01BC10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nevanac is indicated for: prevention and treatment of postoperative pain and inflammation associated with cataract surgery; reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "21/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/12/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "23/08/2018", "last_updated_date": "23/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nevanac" }, { "category": "Human", "name_of_medicine": "Elahere", "ema_product_number": "EMEA/H/C/005036", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323227", "international_non_proprietary_name_common_name": "mirvetuximab soravtansine", "active_substance": "mirvetuximab soravtansine", "therapeutic_area_mesh": "Ovarian Neoplasms;Fallopian Tube Neoplasms;Peritoneal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX26", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Elahere as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "20/09/2024", "last_updated_date": "23/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elahere" }, { "category": "Human", "name_of_medicine": "Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)", "ema_product_number": "EMEA/H/C/003803", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000321295", "international_non_proprietary_name_common_name": "aripiprazole", "active_substance": "aripiprazole", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/06/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "02/02/2018", "last_updated_date": "23/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aripiprazole-mylan-pharma" }, { "category": "Human", "name_of_medicine": "Vyvgart", "ema_product_number": "EMEA/H/C/005849", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000291882", "international_non_proprietary_name_common_name": "efgartigimod alfa", "active_substance": "efgartigimod alfa", "therapeutic_area_mesh": "Myasthenia Gravis;Polyradiculoneuropathy, Chronic Inflammatory Demyelinating", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA58", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vyvgart is indicated as- an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are antiacetylcholine receptor (AChR) antibody positive.- monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Argenx", "european_commission_decision_date": "11/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/08/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "20/06/2022", "last_updated_date": "23/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vyvgart" }, { "category": "Human", "name_of_medicine": "Ontruzant", "ema_product_number": "EMEA/H/C/004323", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320521", "international_non_proprietary_name_common_name": "trastuzumab", "active_substance": "trastuzumab", "therapeutic_area_mesh": "Stomach Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Metastatic breast cancer Ontruzant is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Ontruzant is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Ontruzant therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter. Ontruzant should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Ontruzant in combination with capecitabine or 5?fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Ontruzant should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "22/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "13/08/2018", "last_updated_date": "23/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ontruzant" }, { "category": "Human", "name_of_medicine": "Opatanol", "ema_product_number": "EMEA/H/C/000407", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323571", "international_non_proprietary_name_common_name": "olopatadine", "active_substance": "olopatadine hydrochloride", "therapeutic_area_mesh": "Conjunctivitis, Allergic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01GX09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "21/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/05/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "19/04/2018", "last_updated_date": "22/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opatanol" }, { "category": "Human", "name_of_medicine": "Erivedge", "ema_product_number": "EMEA/H/C/002602", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000304963", "international_non_proprietary_name_common_name": "vismodegib", "active_substance": "vismodegib", "therapeutic_area_mesh": "Carcinoma, Basal Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX43", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "04/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/07/2013", "refusal_of_marketing_authorisation_date": "26/04/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "15/03/2018", "last_updated_date": "22/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/erivedge" }, { "category": "Human", "name_of_medicine": "Lacosamide Adroiq", "ema_product_number": "EMEA/H/C/006047", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000322698", "international_non_proprietary_name_common_name": "lacosamide", "active_substance": "lacosamide", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Lacosamide Adroiq is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Extrovis EU Ltd", "european_commission_decision_date": "21/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/03/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/05/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "27/03/2023", "last_updated_date": "21/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lacosamide-adroiq" }, { "category": "Human", "name_of_medicine": "Lyumjev (previously Liumjev)", "ema_product_number": "EMEA/H/C/005037", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315488", "international_non_proprietary_name_common_name": "insulin lispro", "active_substance": "insulin lispro", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. Treatment of diabetes mellitus in adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "21/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/03/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "16/04/2020", "last_updated_date": "21/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lyumjev" }, { "category": "Human", "name_of_medicine": "Liprolog", "ema_product_number": "EMEA/H/C/000393", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315488", "international_non_proprietary_name_common_name": "insulin lispro", "active_substance": "insulin lispro", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB04;A10AD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilisation of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "21/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2001", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/08/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "23/10/2017", "last_updated_date": "21/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/liprolog" }, { "category": "Human", "name_of_medicine": "Humalog", "ema_product_number": "EMEA/H/C/000088", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315488", "international_non_proprietary_name_common_name": "insulin lispro", "active_substance": "insulin lispro", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB04;A10AD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "21/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/04/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "01/02/2018", "last_updated_date": "21/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/humalog" }, { "category": "Human", "name_of_medicine": "Abasaglar (previously Abasria)", "ema_product_number": "EMEA/H/C/002835", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315488", "international_non_proprietary_name_common_name": "insulin glargine", "active_substance": "insulin glargine", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "21/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/06/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/09/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "27/02/2018", "last_updated_date": "21/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abasaglar" }, { "category": "Human", "name_of_medicine": "Abraxane", "ema_product_number": "EMEA/H/C/000778", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000311114", "international_non_proprietary_name_common_name": "paclitaxel", "active_substance": "paclitaxel", "therapeutic_area_mesh": "Breast Neoplasms;Pancreatic Neoplasms;Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "20/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "30/07/2018", "last_updated_date": "21/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abraxane" }, { "category": "Human", "name_of_medicine": "Ponlimsi", "ema_product_number": "EMEA/H/C/006238", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000320143", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Ponlimsi significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Ponlimsi significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva GmbH", "european_commission_decision_date": "19/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "19/09/2025", "last_updated_date": "20/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ponlimsi" }, { "category": "Human", "name_of_medicine": "Veyvondi", "ema_product_number": "EMEA/H/C/004454", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000264863", "international_non_proprietary_name_common_name": "vonicog alfa", "active_substance": "vonicog alfa", "therapeutic_area_mesh": "von Willebrand Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention and treatment of haemorrhage or surgical bleeding in adults (age 18 years and older) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. Veyvondi should not be used in the treatment of Haemophilia A.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Baxalta Innovations GmbH", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/05/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/08/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "31/08/2018", "last_updated_date": "20/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/veyvondi" }, { "category": "Human", "name_of_medicine": "Nyvepria", "ema_product_number": "EMEA/H/C/005085", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000321402", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "20/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/09/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/11/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "23/11/2020", "last_updated_date": "20/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nyvepria" }, { "category": "Human", "name_of_medicine": "Libtayo", "ema_product_number": "EMEA/H/C/004844", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000264999", "international_non_proprietary_name_common_name": "cemiplimab", "active_substance": "cemiplimab", "therapeutic_area_mesh": "Carcinoma, Squamous Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC33", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cutaneous Squamous Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation. Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation (see section 5.1 for selection criteria).  Basal Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). Non-Small Cell Lung Cancer Libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ? 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Libtayo in combination with platinum?based chemotherapy is indicated for the first?line treatment of adult patients with NSCLC expressing PD-L1 (in ? 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Cervical Cancer Libtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Regeneron Ireland Designated Activity Company (DAC)", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/06/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "05/07/2019", "last_updated_date": "20/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/libtayo" }, { "category": "Human", "name_of_medicine": "Imnovid (previously Pomalidomide Celgene)", "ema_product_number": "EMEA/H/C/002682", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PASS/0000262876", "international_non_proprietary_name_common_name": "pomalidomide", "active_substance": "Pomalidomide", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "21/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/08/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "11/07/2018", "last_updated_date": "20/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imnovid" }, { "category": "Human", "name_of_medicine": "Hycamtin", "ema_product_number": "EMEA/H/C/000123", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000320277", "international_non_proprietary_name_common_name": "topotecan", "active_substance": "topotecan", "therapeutic_area_mesh": "Ovarian Neoplasms;Uterine Cervical Neoplasms;Small Cell Lung Carcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz Pharmaceuticals d.d.", "european_commission_decision_date": "20/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/07/1996", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/11/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "42", "first_published_date": "23/04/2018", "last_updated_date": "20/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hycamtin" }, { "category": "Human", "name_of_medicine": "Odomzo", "ema_product_number": "EMEA/H/C/002839", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000268112", "international_non_proprietary_name_common_name": "sonidegib", "active_substance": "sonidegib diphosphate", "therapeutic_area_mesh": "Carcinoma, Basal Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XJ02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "02/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/08/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "25/01/2018", "last_updated_date": "20/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/odomzo" }, { "category": "Human", "name_of_medicine": "Aflunov", "ema_product_number": "EMEA/H/C/002094", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0086", "international_non_proprietary_name_common_name": "zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)", "active_substance": "influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunisation against H5N1 subtype of Influenza A virus in individuals 6 months of age and above. Aflunov should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Seqirus S.r.l. ", "european_commission_decision_date": "21/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/11/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "19/05/2017", "last_updated_date": "20/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aflunov" }, { "category": "Human", "name_of_medicine": "Daptomycin Hospira", "ema_product_number": "EMEA/H/C/004310", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000323428", "international_non_proprietary_name_common_name": "daptomycin", "active_substance": "daptomycin", "therapeutic_area_mesh": "Soft Tissue Infections;Skin Diseases, Bacterial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01XX09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Daptomycin is indicated for the treatment of the following infections. Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It isrecommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI. Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "19/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/01/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/03/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "13/04/2018", "last_updated_date": "20/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/daptomycin-hospira" }, { "category": "Human", "name_of_medicine": "Degevma", "ema_product_number": "EMEA/H/C/006239", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Giant Cell Tumor of Bone;Neoplasms, Bone Tissue", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/09/2025", "last_updated_date": "20/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/degevma" }, { "category": "Human", "name_of_medicine": "Abiraterone Mylan", "ema_product_number": "EMEA/H/C/005368", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000319650", "international_non_proprietary_name_common_name": "abiraterone acetate", "active_substance": "abiraterone acetate", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy;Other hormone antagonists and related agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Abiraterone Mylan is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT). the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "19/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/06/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/08/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "26/08/2021", "last_updated_date": "19/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-mylan" }, { "category": "Human", "name_of_medicine": "Xenpozyme", "ema_product_number": "EMEA/H/C/004850", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000282268", "international_non_proprietary_name_common_name": "olipudase alfa", "active_substance": "olipudase alfa", "therapeutic_area_mesh": "Acid sphingomyelinase deficiency (ASMD) type A/B or type B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB25", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD) in paediatric and adult patients with type A/B or type B.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Sanofi B.V.", "european_commission_decision_date": "08/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/06/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "20/05/2022", "last_updated_date": "19/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xenpozyme" }, { "category": "Human", "name_of_medicine": "Effentora", "ema_product_number": "EMEA/H/C/000833", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000312945", "international_non_proprietary_name_common_name": "fentanyl", "active_substance": "fentanyl", "therapeutic_area_mesh": "Pain;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02AB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Phoenix Labs Unlimited Company", "european_commission_decision_date": "09/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/04/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "31/05/2018", "last_updated_date": "19/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/effentora" }, { "category": "Human", "name_of_medicine": "Brintellix", "ema_product_number": "EMEA/H/C/002717", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296460", "international_non_proprietary_name_common_name": "vortioxetine", "active_substance": "vortioxetine", "therapeutic_area_mesh": "Depressive Disorder, Major", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX26", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of major depressive episodes in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "H. Lundbeck A/S", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/10/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/12/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "18/07/2018", "last_updated_date": "19/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/brintellix" }, { "category": "Human", "name_of_medicine": "Opuviz", "ema_product_number": "EMEA/H/C/006056", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000280586", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications;Retinal Vein Occlusion", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Opuviz is indicated for adults for the treatment of: neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/11/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "20/09/2024", "last_updated_date": "19/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opuviz" }, { "category": "Human", "name_of_medicine": "Relistor", "ema_product_number": "EMEA/H/C/000870", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000323141", "international_non_proprietary_name_common_name": "methylnaltrexone bromide", "active_substance": "methylnaltrexone bromide", "therapeutic_area_mesh": "Opioid-Related Disorders;Constipation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A06AH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Peripheral opioid receptor antagonists", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bausch Health Ireland Limited", "european_commission_decision_date": "19/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/04/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/07/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "09/01/2017", "last_updated_date": "19/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/relistor" }, { "category": "Human", "name_of_medicine": "Skyrizi", "ema_product_number": "EMEA/H/C/004759", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296296", "international_non_proprietary_name_common_name": "risankizumab", "active_substance": "risankizumab", "therapeutic_area_mesh": "Psoriasis;Arthritis, Psoriatic;Colitis, Ulcerative;Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Plaque PsoriasisSkyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Psoriatic ArthritisSkyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Crohn’s diseaseSkyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. Ulcerative colitisSkyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "14/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/02/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/04/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "26/06/2019", "last_updated_date": "19/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/skyrizi" }, { "category": "Human", "name_of_medicine": "Tagrisso", "ema_product_number": "EMEA/H/C/004124", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310732", "international_non_proprietary_name_common_name": "osimertinib", "active_substance": "osimertinib mesilate", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antineoplastic agents;Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "TAGRISSO as monotherapy is indicated for: the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1). the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum‑based chemoradiation therapy. the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. TAGRISSO is indicated in combination with: pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "03/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/12/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/02/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "31/08/2018", "last_updated_date": "19/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tagrisso" }, { "category": "Human", "name_of_medicine": "Ziagen", "ema_product_number": "EMEA/H/C/000252", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296309", "international_non_proprietary_name_common_name": "abacavir", "active_substance": "abacavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children. The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy. Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare B.V.", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/03/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/07/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "50", "first_published_date": "01/03/2018", "last_updated_date": "19/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ziagen" }, { "category": "Human", "name_of_medicine": "Trizivir", "ema_product_number": "EMEA/H/C/000338", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296309", "international_non_proprietary_name_common_name": "abacavir;lamivudine;zidovudine", "active_substance": "abacavir (as sulfate);lamivudine;zidovudine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trizivir is indicated for the treatment of human-immunodeficiency-virus (HIV) infection in adults. This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar dosages. It is recommended that treatment is started with abacavir, lamivudine,and zidovudine separately for the first six to eight weeks. The choice of this fixed combination should be based not only on potential adherence criteria, but mainly on expected efficacy and risk related to the three nucleoside analogues. The demonstration of the benefit of Trizivir is mainly based on results of studies performed in treatment naive patients or moderately antiretroviral experienced patients with non-advanced disease. In patients with high viral load (>100,000 copies/ml) choice of therapy needs special consideration. Overall, the virologic suppression with this triple nucleoside regimen could be inferior to that obtained with other multitherapies notably including boosted protease inhibitors or non-nucleoside reverse-transcriptase inhibitors, therefore the use of Trizivir should only be considered under special circumstances (e.g. co-infection with tuberculosis). Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir (see 'management after an interruption of Trizivir therapy'). Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare BV", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/09/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/12/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "44", "first_published_date": "25/01/2018", "last_updated_date": "19/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trizivir" }, { "category": "Human", "name_of_medicine": "Kivexa", "ema_product_number": "EMEA/H/C/000581", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296309", "international_non_proprietary_name_common_name": "abacavir;lamivudine", "active_substance": "abacavir;lamivudine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for treatment of HIV infections, combinations;Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg. Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare BV", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/12/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "38", "first_published_date": "25/01/2018", "last_updated_date": "19/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kivexa" }, { "category": "Human", "name_of_medicine": "Aprovel", "ema_product_number": "EMEA/H/C/000141", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310720", "international_non_proprietary_name_common_name": "irbesartan", "active_substance": "irbesartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "51", "first_published_date": "02/08/2017", "last_updated_date": "19/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aprovel" }, { "category": "Human", "name_of_medicine": "Rystiggo", "ema_product_number": "EMEA/H/C/005824", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320683", "international_non_proprietary_name_common_name": "rozanolixizumab", "active_substance": "rozanolixizumab", "therapeutic_area_mesh": "Myasthenia Gravis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AL02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants;neonatal fragment crystallizable receptor (FcRn) inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rystiggo is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma", "european_commission_decision_date": "16/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/01/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "10/11/2023", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rystiggo" }, { "category": "Human", "name_of_medicine": "Namuscla", "ema_product_number": "EMEA/H/C/004584", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000295982", "international_non_proprietary_name_common_name": "mexiletine hcl", "active_substance": "Mexiletine hydrochloride", "therapeutic_area_mesh": "Myotonic Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Namuscla is indicated for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lupin Europe GmbH", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/12/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "01/02/2019", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/namuscla" }, { "category": "Human", "name_of_medicine": "Sugammadex Adroiq", "ema_product_number": "EMEA/H/C/006046", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000322606", "international_non_proprietary_name_common_name": "sugammadex", "active_substance": "sugammadex sodium", "therapeutic_area_mesh": "Neuromuscular Blockade", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AB35", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Extrovis EU Ltd", "european_commission_decision_date": "16/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "16/06/2023", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sugammadex-adroiq" }, { "category": "Human", "name_of_medicine": "Ervebo", "ema_product_number": "EMEA/H/C/004554", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000280470", "international_non_proprietary_name_common_name": "Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP, live)", "active_substance": "recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein", "therapeutic_area_mesh": "Hemorrhagic Fever, Ebola", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ervebo is indicated for active immunization of individuals 1 year of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus. The use of Ervebo should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/11/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "12/12/2019", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ervebo" }, { "category": "Human", "name_of_medicine": "Elrexfio", "ema_product_number": "EMEA/H/C/005908", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000294591", "international_non_proprietary_name_common_name": "elranatamab", "active_substance": "elranatamab", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Elrexfio is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "13/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/10/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/12/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "13/10/2023", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elrexfio" }, { "category": "Human", "name_of_medicine": "Intuniv", "ema_product_number": "EMEA/H/C/003759", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000269598", "international_non_proprietary_name_common_name": "guanfacine", "active_substance": "guanfacine hydrochloride", "therapeutic_area_mesh": "Attention Deficit Disorder with Hyperactivity", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02AC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives;Antiadrenergic agents, centrally acting", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland", "european_commission_decision_date": "11/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "16/10/2017", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/intuniv" }, { "category": "Human", "name_of_medicine": "Alimta", "ema_product_number": "EMEA/H/C/000564", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315508", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed", "therapeutic_area_mesh": "Mesothelioma;Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Malignant pleural mesothelioma Alimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma. Non-small-cell lung cancer Alimta in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology. Alimta is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Alimta is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "16/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "23/03/2018", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alimta" }, { "category": "Human", "name_of_medicine": "Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)", "ema_product_number": "EMEA/H/C/000783", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314724", "international_non_proprietary_name_common_name": "irbesartan;hydrochlorothiazide", "active_substance": "irbesartan;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "sanofi-aventis groupe ", "european_commission_decision_date": "16/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "28/08/2017", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/irbesartan-hydrochlorothiazide-zentiva" }, { "category": "Human", "name_of_medicine": "Xospata", "ema_product_number": "EMEA/H/C/004752", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0017", "international_non_proprietary_name_common_name": "gilteritinib", "active_substance": "gilteritinib fumarate", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma Europe B.V.", "european_commission_decision_date": "27/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/10/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "08/11/2019", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xospata" }, { "category": "Human", "name_of_medicine": "Karvea", "ema_product_number": "EMEA/H/C/000142", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310720", "international_non_proprietary_name_common_name": "irbesartan", "active_substance": "irbesartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal product regimen.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "49", "first_published_date": "02/08/2017", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/karvea" }, { "category": "Human", "name_of_medicine": "Tauvid", "ema_product_number": "EMEA/H/C/006064", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315508", "international_non_proprietary_name_common_name": "flortaucipir (18F)", "active_substance": "Flortaucipir (18F)", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Flortaucipir (18F) is a radiopharmaceutical indicated for positron emission tomography (PET) imaging of the brain to assess the neocortical distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD). Flortaucipir (18F) is an adjunct to clinical and other diagnostic evaluations. For limitations of use, see sections 4.4 and 5.1.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "16/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "28/06/2024", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tauvid" }, { "category": "Human", "name_of_medicine": "Cyramza", "ema_product_number": "EMEA/H/C/002829", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315508", "international_non_proprietary_name_common_name": "ramucirumab", "active_substance": "ramucirumab", "therapeutic_area_mesh": "Stomach Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy. Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate. Colorectal cancer Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5?fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. Non-small cell lung cancer Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy. Hepatocellular carcinoma Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ? 400 ng/ml and who have been previously treated with sorafenib.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "16/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/12/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "12/02/2018", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cyramza" }, { "category": "Human", "name_of_medicine": "Amyvid", "ema_product_number": "EMEA/H/C/002422", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315508", "international_non_proprietary_name_common_name": "florbetapir (18F)", "active_substance": "florbetapir (18F)", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09AX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of ?-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "16/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/01/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "04/06/2018", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amyvid" }, { "category": "Human", "name_of_medicine": "Abiraterone Krka", "ema_product_number": "EMEA/H/C/005649", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000284809", "international_non_proprietary_name_common_name": "abiraterone acetate", "active_substance": "abiraterone acetate", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Abiraterone Krka is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1) the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/06/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "23/11/2021", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-krka" }, { "category": "Human", "name_of_medicine": "Victoza", "ema_product_number": "EMEA/H/C/001026", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00001892/202312", "international_non_proprietary_name_common_name": "liraglutide", "active_substance": "liraglutide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Victoza is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "19/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/06/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "22/09/2017", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/victoza" }, { "category": "Human", "name_of_medicine": "Ifirmacombi", "ema_product_number": "EMEA/H/C/002302", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308442", "international_non_proprietary_name_common_name": "irbesartan;hydrochlorothiazide", "active_substance": "irbesartan;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/03/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "20/12/2017", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ifirmacombi" }, { "category": "Human", "name_of_medicine": "Irbesartan/Hydrochlorothiazide Teva", "ema_product_number": "EMEA/H/C/001112", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000304050", "international_non_proprietary_name_common_name": "irbesartan;hydrochlorothiazide", "active_substance": "irbesartan;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V. ", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/11/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "07/11/2017", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/irbesartan-hydrochlorothiazide-teva" }, { "category": "Human", "name_of_medicine": "Rivastigmine 1 A Pharma", "ema_product_number": "EMEA/H/C/001181", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000301284", "international_non_proprietary_name_common_name": "rivastigmine", "active_substance": "rivastigmine", "therapeutic_area_mesh": "Alzheimer Disease;Dementia;Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "1 A Pharma GmbH", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/12/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "16/08/2016", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rivastigmine-1-pharma" }, { "category": "Human", "name_of_medicine": "Rivastigmine Sandoz", "ema_product_number": "EMEA/H/C/001183", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000301284", "international_non_proprietary_name_common_name": "rivastigmine", "active_substance": "rivastigmine", "therapeutic_area_mesh": "Dementia;Alzheimer Disease;Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/12/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "16/08/2016", "last_updated_date": "16/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rivastigmine-sandoz" }, { "category": "Human", "name_of_medicine": "Pemetrexed Pfizer (previously Pemetrexed Hospira)", "ema_product_number": "EMEA/H/C/003970", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000323208", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed disodium;pemetrexed disodium hemipentahydrate", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Mesothelioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Malignant pleural mesothelioma Pemetrexed Pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "24/04/2018", "last_updated_date": "15/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-pfizer" }, { "category": "Human", "name_of_medicine": "Verkazia", "ema_product_number": "EMEA/H/C/004411", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0021", "international_non_proprietary_name_common_name": "ciclosporin", "active_substance": "ciclosporin", "therapeutic_area_mesh": "Conjunctivitis;Keratitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Santen Oy", "european_commission_decision_date": "31/03/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/07/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "06/07/2018", "last_updated_date": "15/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/verkazia" }, { "category": "Human", "name_of_medicine": "Ikervis", "ema_product_number": "EMEA/H/C/002066", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0035", "international_non_proprietary_name_common_name": "ciclosporin", "active_substance": "ciclosporin", "therapeutic_area_mesh": "Corneal Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Santen Oy", "european_commission_decision_date": "27/02/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/03/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "09/01/2017", "last_updated_date": "15/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ikervis" }, { "category": "Human", "name_of_medicine": "Rhokiinsa", "ema_product_number": "EMEA/H/C/004583", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000274637", "international_non_proprietary_name_common_name": "netarsudil", "active_substance": "netarsudil", "therapeutic_area_mesh": "Glaucoma, Open-Angle;Ocular Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01EX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Santen Oy", "european_commission_decision_date": "09/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "03/12/2019", "last_updated_date": "15/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rhokiinsa" }, { "category": "Human", "name_of_medicine": "Bekemv", "ema_product_number": "EMEA/H/C/005652", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000322712", "international_non_proprietary_name_common_name": "eculizumab", "active_substance": "Eculizumab", "therapeutic_area_mesh": "Hemoglobinuria, Paroxysmal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AJ01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Technology (Ireland) UC", "european_commission_decision_date": "15/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "21/02/2023", "last_updated_date": "15/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bekemv" }, { "category": "Human", "name_of_medicine": "Blincyto", "ema_product_number": "EMEA/H/C/003731", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000286935", "international_non_proprietary_name_common_name": "blinatumomab", "active_substance": "blinatumomab", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with Philadelphia chromosome-negative CD19 positive B‑cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy (see section 4.2). Blincyto is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "18/06/2018", "last_updated_date": "15/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/blincyto" }, { "category": "Human", "name_of_medicine": "Roctavian", "ema_product_number": "EMEA/H/C/005830", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000309039", "international_non_proprietary_name_common_name": "valoctocogene roxaparvovec", "active_substance": "valoctocogene roxaparvovec", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of severe haemophilia A (congenital factor VIII deficiency) in adult patients without a history of factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "BioMarin International Limited", "european_commission_decision_date": "11/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/08/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "20/06/2022", "last_updated_date": "14/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/roctavian" }, { "category": "Human", "name_of_medicine": "Zvogra", "ema_product_number": "EMEA/H/C/006552", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000318927", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Giant Cell Tumor of Bone;Neoplasms, Bone Tissue", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1). Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stada Arzneimittel AG", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "19/09/2025", "last_updated_date": "14/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zvogra" }, { "category": "Human", "name_of_medicine": "Abiraterone Accord", "ema_product_number": "EMEA/H/C/005408", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000286405", "international_non_proprietary_name_common_name": "abiraterone", "active_substance": "abiraterone acetate", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Abiraterone Accord is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "19/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/02/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/04/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "05/05/2021", "last_updated_date": "14/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-accord" }, { "category": "Human", "name_of_medicine": "Stoboclo", "ema_product_number": "EMEA/H/C/006156", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320514", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal;Osteoporosis;Bone Resorption", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "14/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "13/12/2024", "last_updated_date": "14/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/stoboclo" }, { "category": "Human", "name_of_medicine": "Rydapt", "ema_product_number": "EMEA/H/C/004095", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320179", "international_non_proprietary_name_common_name": "midostaurin", "active_substance": "Midostaurin", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute;Mastocytosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rydapt is indicated: in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive (see section 4.2); as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM AHN), or mast cell leukaemia (MCL).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd", "european_commission_decision_date": "13/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/06/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "30/04/2018", "last_updated_date": "14/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rydapt" }, { "category": "Human", "name_of_medicine": "Aranesp", "ema_product_number": "EMEA/H/C/000332", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000267359", "international_non_proprietary_name_common_name": "darbepoetin alfa", "active_substance": "darbepoetin alfa", "therapeutic_area_mesh": "Anemia;Cancer;Kidney Failure, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "01/05/2001", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/06/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "47", "first_published_date": "20/06/2018", "last_updated_date": "13/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aranesp" }, { "category": "Human", "name_of_medicine": "Welireg", "ema_product_number": "EMEA/H/C/005636", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000290222", "international_non_proprietary_name_common_name": "belzutifan", "active_substance": "belzutifan", "therapeutic_area_mesh": "Carcinoma, Renal Cell;von Hippel-Lindau Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX74", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Renal cell carcinoma (RCC) Welireg is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies. von Hippel-Lindau (VHL) disease-associated tumours Welireg is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "08/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "13/12/2024", "last_updated_date": "13/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/welireg" }, { "category": "Human", "name_of_medicine": "Mavenclad", "ema_product_number": "EMEA/H/C/004230", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316384", "international_non_proprietary_name_common_name": "cladribine", "active_substance": "cladribine", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA40", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Europe B.V.", "european_commission_decision_date": "10/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/06/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "09/07/2018", "last_updated_date": "13/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mavenclad" }, { "category": "Human", "name_of_medicine": "Inrebic", "ema_product_number": "EMEA/H/C/005026", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000264185", "international_non_proprietary_name_common_name": "fedratinib", "active_substance": "fedratinib dihydrochloride monohydrate", "therapeutic_area_mesh": "Myeloproliferative Disorders;Primary Myelofibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EJ02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol Myers Squibb Pharma EEIG", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "03/03/2021", "last_updated_date": "13/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/inrebic" }, { "category": "Human", "name_of_medicine": "GalenVita", "ema_product_number": "EMEA/H/C/006639", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "germanium (68Ge) chloride;gallium (68Ga) chloride", "active_substance": "germanium (68Ge) chloride;gallium (68Ga) chloride", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This radionuclide generator is not intended for direct use in patients. The sterile eluate (gallium (68Ga) chloride solution) from the radionuclide generator GalenVita is indicated for in vitro radiolabelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling with such eluate, to be used for positron emission tomography (PET) imaging.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Curium Romania S.R.L.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2026", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/11/2025", "last_updated_date": "13/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/galenvita" }, { "category": "Human", "name_of_medicine": "Voydeya", "ema_product_number": "EMEA/H/C/005517", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000317168", "international_non_proprietary_name_common_name": "danicopan", "active_substance": "danicopan", "therapeutic_area_mesh": "Hemoglobinuria, Paroxysmal;Hemolysis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AJ09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants, Complement inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Voydeya is indicated as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Alexion Europe SAS", "european_commission_decision_date": "12/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "23/02/2024", "last_updated_date": "13/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/voydeya" }, { "category": "Human", "name_of_medicine": "Entresto", "ema_product_number": "EMEA/H/C/004062", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319973", "international_non_proprietary_name_common_name": "sacubitril;valsartan", "active_substance": "sacubitril;valsartan", "therapeutic_area_mesh": "Heart Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Angiotensin II antagonists, other combinations;Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Paediatric heart failure Entresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction. Adult heart failure Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "12/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "22/06/2018", "last_updated_date": "13/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/entresto" }, { "category": "Human", "name_of_medicine": "Neparvis", "ema_product_number": "EMEA/H/C/004343", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319973", "international_non_proprietary_name_common_name": "sacubitril;valsartan", "active_substance": "sacubitril;valsartan", "therapeutic_area_mesh": "Heart Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Paediatric heart failure Neparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5.1). Adult heart failure Neparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "12/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/03/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "22/06/2018", "last_updated_date": "13/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neparvis" }, { "category": "Human", "name_of_medicine": "Celsentri", "ema_product_number": "EMEA/H/C/000811", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000295718", "international_non_proprietary_name_common_name": "maraviroc", "active_substance": "maraviroc", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only CCR5-tropic HIV-1 detectable", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare B.V.", "european_commission_decision_date": "20/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/07/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "12/04/2018", "last_updated_date": "12/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/celsentri" }, { "category": "Human", "name_of_medicine": "Bosulif", "ema_product_number": "EMEA/H/C/002373", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319527", "international_non_proprietary_name_common_name": "bosutinib", "active_substance": "bosutinib (as monohydrate)", "therapeutic_area_mesh": "Leukemia, Myeloid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bosulif is indicated for the treatment of:• Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).• Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.• Adult patients with accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "11/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/01/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/03/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "02/08/2018", "last_updated_date": "12/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bosulif" }, { "category": "Human", "name_of_medicine": "Abilify", "ema_product_number": "EMEA/H/C/000471", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000313289", "international_non_proprietary_name_common_name": "aripiprazole", "active_substance": "aripiprazole", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Otsuka Pharmaceutical Netherlands B.V.", "european_commission_decision_date": "09/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2004", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/06/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "50", "first_published_date": "26/03/2018", "last_updated_date": "12/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abilify" }, { "category": "Human", "name_of_medicine": "Xeljanz", "ema_product_number": "EMEA/H/C/004214", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296118", "international_non_proprietary_name_common_name": "tofacitinib", "active_substance": "tofacitinib", "therapeutic_area_mesh": "Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AF01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritisTofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) (see section 5.1). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5). Psoriatic arthritisTofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy (see section 5.1). Ulcerative colitisTofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1). Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs). Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Ankylosing spondylitisTofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/01/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/03/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "25/06/2018", "last_updated_date": "12/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xeljanz" }, { "category": "Human", "name_of_medicine": "Usymro", "ema_product_number": "EMEA/H/C/006467", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000316073", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Crohn Disease;Psoriasis;Arthritis, Psoriatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Plaque psoriasis Usymro is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A). Paediatric plaque psoriasis Usymro is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Usymro, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Adult Crohn’s disease Usymro is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Paediatric Crohn’s disease Usymro is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighting at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "09/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/06/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "20/06/2025", "last_updated_date": "09/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/usymro" }, { "category": "Human", "name_of_medicine": "Bilprevda", "ema_product_number": "EMEA/H/C/006435", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316447", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Giant Cell Tumor of Bone;Neoplasms, Bone Tissue", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sciencepharma Sp. z o.o", "european_commission_decision_date": "08/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "25/07/2025", "last_updated_date": "09/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bilprevda" }, { "category": "Human", "name_of_medicine": "Tolvaptan Accord", "ema_product_number": "EMEA/H/C/005961", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000317240", "international_non_proprietary_name_common_name": "tolvaptan", "active_substance": "tolvaptan", "therapeutic_area_mesh": "Inappropriate ADH Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C03XA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diuretics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "09/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/01/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "24/01/2023", "last_updated_date": "09/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tolvaptan-accord" }, { "category": "Human", "name_of_medicine": "Onureg", "ema_product_number": "EMEA/H/C/004761", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000289529", "international_non_proprietary_name_common_name": "azacitidine", "active_substance": "azacitidine", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "08/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/06/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "20/04/2021", "last_updated_date": "09/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/onureg" }, { "category": "Human", "name_of_medicine": "Praluent", "ema_product_number": "EMEA/H/C/003882", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000295839", "international_non_proprietary_name_common_name": "alirocumab", "active_substance": "alirocumab", "therapeutic_area_mesh": "Dyslipidemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Primary hypercholesterolaemia and mixed dyslipidaemia Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Established atherosclerotic cardiovascular disease Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: - in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "17/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/09/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "25/06/2018", "last_updated_date": "09/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/praluent" }, { "category": "Human", "name_of_medicine": "Ayvakyt", "ema_product_number": "EMEA/H/C/005208", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000275571", "international_non_proprietary_name_common_name": "avapritinib", "active_substance": "avapritinib", "therapeutic_area_mesh": "Gastrointestinal Stromal Tumors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antineoplastic agents;Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Unresectable or metastatic gastrointestinal stromal tumour (GIST) AYVAKYT is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation. Advanced systemic mastocytosis (AdvSM) AYVAKYT is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy. Indolent systemic mastocytosis (ISM) AYVAKYT is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Blueprint Medicines (Netherlands) B.V.", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/09/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "30/09/2020", "last_updated_date": "09/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ayvakyt" }, { "category": "Human", "name_of_medicine": "Nurzigma", "ema_product_number": "EMEA/H/C/006261", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pridopidine", "active_substance": "pridopidine hydrochloride", "therapeutic_area_mesh": "Huntington Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Huntington's disease ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Prilenia Therapeutics B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "07/11/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/07/2025", "last_updated_date": "09/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nurzigma" }, { "category": "Human", "name_of_medicine": "Harvoni", "ema_product_number": "EMEA/H/C/003850", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/2356", "international_non_proprietary_name_common_name": "ledispavir;sofosbuvir", "active_substance": "ledipasvir;sofosbuvir", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX65", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "12/01/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "07/06/2018", "last_updated_date": "09/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/harvoni" }, { "category": "Human", "name_of_medicine": "Sovaldi", "ema_product_number": "EMEA/H/C/002798", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/2356", "international_non_proprietary_name_common_name": "sofosbuvir", "active_substance": "sofosbuvir", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1. Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "12/01/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/11/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "06/08/2018", "last_updated_date": "09/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sovaldi" }, { "category": "Human", "name_of_medicine": "Rimmyrah", "ema_product_number": "EMEA/H/C/006055", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314772", "international_non_proprietary_name_common_name": "ranibizumab", "active_substance": "ranibizumab", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications;Myopia, Degenerative;Choroidal Neovascularization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineovascularisation agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rimmyrah is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative diabetic retinopathy (PDR) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) The treatment of visual impairment due to choroidal neovascularisation (CNV)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Qilu Pharma Spain S.L.", "european_commission_decision_date": "09/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/01/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "10/11/2023", "last_updated_date": "09/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rimmyrah" }, { "category": "Veterinary", "name_of_medicine": "Ecovaxxin MS", "ema_product_number": "EMEA/V/C/006604", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Mycoplasma synoviae, strain K588A, Live", "active_substance": "Mycoplasma synoviae, strain K588A, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Live bacterial vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "07/11/2025", "last_updated_date": "08/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/ecovaxxin-ms" }, { "category": "Human", "name_of_medicine": "Reagila", "ema_product_number": "EMEA/H/C/002770", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000320177", "international_non_proprietary_name_common_name": "cariprazine", "active_substance": "cariprazine hydrochloride", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reagila is indicated for the treatment of schizophrenia in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter", "european_commission_decision_date": "08/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/05/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "07/05/2018", "last_updated_date": "08/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/reagila" }, { "category": "Human", "name_of_medicine": "Xalkori", "ema_product_number": "EMEA/H/C/002489", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000317352", "international_non_proprietary_name_common_name": "crizotinib", "active_substance": "crizotinib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01ED01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xalkori as monotherapy is indicated for: The first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with ROS1 positive advanced non small cell lung cancer (NSCLC) The treatment of paediatric patients (age 1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL) The treatment of paediatric patients (age 1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "05/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/07/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/10/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "40", "first_published_date": "31/08/2018", "last_updated_date": "08/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xalkori" }, { "category": "Human", "name_of_medicine": "Cancidas (previously Caspofungin MSD)", "ema_product_number": "EMEA/H/C/000379", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315850", "international_non_proprietary_name_common_name": "caspofungin", "active_substance": "caspofungin (as acetate)", "therapeutic_area_mesh": "Candidiasis;Aspergillosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of invasive candidiasis in adult or paediatric patients; treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and / or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy; empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "05/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/07/2001", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/10/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "15/02/2017", "last_updated_date": "08/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cancidas" }, { "category": "Human", "name_of_medicine": "Wayrilz", "ema_product_number": "EMEA/H/C/006425", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rilzabrutinib", "active_substance": "rilzabrutinib", "therapeutic_area_mesh": "Purpura, Thrombocytopenic, Idiopathic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "Not yet assigned", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Not assigned yet", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Wayrilz is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (see section 5.1)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/10/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/12/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/10/2025", "last_updated_date": "08/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/wayrilz" }, { "category": "Human", "name_of_medicine": "Cabazitaxel Accord", "ema_product_number": "EMEA/H/C/005178", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320820", "international_non_proprietary_name_common_name": "cabazitaxel", "active_substance": "cabazitaxel", "therapeutic_area_mesh": "Prostatic Neoplasms, Castration-Resistant", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "07/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/04/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/08/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "28/10/2020", "last_updated_date": "07/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cabazitaxel-accord" }, { "category": "Human", "name_of_medicine": "Olanzapine Viatris (previously Olanzapine Mylan)", "ema_product_number": "EMEA/H/C/000961", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000317950", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "07/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/10/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "12/12/2017", "last_updated_date": "07/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/olanzapine-viatris" }, { "category": "Human", "name_of_medicine": "Norvir", "ema_product_number": "EMEA/H/C/000127", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249795", "international_non_proprietary_name_common_name": "ritonavir", "active_substance": "ritonavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1-infected patients (adults and children of two years of age and older).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "03/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/05/1996", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/08/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "72", "first_published_date": "24/05/2018", "last_updated_date": "07/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/norvir" }, { "category": "Veterinary", "name_of_medicine": "Vaxxinact H5", "ema_product_number": "EMEA/V/C/006717", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Avian influenza virus, subtype H5, haemagglutinin (recombinant)", "active_substance": "Avian influenza virus, subtype H5, haemagglutinin (recombinant)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "07/11/2025", "last_updated_date": "07/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vaxxinact-h5" }, { "category": "Human", "name_of_medicine": "Voraxaze", "ema_product_number": "EMEA/H/C/005467", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314574", "international_non_proprietary_name_common_name": "glucarpidase", "active_substance": "glucarpidase", "therapeutic_area_mesh": "Metabolic Side Effects of Drugs and Substances", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AF09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Voraxaze is indicated to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SERB SAS", "european_commission_decision_date": "05/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/11/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "14/09/2021", "last_updated_date": "07/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/voraxaze" }, { "category": "Human", "name_of_medicine": "Kuvan", "ema_product_number": "EMEA/H/C/000943", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320742", "international_non_proprietary_name_common_name": "sapropterin", "active_substance": "sapropterin dihydrochloride", "therapeutic_area_mesh": "Phenylketonurias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kuvan is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment. Kuvan is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioMarin International Limited", "european_commission_decision_date": "07/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/12/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "12/04/2018", "last_updated_date": "07/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kuvan" }, { "category": "Human", "name_of_medicine": "Obodence", "ema_product_number": "EMEA/H/C/006424", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319278", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal;Osteoporosis;Bone Resorption", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "05/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "15/11/2024", "last_updated_date": "06/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/obodence" }, { "category": "Human", "name_of_medicine": "Tyverb", "ema_product_number": "EMEA/H/C/000795", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000320526", "international_non_proprietary_name_common_name": "lapatinib", "active_substance": "lapatinib", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting; in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy; in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "05/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/06/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "30/07/2018", "last_updated_date": "06/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tyverb" }, { "category": "Human", "name_of_medicine": "Imlygic", "ema_product_number": "EMEA/H/C/002771", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000316733", "international_non_proprietary_name_common_name": "talimogene laherparepvec", "active_substance": "talimogene laherparepvec", "therapeutic_area_mesh": "Melanoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX51", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "22/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/12/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "04/06/2018", "last_updated_date": "06/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imlygic" }, { "category": "Human", "name_of_medicine": "Ofev", "ema_product_number": "EMEA/H/C/003821", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000304681", "international_non_proprietary_name_common_name": "nintedanib", "active_substance": "nintedanib", "therapeutic_area_mesh": "Idiopathic Pulmonary Fibrosis;Lung Diseases, Interstitial;Pulmonary Fibrosis;Scleroderma, Systemic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "05/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/01/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "26/07/2018", "last_updated_date": "06/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ofev" }, { "category": "Human", "name_of_medicine": "Spedra", "ema_product_number": "EMEA/H/C/002581", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319544", "international_non_proprietary_name_common_name": "avanafil", "active_substance": "avanafil", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in erectile dysfunction", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Menarini International Operations Luxembourg S.A.", "european_commission_decision_date": "05/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/06/2013", "refusal_of_marketing_authorisation_date": "26/04/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "23/04/2018", "last_updated_date": "06/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/spedra" }, { "category": "Human", "name_of_medicine": "Vabysmo", "ema_product_number": "EMEA/H/C/005642", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000288096", "international_non_proprietary_name_common_name": "faricimab", "active_substance": "Faricimab", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01L", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vabysmo is indicated for the treatment of adult patients with: neovascular (wet) age-related macular degeneration (nAMD), visual impairment due to diabetic macular oedema (DME), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "11/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "19/07/2022", "last_updated_date": "06/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vabysmo" }, { "category": "Human", "name_of_medicine": "Veklury", "ema_product_number": "EMEA/H/C/005622", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314055", "international_non_proprietary_name_common_name": "remdesivir", "active_substance": "remdesivir", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AB16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Veklury is indicated for the treatment of coronavirus disease 2019 (COVID 19) in adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg):  with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 (see section 5.1)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "22/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/07/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "06/07/2020", "last_updated_date": "06/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/veklury" }, { "category": "Human", "name_of_medicine": "Vaxneuvance", "ema_product_number": "EMEA/H/C/005477", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308795", "international_non_proprietary_name_common_name": "pneumococcal polysaccharide conjugate vaccine (adsorbed)", "active_substance": "pneumococcal polysaccharide conjugate vaccine (adsorbed)", "therapeutic_area_mesh": "Pneumococcal Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AL02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "pneumococcus, purified polysaccharides antigen conjugated", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. Vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Vaxneuvance should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "10/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/10/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/12/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "12/10/2021", "last_updated_date": "06/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vaxneuvance" }, { "category": "Human", "name_of_medicine": "Voriconazole Hikma (previously Voriconazole Hospira)", "ema_product_number": "EMEA/H/C/003737", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310244", "international_non_proprietary_name_common_name": "voriconazole", "active_substance": "voriconazole", "therapeutic_area_mesh": "Bacterial Infections and Mycoses;Aspergillosis;Candidiasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT)recipients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Hikma Farmaceutica (Portugal) S.A.", "european_commission_decision_date": "22/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/05/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "20/09/2017", "last_updated_date": "06/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/voriconazole-hikma" }, { "category": "Human", "name_of_medicine": "Levetiracetam Sun", "ema_product_number": "EMEA/H/C/002051", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000317912", "international_non_proprietary_name_common_name": "levetiracetam", "active_substance": "levetiracetam", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Levetiracetam Sun is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Sun is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four years of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. Levetiracetam Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "22/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/10/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/12/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "24/07/2018", "last_updated_date": "05/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-sun" }, { "category": "Human", "name_of_medicine": "Jalra", "ema_product_number": "EMEA/H/C/001048", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308306", "international_non_proprietary_name_common_name": "vildagliptin", "active_substance": "vildagliptin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BH02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Dipeptidyl peptidase 4 (DPP-4) inhibitors;Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "05/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/09/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "26/04/2018", "last_updated_date": "05/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jalra" }, { "category": "Human", "name_of_medicine": "Junod", "ema_product_number": "EMEA/H/C/006436", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000300682", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Junod significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Junod significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "22/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/04/2025", "last_updated_date": "05/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/junod" }, { "category": "Human", "name_of_medicine": "Telzir", "ema_product_number": "EMEA/H/C/000534", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG1531", "international_non_proprietary_name_common_name": "fosamprenavir", "active_substance": "fosamprenavir calcium", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Telzir in combination with low-dose ritonavir is indicated for the treatment of human-immunodeficiency-virus-type-1-infected adults, adolescents and children of six years and above in combination with other antiretroviral medicinal products. In moderately antiretroviral-experienced adults, Telzir in combination with low-dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. No comparative studies have been undertaken in children or adolescents. In heavily pretreated patients, the use of Telzir in combination with low-dose ritonavir has not been sufficiently studied. In protease-inhibitor-experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare BV", "european_commission_decision_date": "19/08/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/07/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "21/11/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "48", "first_published_date": "10/03/2017", "last_updated_date": "05/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/telzir" }, { "category": "Human", "name_of_medicine": "Granupas (previously Para-aminosalicylic acid Lucane)", "ema_product_number": "EMEA/H/C/002709", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0043", "international_non_proprietary_name_common_name": "para-aminosalicylic acid", "active_substance": "para-aminosalicylic acid", "therapeutic_area_mesh": "Tuberculosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J04AA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycobacterials", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Granupas is indicated for use as part of an appropriate combination regimen for multi-drug resistant tuberculosis in adults and paediatric patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see section 4.4). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eurocept International B. V.", "european_commission_decision_date": "14/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/11/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/04/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "04/12/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "29/06/2018", "last_updated_date": "05/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/granupas" }, { "category": "Human", "name_of_medicine": "Xiliarx", "ema_product_number": "EMEA/H/C/001051", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308306", "international_non_proprietary_name_common_name": "vildagliptin", "active_substance": "vildagliptin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BH02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "05/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "26/04/2018", "last_updated_date": "05/01/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xiliarx" }, { "category": "Human", "name_of_medicine": "Tasigna", "ema_product_number": "EMEA/H/C/000798", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000318973", "international_non_proprietary_name_common_name": "nilotinib", "active_substance": "nilotinib", "therapeutic_area_mesh": "Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib. Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "17/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "48", "first_published_date": "15/11/2017", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tasigna" }, { "category": "Human", "name_of_medicine": "Fabhalta", "ema_product_number": "EMEA/H/C/005764", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319878", "international_non_proprietary_name_common_name": "iptacopan", "active_substance": "iptacopan hydrochloride monohydrate", "therapeutic_area_mesh": "Hemoglobinuria, Paroxysmal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04A", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Paroxysmal nocturnal haemoglobinuria Fabhalta is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. Complement 3 glomerulopathy Fabhalta is indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "19/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/05/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "14/06/2024", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fabhalta" }, { "category": "Human", "name_of_medicine": "Attrogy", "ema_product_number": "EMEA/H/C/006248", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000301554", "international_non_proprietary_name_common_name": "diflunisal", "active_substance": "diflunisal", "therapeutic_area_mesh": "Amyloid Neuropathies, Familial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02BA11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other analgesics and antipyretics;Salicylic acid and derivatives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Attrogy is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Purpose Pharma International AB", "european_commission_decision_date": "11/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/07/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/04/2025", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/attrogy" }, { "category": "Human", "name_of_medicine": "Replagal", "ema_product_number": "EMEA/H/C/000369", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310907", "international_non_proprietary_name_common_name": "agalsidase alfa", "active_substance": "agalsidase alfa", "therapeutic_area_mesh": "Fabry Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland Branch", "european_commission_decision_date": "17/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/03/2001", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/08/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "21/11/2017", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/replagal" }, { "category": "Human", "name_of_medicine": "Tuzulby", "ema_product_number": "EMEA/H/C/005975", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314054", "international_non_proprietary_name_common_name": "methylphenidate hydrochloride", "active_substance": "methylphenidate hydrochloride", "therapeutic_area_mesh": "Attention Deficit Disorder with Hyperactivity", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tuzulby is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children and adolescents 6-17 years old when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria or the guidelines in International Classification of Diseases, Tenth Revision (ICD-10) and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Neuraxpharm Pharmaceuticals S.L.", "european_commission_decision_date": "19/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "13/12/2024", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tuzulby" }, { "category": "Human", "name_of_medicine": "Leflunomide medac", "ema_product_number": "EMEA/H/C/001227", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315571", "international_non_proprietary_name_common_name": "leflunomide", "active_substance": "leflunomide", "therapeutic_area_mesh": "Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AK01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Selective immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD). Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "european_commission_decision_date": "19/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/07/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "30/01/2018", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/leflunomide-medac" }, { "category": "Human", "name_of_medicine": "Yargesa", "ema_product_number": "EMEA/H/C/004016", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310253", "international_non_proprietary_name_common_name": "miglustat", "active_substance": "miglustat", "therapeutic_area_mesh": "Gaucher Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Yargesa is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Yargesa is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Piramal Critical Care B.V.", "european_commission_decision_date": "19/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/01/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/03/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "10/05/2017", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yargesa" }, { "category": "Human", "name_of_medicine": "Simulect", "ema_product_number": "EMEA/H/C/000207", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319153", "international_non_proprietary_name_common_name": "basiliximab", "active_substance": "basiliximab", "therapeutic_area_mesh": "Graft Rejection;Kidney Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Simulect is indicated for the prophylaxis of acute organ rejection in de-novo allogeneic renal transplantation in adult and paediatric patients (1-17 years). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/10/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "12/04/2018", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/simulect" }, { "category": "Human", "name_of_medicine": "Macitentan AccordPharma", "ema_product_number": "EMEA/H/C/006523", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "macitentan", "active_substance": "macitentan", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "AdultsMacitentan AccordPharma, as monotherapy or in combination, is indicated for the long-term treatmentof pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III (seesection 5.1)Paediatric populationMacitentan AccordPharma, as monotherapy or in combination, is indicated for the long-term treatmentof pulmonary arterial hypertension (PAH) in paediatric patients aged less than 18 years andbodyweight ≥ 40 kg with WHO Functional Class (FC) II to III (see section 5.1)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/09/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/07/2025", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/macitentan-accordpharma" }, { "category": "Human", "name_of_medicine": "Methylthioninium chloride Proveblue", "ema_product_number": "EMEA/H/C/002108", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000265559", "international_non_proprietary_name_common_name": "methylthioninium chloride", "active_substance": "methylthioninium chloride", "therapeutic_area_mesh": "Methemoglobinemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AB17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Acute symptomatic treatment of medicinal and chemical products- induced methaemoglobinaemia. Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Provepharm SAS", "european_commission_decision_date": "02/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/05/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "06/04/2018", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/methylthioninium-chloride-proveblue" }, { "category": "Human", "name_of_medicine": "Altuvoct", "ema_product_number": "EMEA/H/C/005968", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000274459", "international_non_proprietary_name_common_name": "efanesoctocog alfa", "active_substance": "Efanesoctocog alfa", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Altuvoct can be used for all age groups.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Swedish Orphan Biovitrum AB (publ)", "european_commission_decision_date": "12/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/06/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "26/04/2024", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/altuvoct" }, { "category": "Human", "name_of_medicine": "Pirfenidone Viatris", "ema_product_number": "EMEA/H/C/005862", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000319085", "international_non_proprietary_name_common_name": "pirfenidone", "active_substance": "Pirfenidone", "therapeutic_area_mesh": "Idiopathic Pulmonary Fibrosis;Lung Diseases;Respiratory Tract Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/01/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "04/11/2022", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pirfenidone-viatris" }, { "category": "Human", "name_of_medicine": "Macitentan Accord", "ema_product_number": "EMEA/H/C/006524", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "macitentan", "active_substance": "macitentan", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "AdultsMacitentan Accord as monotherapy is indicated for the long-term treatment of pulmonary arterialhypertension (PAH) in adult patients of WHO Functional Class (FC) II to III (see section 5.1). Paediatric populationMacitentan Accord as monotherapy is indicated for the long-term treatment of pulmonary arterialhypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥ 40 kg with WHOFunctional Class (FC) II to III (see section 5.1). ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/09/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/07/2025", "last_updated_date": "19/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/macitentan-accord" }, { "category": "Human", "name_of_medicine": "Puregon", "ema_product_number": "EMEA/H/C/000086", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316030", "international_non_proprietary_name_common_name": "follitropin beta", "active_substance": "follitropin beta", "therapeutic_area_mesh": "Infertility;Hypogonadism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03GA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "In the female: Puregon is indicated for the treatment of female infertility in the following clinical situations: anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate; controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in-vitro fertilisation / embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/12/1995", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/05/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "06/07/2018", "last_updated_date": "18/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/puregon" }, { "category": "Human", "name_of_medicine": "Fetcroja", "ema_product_number": "EMEA/H/C/004829", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0022", "international_non_proprietary_name_common_name": "cefiderocol", "active_substance": "cefiderocol sulfate tosilate", "therapeutic_area_mesh": "Gram-Negative Bacterial Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01D", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fetcroja is indicated for the treatment of infections   due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Shionogi B.V.", "european_commission_decision_date": "13/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "29/04/2020", "last_updated_date": "18/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fetcroja" }, { "category": "Human", "name_of_medicine": "RotaTeq", "ema_product_number": "EMEA/H/C/000669", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000301699", "international_non_proprietary_name_common_name": "rotavirus vaccine, live", "active_substance": "rotavirus serotype G1;rotavirus serotype G2;rotavirus serotype G3;rotavirus serotype G4;rotavirus serotype P1", "therapeutic_area_mesh": "Immunization;Rotavirus Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BH02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines;Viral vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "RotaTeq is indicated for the active immunisation of infants from the age of six weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection. RotaTeq is to be used on the basis of official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "11/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/04/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/06/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "26/09/2017", "last_updated_date": "18/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rotateq" }, { "category": "Human", "name_of_medicine": "Orgalutran", "ema_product_number": "EMEA/H/C/000274", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000318971", "international_non_proprietary_name_common_name": "ganirelix", "active_substance": "ganirelix", "therapeutic_area_mesh": "Reproductive Techniques, Assisted;Ovulation Induction;Infertility, Female", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01CC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "The prevention of premature luteinising-hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques. In clinical studies, Orgalutran was used with recombinant human follicle-stimulating hormone or corifollitropin alfa, the sustained follicle stimulant.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/05/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/05/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "11/04/2017", "last_updated_date": "18/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orgalutran" }, { "category": "Human", "name_of_medicine": "Absimky", "ema_product_number": "EMEA/H/C/006585", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000272447", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Crohn Disease;Colitis, Ulcerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Plaque psoriasis ABSIMKY is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A). Paediatric plaque psoriasis ABSIMKY is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) ABSIMKY, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate. Crohn’s Disease Absimky is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Ulcerative colitis Absimky is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "20/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/12/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/12/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "18/10/2024", "last_updated_date": "18/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/absimky" }, { "category": "Human", "name_of_medicine": "Cosentyx", "ema_product_number": "EMEA/H/C/003729", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000304436", "international_non_proprietary_name_common_name": "secukinumab", "active_substance": "secukinumab", "therapeutic_area_mesh": "Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Plaque psoriasis Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. Hidradenitis suppurativa (HS) Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy. Psoriatic arthritis Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate. Axial spondyloarthritis (axSpA) Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-axSpA) Cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (NSAIDs). Juvenile idiopathic arthritis (JIA) Enthesitis-related arthritis (ERA) Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. Juvenile psoriatic arthritis (JPsA) Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "16/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/01/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "43", "first_published_date": "07/06/2018", "last_updated_date": "18/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cosentyx" }, { "category": "Human", "name_of_medicine": "Leflunomide ratiopharm", "ema_product_number": "EMEA/H/C/002035", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000317185", "international_non_proprietary_name_common_name": "leflunomide", "active_substance": "leflunomide", "therapeutic_area_mesh": "Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AK01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ratiopharm GmbH", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/11/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "21/12/2017", "last_updated_date": "18/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/leflunomide-ratiopharm" }, { "category": "Human", "name_of_medicine": "Mepact", "ema_product_number": "EMEA/H/C/000802", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319446", "international_non_proprietary_name_common_name": "mifamurtide", "active_substance": "mifamurtide", "therapeutic_area_mesh": "Osteosarcoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AX15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with postoperative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients two to 30 years of age at initial diagnosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Esteve Pharmaceuticals, S.A.", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/03/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "14/12/2016", "last_updated_date": "18/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mepact" }, { "category": "Human", "name_of_medicine": "Azacitidine Kabi", "ema_product_number": "EMEA/H/C/006154", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315328", "international_non_proprietary_name_common_name": "azacitidine", "active_substance": "azacitidine", "therapeutic_area_mesh": "Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Azacitidine Kabi is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation(HSCT) with: Intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the international prognostic scoring system (IPSS), Chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, Acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification, AML with > 30% marrow blasts according to the WHO classification.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "18/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/01/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "10/11/2023", "last_updated_date": "18/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/azacitidine-kabi" }, { "category": "Human", "name_of_medicine": "Breyanzi", "ema_product_number": "EMEA/H/C/004731", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000265024", "international_non_proprietary_name_common_name": "lisocabtagene maraleucel", "active_substance": "lisocabtagene maraleucel", "therapeutic_area_mesh": "Lymphoma, Large B-Cell, Diffuse;Lymphoma, Follicular;Mediastinal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XL08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.   Breyanzi is indicated for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy.  Breyanzi is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.   Breyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "21/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/01/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/04/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "24/01/2022", "last_updated_date": "18/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/breyanzi" }, { "category": "Human", "name_of_medicine": "Invokana", "ema_product_number": "EMEA/H/C/002649", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0069", "international_non_proprietary_name_common_name": "canagliflozin", "active_substance": "canagliflozin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BK02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Invokana is indicated for the treatment of adults and children aged 10 years and older with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:  as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "22/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "26/07/2018", "last_updated_date": "18/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/invokana" }, { "category": "Human", "name_of_medicine": "Ziihera", "ema_product_number": "EMEA/H/C/006380", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314733", "international_non_proprietary_name_common_name": "zanidatamab", "active_substance": "zanidatamab", "therapeutic_area_mesh": "Biliary Tract Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Jazz Pharmaceuticals Ireland Limited", "european_commission_decision_date": "17/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/04/2025", "last_updated_date": "17/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ziihera" }, { "category": "Human", "name_of_medicine": "Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)", "ema_product_number": "EMEA/H/C/001206", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0091/G", "international_non_proprietary_name_common_name": "pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)", "active_substance": "split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "12/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "14/12/2015", "last_updated_date": "17/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adjupanrix" }, { "category": "Human", "name_of_medicine": "Rapiscan", "ema_product_number": "EMEA/H/C/001176", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000291216", "international_non_proprietary_name_common_name": "regadenoson", "active_substance": "regadenoson", "therapeutic_area_mesh": "Myocardial Perfusion Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01EB21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GE Healthcare AS ", "european_commission_decision_date": "03/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/09/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "07/12/2017", "last_updated_date": "17/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rapiscan" }, { "category": "Human", "name_of_medicine": "Rivaroxaban Koanaa", "ema_product_number": "EMEA/H/C/006643", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rivaroxaban", "active_substance": "rivaroxaban", "therapeutic_area_mesh": "Venous Thromboembolism;Pulmonary Embolism;Venous Thrombosis;Stroke;Embolism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AF01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or kneereplacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Koanaa Healthcare GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/09/2025", "last_updated_date": "17/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rivaroxaban-koanaa" }, { "category": "Human", "name_of_medicine": "Ngenla", "ema_product_number": "EMEA/H/C/005633", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315819", "international_non_proprietary_name_common_name": "somatrogon", "active_substance": "somatrogon", "therapeutic_area_mesh": "Growth and Development", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01AC08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "16/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "14/12/2021", "last_updated_date": "16/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ngenla" }, { "category": "Human", "name_of_medicine": "Matever", "ema_product_number": "EMEA/H/C/002024", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000319484", "international_non_proprietary_name_common_name": "levetiracetam", "active_substance": "levetiracetam", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Matever is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Matever is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharmathen S.A.", "european_commission_decision_date": "16/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/10/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "02/07/2018", "last_updated_date": "16/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/matever" }, { "category": "Human", "name_of_medicine": "Seffalair Spiromax", "ema_product_number": "EMEA/H/C/004881", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000280812", "international_non_proprietary_name_common_name": "salmeterol;fluticasone propionate", "active_substance": "fluticasone propionate;salmeterol xinafoate", "therapeutic_area_mesh": "Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Seffalair Spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting ?? agonists.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "12/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "13/04/2021", "last_updated_date": "16/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/seffalair-spiromax" }, { "category": "Human", "name_of_medicine": "Omforro", "ema_product_number": "EMEA/H/C/005657", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "midazolam", "active_substance": "Midazolam Hydrochloride", "therapeutic_area_mesh": "Conscious Sedation;Anesthesia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05CD08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Conscious sedation before and during diagnostic or therapeutic procedures with or without local anaesthesia and premedication before induction of anaesthesia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Regulatory Pharma Net S.r.l.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "12/09/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/09/2025", "last_updated_date": "16/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/omforro" }, { "category": "Human", "name_of_medicine": "Erelzi", "ema_product_number": "EMEA/H/C/004192", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000312589", "international_non_proprietary_name_common_name": "etanercept", "active_substance": "etanercept", "therapeutic_area_mesh": "Arthritis, Psoriatic;Psoriasis;Arthritis, Juvenile Rheumatoid;Arthritis, Rheumatoid;Spondylitis, Ankylosing", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease?modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X?ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis?related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Etanercept has not been studied in children aged less than 2 years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease?modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X?ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis (AS) Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non?radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C?reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non?steroidal anti?inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet?A light (PUVA). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "16/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/04/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/06/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "28/03/2018", "last_updated_date": "16/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/erelzi" }, { "category": "Human", "name_of_medicine": "Ventavis", "ema_product_number": "EMEA/H/C/000474", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0074", "international_non_proprietary_name_common_name": "iloprost", "active_substance": "iloprost", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with primary pulmonary hypertension, classified as New York Heart Association functional class III, to improve exercise capacity and symptoms.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "30/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/11/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "09/02/2018", "last_updated_date": "16/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ventavis" }, { "category": "Human", "name_of_medicine": "Cyanokit", "ema_product_number": "EMEA/H/C/000806", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314820", "international_non_proprietary_name_common_name": "hydroxocobalamin", "active_substance": "hydroxocobalamin", "therapeutic_area_mesh": "Poisoning", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AB33", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of known or suspected cyanide poisoning. Cyanokit is to be administered together with appropriate decontamination and supportive measures.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SERB SA", "european_commission_decision_date": "16/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/11/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "20/07/2017", "last_updated_date": "16/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cyanokit" }, { "category": "Human", "name_of_medicine": "Cholib", "ema_product_number": "EMEA/H/C/002559", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000317729", "international_non_proprietary_name_common_name": "fenofibrate;simvastatin", "active_substance": "fenofibrate;simvastatin", "therapeutic_area_mesh": "Dyslipidemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL C levels when LDL C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Healthcare Limited", "european_commission_decision_date": "15/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "20/08/2018", "last_updated_date": "16/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cholib" }, { "category": "Human", "name_of_medicine": "Libmeldy", "ema_product_number": "EMEA/H/C/005321", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000317597", "international_non_proprietary_name_common_name": "autologous CD34+ cells encoding ARSA gene", "active_substance": "atidarsagene autotemcel", "therapeutic_area_mesh": "Leukodystrophy, Metachromatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Libmeldy is indicated for the treatment of metachromatic leukodystrophy (MLD) characterized by biallelic mutations in the arysulfatase A (ARSA) gene leading to a reduction of the ARSA enzymatic activity: in children with late infantile or early juvenile forms, without clinical manifestations of the disease, in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Orchard Therapeutics (Netherlands) B.V.", "european_commission_decision_date": "15/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/10/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/12/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "22/12/2020", "last_updated_date": "16/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/libmeldy" }, { "category": "Human", "name_of_medicine": "Coagadex", "ema_product_number": "EMEA/H/C/003855", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000302442", "international_non_proprietary_name_common_name": "human coagulation factor X", "active_substance": "human coagulation factor X", "therapeutic_area_mesh": "Factor X Deficiency", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vitamin K and other hemostatics;Antihemorrhagics;coagulation factor X", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency. Coagadex is indicated in all age groups.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Kedrion S.p.A.", "european_commission_decision_date": "21/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/03/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "16/03/2016", "last_updated_date": "15/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/coagadex" }, { "category": "Human", "name_of_medicine": "Remicade", "ema_product_number": "EMEA/H/C/000240", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000294601", "international_non_proprietary_name_common_name": "infliximab", "active_substance": "infliximab", "therapeutic_area_mesh": "Spondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Crohn Disease;Arthritis, Psoriatic;Colitis, Ulcerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated. Adult Crohn's disease Remicade is indicated for: treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies; treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric Crohn's disease Remicade is indicated for treatment of severe, active Crohn's disease, in children and adolescents aged six to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Remicade has been studied only in combination with conventional immunosuppressive therapy. Ulcerative colitis Remicade is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Remicade is indicated for treatment of severely active ulcerative colitis, in paediatric patients aged six to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Ankylosing spondylitis Remicade is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy. Psoriatic arthritis Remicade is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Remicade should be administered: in combination with methotrexate; or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Remicade has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Psoriasis Remicade is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultraviolet A (PUVA).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen Cilag International NV", "european_commission_decision_date": "26/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/08/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "69", "first_published_date": "26/04/2018", "last_updated_date": "15/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/remicade" }, { "category": "Human", "name_of_medicine": "Repatha", "ema_product_number": "EMEA/H/C/003766", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316562", "international_non_proprietary_name_common_name": "evolocumab", "active_substance": "Evolocumab", "therapeutic_area_mesh": "Dyslipidemias;Hypercholesterolemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hypercholesterolaemia and mixed dyslipidaemia Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Homozygous familial hypercholesterolaemia Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. Established atherosclerotic cardiovascular disease Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "12/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/07/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "04/06/2018", "last_updated_date": "15/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/repatha" }, { "category": "Human", "name_of_medicine": "Levetiracetam Hospira", "ema_product_number": "EMEA/H/C/002783", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315806", "international_non_proprietary_name_common_name": "levetiracetam", "active_substance": "levetiracetam", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam Hospira is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "12/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/10/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/01/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "01/11/2017", "last_updated_date": "15/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-hospira" }, { "category": "Human", "name_of_medicine": "Clopidogrel Viatris (previously Clopidogrel Taw Pharma)", "ema_product_number": "EMEA/H/C/001189", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000316467", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel besilate", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. In patients with moderate to high-risk Transient Ischaemic Attack (TIA) or minor Ischaemic Stroke (IS) Clopidogrel in combination with ASA is indicated in: Adult patients with moderate to high-risk TIA (ABCD2 score ?4) or minor IS (NIHSS ?3) within 24 hours of either the TIA or IS event. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation: In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "12/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "23/04/2018", "last_updated_date": "12/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-viatris" }, { "category": "Human", "name_of_medicine": "Synagis", "ema_product_number": "EMEA/H/C/000257", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0132", "international_non_proprietary_name_common_name": "palivizumab", "active_substance": "palivizumab", "therapeutic_area_mesh": "Respiratory Syncytial Virus Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Synagis is indicated for the prevention of serious lower-respiratory-tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease: children born at 35 weeks of gestation or less and less than six months of age at the onset of the RSV season; children less than two years of age and requiring treatment for bronchopulmonary dysplasia within the last six months; children less than two years of age and with haemodynamically significant congenital heart disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "14/09/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/08/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "46", "first_published_date": "08/05/2018", "last_updated_date": "12/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/synagis" }, { "category": "Human", "name_of_medicine": "Azacitidine Mylan", "ema_product_number": "EMEA/H/C/004984", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000317191", "international_non_proprietary_name_common_name": "azacitidine", "active_substance": "azacitidine", "therapeutic_area_mesh": "Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Azacitidine Mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 29% marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 30% blasts and multi lineage dysplasia, according to World Health Organisation (WHO) classification, AML with > 30% marrow blasts according to the WHO classification.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "12/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/03/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "06/04/2020", "last_updated_date": "12/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/azacitidine-mylan" }, { "category": "Human", "name_of_medicine": "Imaavy", "ema_product_number": "EMEA/H/C/006379", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "nipocalimab", "active_substance": "nipocalimab", "therapeutic_area_mesh": "Myasthenia Gravis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AL03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imaavy is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult and adolescent patients aged 12 years of age and older who are anti‑acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen Cilag International NV", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "03/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/09/2025", "last_updated_date": "12/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imaavy" }, { "category": "Human", "name_of_medicine": "Prevymis", "ema_product_number": "EMEA/H/C/004536", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000304418", "international_non_proprietary_name_common_name": "letermovir", "active_substance": "Letermovir", "therapeutic_area_mesh": "Cytomegalovirus Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 5 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).Prevymis is indicated for prophylaxis of CMV disease in CMV-seronegative adult and paediatric patients weighing at least 40 kg who have received a kidney transplant from a CMV-seropositive donor [D+/R-].Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 15 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). Consideration should be given to official guidance on the appropriate use of antiviral agents. ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "05/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/10/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "23/07/2018", "last_updated_date": "12/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prevymis" }, { "category": "Human", "name_of_medicine": "Afstyla", "ema_product_number": "EMEA/H/C/004075", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0057", "international_non_proprietary_name_common_name": "lonoctocog alfa", "active_substance": "lonoctocog alfa", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Afstyla can be used for all age groups.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CSL Behring GmbH", "european_commission_decision_date": "17/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/01/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "22/02/2018", "last_updated_date": "11/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/afstyla" }, { "category": "Human", "name_of_medicine": "Pifeltro", "ema_product_number": "EMEA/H/C/004747", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000268084", "international_non_proprietary_name_common_name": "doravirine", "active_substance": "doravirine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AG06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "16/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "21/09/2018", "last_updated_date": "11/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pifeltro" }, { "category": "Human", "name_of_medicine": "Hyrimoz", "ema_product_number": "EMEA/H/C/004320", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308055", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, Ankylosing;Uveitis;Hidradenitis Suppurativa;Colitis, Ulcerative;Arthritis, Juvenile Rheumatoid;Crohn Disease;Skin Diseases, Papulosquamous", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Hyrimoz in combination with methotrexate, is indicated for: \t\t\t- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. \t\t\t- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. \t\t\tHyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. \t\t\tAdalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis - Polyarticular juvenile idiopathic arthritis \t\t\tHyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Adalimumab has not been studied in patients aged less than 2 years. \t\t\t- Enthesitis-related arthritis \t\t\tHyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Axial spondyloarthritis - Ankylosing spondylitis (AS) \t\t\tHyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. \t\t\t- Axial spondyloarthritis without radiographic evidence of AS \t\t\tHyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Hyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. \t\t\tAdalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Hyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Hyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Hyrimoz is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Hyrimoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies. \t\t\t  Paediatric ulcerative colitis Hyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Ulcerative colitis Hyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Hyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Hyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "13/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "26/07/2018", "last_updated_date": "11/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz" }, { "category": "Human", "name_of_medicine": "Aimovig", "ema_product_number": "EMEA/H/C/004447", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000309660", "international_non_proprietary_name_common_name": "erenumab", "active_substance": "erenumab", "therapeutic_area_mesh": "Migraine Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02CD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month when initiating treatment with Aimovig.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "01/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "01/06/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "26/07/2018", "last_updated_date": "10/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aimovig" }, { "category": "Human", "name_of_medicine": "Livogiva", "ema_product_number": "EMEA/H/C/005087", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0015", "international_non_proprietary_name_common_name": "teriparatide", "active_substance": "teriparatide", "therapeutic_area_mesh": "Osteoporosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Livogiva is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Theramex Ireland Limited", "european_commission_decision_date": "14/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/08/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "06/01/2021", "last_updated_date": "10/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/livogiva" }, { "category": "Human", "name_of_medicine": "Kovaltry", "ema_product_number": "EMEA/H/C/003825", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000287726", "international_non_proprietary_name_common_name": "octocog alfa", "active_substance": "octocog alfa", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry can be used for all age groups.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "13/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/12/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/02/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "10/11/2017", "last_updated_date": "10/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kovaltry" }, { "category": "Human", "name_of_medicine": "Eydenzelt", "ema_product_number": "EMEA/H/C/005899", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000281997", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications;Retinal Vein Occlusion;Choroidal Neovascularization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eydenzelt is indicated for adults for the treatment of: neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual impairment due to diabetic macular oedema (DME) (see section 5.1), visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "23/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "27/03/2025", "last_updated_date": "10/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eydenzelt" }, { "category": "Veterinary", "name_of_medicine": "Sirolimus TriviumVet", "ema_product_number": "EMEA/V/C/006230", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "sirolimus", "active_substance": "sirolimus", "therapeutic_area_mesh": "", "species_veterinary": "Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "TriviumVet DAC", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "18/03/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/12/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/sirolimus-triviumvet" }, { "category": "Human", "name_of_medicine": "Rizmoic", "ema_product_number": "EMEA/H/C/004256", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000315032", "international_non_proprietary_name_common_name": "naldemedine", "active_substance": "naldemedine tosilate", "therapeutic_area_mesh": "Constipation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A06AH05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for constipation;Peripheral opioid receptor antagonists", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Shionogi B.V.", "european_commission_decision_date": "10/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/12/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/02/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "01/03/2019", "last_updated_date": "10/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rizmoic" }, { "category": "Human", "name_of_medicine": "Carbaglu", "ema_product_number": "EMEA/H/C/000461", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000291322", "international_non_proprietary_name_common_name": "carglumic acid", "active_substance": "carglumic acid", "therapeutic_area_mesh": "Amino Acid Metabolism, Inborn Errors;Propionic Acidemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Carbaglu is indicated in treatment of: hyperammonaemia due to N-acetylglutamate-synthase primary deficiency; hyperammonaemia due to isovaleric acidaemia; hyperammonaemia due to methymalonic acidaemia; hyperammonaemia due to propionic acidaemia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Tour Hekla", "european_commission_decision_date": "25/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/01/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "04/07/2018", "last_updated_date": "09/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/carbaglu" }, { "category": "Human", "name_of_medicine": "Inbrija", "ema_product_number": "EMEA/H/C/004786", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000303317", "international_non_proprietary_name_common_name": "levodopa", "active_substance": "levodopa", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merz Therapeutics GmbH", "european_commission_decision_date": "21/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "30/09/2019", "last_updated_date": "09/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/inbrija" }, { "category": "Human", "name_of_medicine": "Anzupgo", "ema_product_number": "EMEA/H/C/006109", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000264200", "international_non_proprietary_name_common_name": "delgocitinib", "active_substance": "Delgocitinib", "therapeutic_area_mesh": "Dermatitis;Eczema", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D11AH11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other dermatological preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Anzupgo is indicated for the treatment of moderate to severe chronic hand eczema (CHE)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "LEO Pharma A/S", "european_commission_decision_date": "23/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "26/07/2024", "last_updated_date": "09/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/anzupgo" }, { "category": "Human", "name_of_medicine": "Kimmtrak", "ema_product_number": "EMEA/H/C/004929", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000313831", "international_non_proprietary_name_common_name": "tebentafusp", "active_substance": "tebentafusp", "therapeutic_area_mesh": "Uveal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX75", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Immunocore Ireland Limited", "european_commission_decision_date": "08/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/01/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/04/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "22/04/2022", "last_updated_date": "09/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kimmtrak" }, { "category": "Human", "name_of_medicine": "Levetiracetam Accord", "ema_product_number": "EMEA/H/C/002290", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000316836", "international_non_proprietary_name_common_name": "levetiracetam", "active_substance": "levetiracetam", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "09/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/10/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "29/06/2018", "last_updated_date": "09/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-accord" }, { "category": "Human", "name_of_medicine": "Dacogen", "ema_product_number": "EMEA/H/C/002221", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0050", "international_non_proprietary_name_common_name": "decitabine", "active_substance": "decitabine", "therapeutic_area_mesh": "Leukemia, Myeloid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.  ", "european_commission_decision_date": "01/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "24/08/2017", "last_updated_date": "09/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dacogen" }, { "category": "Human", "name_of_medicine": "Aubagio", "ema_product_number": "EMEA/H/C/002514", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000292811", "international_non_proprietary_name_common_name": "teriflunomide", "active_substance": "teriflunomide", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AK02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Selective immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "06/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "28/05/2018", "last_updated_date": "09/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aubagio" }, { "category": "Human", "name_of_medicine": "Eviplera", "ema_product_number": "EMEA/H/C/002312", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000287296", "international_non_proprietary_name_common_name": "emtricitabine;rilpivirine;tenofovir disoproxil", "active_substance": "emtricitabine;rilpivirine hydrochloride;tenofovir disoproxil fumarate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ? 100,000 HIV-1 RNA copies/mL. As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of Eviplera.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences International Ltd ", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/11/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "19/07/2018", "last_updated_date": "09/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eviplera" }, { "category": "Human", "name_of_medicine": "Abecma", "ema_product_number": "EMEA/H/C/004662", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000293201", "international_non_proprietary_name_common_name": "idecabtagene vicleucel", "active_substance": "idecabtagene vicleucel", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti CD38 antibody and have demonstrated disease progression on the last therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "13/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/06/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "25/08/2021", "last_updated_date": "09/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abecma" }, { "category": "Human", "name_of_medicine": "Neulasta", "ema_product_number": "EMEA/H/C/000420", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG1743", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "Cancer;Neutropenia;Febrile Neutropenia;Chemotherapy-Induced Febrile Neutropenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "28/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2002", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "41", "first_published_date": "04/06/2018", "last_updated_date": "08/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta" }, { "category": "Human", "name_of_medicine": "Symkevi", "ema_product_number": "EMEA/H/C/004682", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000269024", "international_non_proprietary_name_common_name": "tezacaftor;ivacaftor", "active_substance": "tezacaftor;ivacaftor", "therapeutic_area_mesh": "Cystic Fibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R07AX31", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other respiratory system products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A?G, S945L, S977F, R1070W, D1152H, 2789+5G?A, 3272 26A?G, and 3849+10kbC?T.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vertex Pharmaceuticals (Ireland) Limited", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/10/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "22/11/2018", "last_updated_date": "08/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/symkevi" }, { "category": "Human", "name_of_medicine": "Xermelo", "ema_product_number": "EMEA/H/C/003937", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314461", "international_non_proprietary_name_common_name": "telotristat ethyl", "active_substance": "telotristat etiprate", "therapeutic_area_mesh": "Carcinoid Tumor;Neuroendocrine Tumors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16A", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SERB SAS", "european_commission_decision_date": "05/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/07/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "19/04/2018", "last_updated_date": "08/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xermelo" }, { "category": "Human", "name_of_medicine": "Filspari", "ema_product_number": "EMEA/H/C/005783", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000287206 and EMA/VR/0000280770", "international_non_proprietary_name_common_name": "sparsentan", "active_substance": "sparsentan", "therapeutic_area_mesh": "Glomerulonephritis, IGA", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09XX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Filspari is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion > 1.0 g/day (or urine protein-to-creatinine ratio > 0.75 g/g, see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vifor France", "european_commission_decision_date": "13/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "23/02/2024", "last_updated_date": "08/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/filspari" }, { "category": "Human", "name_of_medicine": "Lyfnua", "ema_product_number": "EMEA/H/C/005476", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000315549", "international_non_proprietary_name_common_name": "gefapixant", "active_substance": "gefapixant", "therapeutic_area_mesh": "Cough", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R05DB29", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cough and cold preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lyfnua is indicated in adults for the treatment of refractory or unexplained chronic cough.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "05/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "17/07/2023", "last_updated_date": "08/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lyfnua" }, { "category": "Human", "name_of_medicine": "Eucreas", "ema_product_number": "EMEA/H/C/000807", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000307544", "international_non_proprietary_name_common_name": "vildagliptin;metformin", "active_substance": "vildagliptin;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Combinations of oral blood glucose lowering drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eucreas is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "04/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "23/04/2018", "last_updated_date": "08/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eucreas" }, { "category": "Human", "name_of_medicine": "Ravicti", "ema_product_number": "EMEA/H/C/003822", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000315867", "international_non_proprietary_name_common_name": "glycerol phenylbutyrate", "active_substance": "glycerol phenylbutyrate", "therapeutic_area_mesh": "Urea Cycle Disorders, Inborn", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ravicti is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate-synthase-I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Immedica Pharma AB", "european_commission_decision_date": "05/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "23/05/2018", "last_updated_date": "05/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ravicti" }, { "category": "Human", "name_of_medicine": "Adynovi", "ema_product_number": "EMEA/H/C/004195", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0035", "international_non_proprietary_name_common_name": "rurioctocog alfa pegol", "active_substance": "rurioctocog alfa pegol", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Baxalta Innovations GmbH", "european_commission_decision_date": "13/07/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "12/03/2018", "last_updated_date": "05/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adynovi" }, { "category": "Human", "name_of_medicine": "Icandra (previously Vildagliptin / metformin hydrochloride Novartis)", "ema_product_number": "EMEA/H/C/001050", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000307544", "international_non_proprietary_name_common_name": "vildagliptin;metformin", "active_substance": "vildagliptin;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Combinations of oral blood glucose lowering drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "04/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/11/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "12/04/2018", "last_updated_date": "05/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/icandra" }, { "category": "Human", "name_of_medicine": "Zomarist", "ema_product_number": "EMEA/H/C/001049", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000307544", "international_non_proprietary_name_common_name": "vildagliptin;metformin", "active_substance": "vildagliptin;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zomarist is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "04/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/11/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "21/04/2017", "last_updated_date": "05/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zomarist" }, { "category": "Veterinary", "name_of_medicine": "Firocoxib CP-Pharma", "ema_product_number": "EMEA/V/C/006921", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "firocoxib", "active_substance": "firocoxib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products, non-steroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "05/12/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/firocoxib-cp-pharma" }, { "category": "Human", "name_of_medicine": "Jivi", "ema_product_number": "EMEA/H/C/004054", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000286640", "international_non_proprietary_name_common_name": "damoctocog alfa pegol", "active_substance": "Damoctocog alfa pegol", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in previously treated patients (PTPs) ≥ 7 years of age with haemophilia A (congenital factor VIII deficiency).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "12/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "28/01/2019", "last_updated_date": "04/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jivi" }, { "category": "Human", "name_of_medicine": "Sogroya", "ema_product_number": "EMEA/H/C/005030", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000278080", "international_non_proprietary_name_common_name": "somapacitan", "active_substance": "somapacitan", "therapeutic_area_mesh": "Growth", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01AC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sogroya is indicated for the replacement of endogenous growth hormone (GH) in children  aged 3  years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric GHD), and in adults with growth hormone deficiency (adult GHD).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "21/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "15/04/2021", "last_updated_date": "04/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sogroya" }, { "category": "Human", "name_of_medicine": "Dengvaxia", "ema_product_number": "EMEA/H/C/004171", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0033", "international_non_proprietary_name_common_name": "dengue tetravalent vaccine (live, attenuated)", "active_substance": "chimeric yellow fever dengue virus serotype 1 (live, attenuated);chimeric yellow fever dengue virus serotype 2 (live, attenuated);chimeric yellow fever dengue virus serotype 3 (live, attenuated);chimeric yellow fever dengue virus serotype 4 (live, attenuated)", "therapeutic_area_mesh": "Dengue", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 to 45 years of age with test-confirmed previous dengue infection (see sections 4.2, 4.4 and 4.8). The use of Dengvaxia should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "12/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/12/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "21/10/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "18/12/2018", "last_updated_date": "04/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dengvaxia" }, { "category": "Human", "name_of_medicine": "Brinsupri", "ema_product_number": "EMEA/H/C/005820", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Brensocatib", "active_substance": "Brensocatib monohydrate", "therapeutic_area_mesh": "Bronchiectasis;Lung Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Insmed Netherlands B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/10/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/10/2025", "last_updated_date": "04/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/brinsupri" }, { "category": "Human", "name_of_medicine": "Tuzodi", "ema_product_number": "EMEA/H/C/005658", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "midazolam", "active_substance": "Midazolam Hydrochloride", "therapeutic_area_mesh": "Seizures", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05CD08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of prolonged, acute, convulsive seizures in adults, adolescents, children and toddlers (from 2 years of age).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Regulatory Pharma Net S.r.l.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "12/09/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/09/2025", "last_updated_date": "04/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tuzodi" }, { "category": "Human", "name_of_medicine": "Hetlioz", "ema_product_number": "EMEA/H/C/003870", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0032/G", "international_non_proprietary_name_common_name": "tasimelteon", "active_substance": "tasimelteon", "therapeutic_area_mesh": "Sleep Disorders, Circadian Rhythm", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05CH", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vanda Pharmaceuticals Netherlands B.V.", "european_commission_decision_date": "10/10/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/07/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "06/07/2017", "last_updated_date": "04/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hetlioz" }, { "category": "Human", "name_of_medicine": "Sunitinib Accord", "ema_product_number": "EMEA/H/C/005419", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000269316", "international_non_proprietary_name_common_name": "sunitinib", "active_substance": "sunitinib", "therapeutic_area_mesh": "Gastrointestinal Stromal Tumors;Carcinoma, Renal Cell;Neuroendocrine Tumors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Gastrointestinal stromal tumour (GIST) Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "26/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "06/04/2021", "last_updated_date": "04/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sunitinib-accord" }, { "category": "Human", "name_of_medicine": "Tryngolza", "ema_product_number": "EMEA/H/C/006477", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314777", "international_non_proprietary_name_common_name": "olezarsen", "active_substance": "olezarsen sodium", "therapeutic_area_mesh": "Hyperlipoproteinemia Type I", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tryngolza is indicated as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS). ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Swedish Orphan Biovitrum AB (publ)", "european_commission_decision_date": "01/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/07/2025", "last_updated_date": "03/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tryngolza" }, { "category": "Human", "name_of_medicine": "Baraclude", "ema_product_number": "EMEA/H/C/000623", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000313870", "international_non_proprietary_name_common_name": "entecavir", "active_substance": "Entecavir", "therapeutic_area_mesh": "Hepatitis B, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis; decompensated liver disease. For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "03/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/06/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "26/06/2018", "last_updated_date": "03/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/baraclude" }, { "category": "Human", "name_of_medicine": "Delstrigo", "ema_product_number": "EMEA/H/C/004746", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000267948", "international_non_proprietary_name_common_name": "doravirine;lamivudine;tenofovir disoproxil", "active_substance": "doravirine;lamivudine;tenofovir disoproxil fumarate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for treatment of HIV infections, combinations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Delstrigo is indicated for the treatment of adults infected with HIV 1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir. Delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "16/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "21/09/2018", "last_updated_date": "03/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/delstrigo" }, { "category": "Human", "name_of_medicine": "Incellipan", "ema_product_number": "EMEA/H/C/006051", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249734", "international_non_proprietary_name_common_name": "pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)", "active_substance": "Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Incellipan is indicated for active immunisation against influenza in an officially declared pandemic. Incellipan should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Seqirus Netherlands B.V.", "european_commission_decision_date": "19/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "23/02/2024", "last_updated_date": "03/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/incellipan" }, { "category": "Human", "name_of_medicine": "NexoBrid", "ema_product_number": "EMEA/H/C/002246", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308735", "international_non_proprietary_name_common_name": "concentrate of proteolytic enzymes enriched in bromelain", "active_substance": "proteolytic enzymes enriched in bromelain", "therapeutic_area_mesh": "Debridement", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D03BA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Preparations for treatment of wounds and ulcers", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "NexoBrid is indicated in all age groups for removal of eschar in patients with deep partial- and full-thickness thermal burns.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "MediWound Germany GmbH", "european_commission_decision_date": "03/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/12/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "09/08/2018", "last_updated_date": "03/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nexobrid" }, { "category": "Human", "name_of_medicine": "Enhertu", "ema_product_number": "EMEA/H/C/005124", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000282648", "international_non_proprietary_name_common_name": "trastuzumab deruxtecan", "active_substance": "trastuzumab deruxtecan", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancerHER2-positive breast cancerEnhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.HER2-low and HER2-ultralow breast cancerEnhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic  hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment (see sections 4.2 and 5.1). HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4.2). Non-small cell lung cancer (NSCLC)Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.Gastric cancer Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Daiichi Sankyo Europe GmbH", "european_commission_decision_date": "21/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/01/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "08/02/2021", "last_updated_date": "03/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enhertu" }, { "category": "Human", "name_of_medicine": "Protopic", "ema_product_number": "EMEA/H/C/000374", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000314599", "international_non_proprietary_name_common_name": "tacrolimus", "active_substance": "tacrolimus", "therapeutic_area_mesh": "Dermatitis, Atopic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D11AH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other dermatological preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Flare treatment Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Children (two years of age and above) Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. Maintenance treatment Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "LEO Pharma A/S", "european_commission_decision_date": "02/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/02/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "30/06/2018", "last_updated_date": "03/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/protopic" }, { "category": "Human", "name_of_medicine": "Oczyesa", "ema_product_number": "EMEA/H/C/006322", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000313339", "international_non_proprietary_name_common_name": "octreotide", "active_substance": "octreotide hydrochloride", "therapeutic_area_mesh": "Acromegaly", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01CB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Oczyesa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Camurus AB", "european_commission_decision_date": "02/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/04/2025", "last_updated_date": "03/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/oczyesa" }, { "category": "Human", "name_of_medicine": "Ontozry", "ema_product_number": "EMEA/H/C/005377", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000273504", "international_non_proprietary_name_common_name": "cenobamate", "active_substance": "cenobamate", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Angelini Pharma S.p.A", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "13/04/2021", "last_updated_date": "03/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ontozry" }, { "category": "Human", "name_of_medicine": "Kaletra", "ema_product_number": "EMEA/H/C/000368", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000278292", "international_non_proprietary_name_common_name": "lopinavir;ritonavir", "active_substance": "lopinavir;ritonavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use;Protease inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children aged from 14 days and older. The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "30/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/03/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "65", "first_published_date": "23/05/2018", "last_updated_date": "02/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kaletra" }, { "category": "Human", "name_of_medicine": "Pregabalin Sandoz", "ema_product_number": "EMEA/H/C/004010", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000313464", "international_non_proprietary_name_common_name": "pregabalin", "active_substance": "pregabalin", "therapeutic_area_mesh": "Anxiety Disorders;Neuralgia;Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02BF02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other analgesics and antipyretics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Neuropathic pain Pregabalin Sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Sandoz is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "02/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/06/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "05/02/2018", "last_updated_date": "02/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pregabalin-sandoz" }, { "category": "Human", "name_of_medicine": "Izamby", "ema_product_number": "EMEA/H/C/006152", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000307311", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Izamby significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mabxience Research SL", "european_commission_decision_date": "20/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "25/04/2025", "last_updated_date": "02/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/izamby" }, { "category": "Human", "name_of_medicine": "Krazati", "ema_product_number": "EMEA/H/C/006013", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0010/G", "international_non_proprietary_name_common_name": "adagrasib", "active_substance": "adagrasib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX77", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Krazati as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/01/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "10/11/2023", "last_updated_date": "02/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/krazati" }, { "category": "Human", "name_of_medicine": "Upstaza", "ema_product_number": "EMEA/H/C/005352", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000312499", "international_non_proprietary_name_common_name": "eladocagene exuparvovec", "active_substance": "Eladocagene exuparvovec", "therapeutic_area_mesh": "Amino Acid Metabolism, Inborn Errors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB26", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products;Enzymes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic L amino acid decarboxylase (AADC) deficiency with a severe phenotype (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "PTC Therapeutics International Limited", "european_commission_decision_date": "02/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/07/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "20/05/2022", "last_updated_date": "02/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/upstaza" }, { "category": "Human", "name_of_medicine": "Rasagiline Viatris (previously Rasagiline Mylan)", "ema_product_number": "EMEA/H/C/004064", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000314043", "international_non_proprietary_name_common_name": "rasagiline", "active_substance": "rasagiline tartrate", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rasagiline Viatris is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "26/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/04/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "18/05/2016", "last_updated_date": "01/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rasagiline-viatris" }, { "category": "Human", "name_of_medicine": "Benepali", "ema_product_number": "EMEA/H/C/004007", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000304814", "international_non_proprietary_name_common_name": "etanercept", "active_substance": "etanercept", "therapeutic_area_mesh": "Arthritis, Psoriatic;Arthritis, Rheumatoid;Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Benepali in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Benepali, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Etanercept has not been studied in children aged less than 2 years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "01/12/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/01/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "06/02/2018", "last_updated_date": "01/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/benepali" }, { "category": "Human", "name_of_medicine": "Xelevia", "ema_product_number": "EMEA/H/C/000762", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000314048", "international_non_proprietary_name_common_name": "sitagliptin", "active_substance": "sitagliptin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For adult patients with type-2 diabetes mellitus, Xelevia is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Xelevia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "24/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "42", "first_published_date": "20/08/2018", "last_updated_date": "01/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xelevia" }, { "category": "Human", "name_of_medicine": "Cerezyme", "ema_product_number": "EMEA/H/C/000157", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0136", "international_non_proprietary_name_common_name": "imiglucerase", "active_substance": "imiglucerase", "therapeutic_area_mesh": "Gaucher Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cerezyme (imiglucerase) is indicated for use as longterm enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant nonneurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions: anaemia after exclusion of other causes, such as iron deficiency Thrombocytopenia Bone disease after exclusion of other causes such as Vitamin D deficiency hepatomegaly or splenomegaly", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi B.V.", "european_commission_decision_date": "16/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/1997", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "10/08/2017", "last_updated_date": "01/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cerezyme" }, { "category": "Human", "name_of_medicine": "Velmetia", "ema_product_number": "EMEA/H/C/000862", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000314050", "international_non_proprietary_name_common_name": "sitagliptin;metformin", "active_substance": "sitagliptin;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For patients with type-2 diabetes mellitus: Velmetia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Velmetia is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Velmetia is indicated as triple combination therapy with a PPAR agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Velmetia is also indicated as add on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "26/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/04/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/07/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "40", "first_published_date": "29/06/2018", "last_updated_date": "01/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/velmetia" }, { "category": "Human", "name_of_medicine": "Zinplava", "ema_product_number": "EMEA/H/C/004136", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000314567", "international_non_proprietary_name_common_name": "bezlotoxumab", "active_substance": "Bezlotoxumab", "therapeutic_area_mesh": "Enterocolitis, Pseudomembranous", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BB21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/01/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "15/06/2018", "last_updated_date": "01/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zinplava" }, { "category": "Human", "name_of_medicine": "Efficib", "ema_product_number": "EMEA/H/C/000896", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000314786", "international_non_proprietary_name_common_name": "sitagliptin;metformin", "active_substance": "sitagliptin;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For patients with type-2 diabetes mellitus: Efficib is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Efficib is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Efficib is indicated as triple combination therapy with a PPAR agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Efficib is also indicated as add on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp and Dohme B.V", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/04/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/07/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "22/05/2018", "last_updated_date": "01/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/efficib" }, { "category": "Human", "name_of_medicine": "Tesavel", "ema_product_number": "EMEA/H/C/000910", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000314584", "international_non_proprietary_name_common_name": "sitagliptin", "active_substance": "sitagliptin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For patients with type-2 diabetes mellitus, Tesavel is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a PPAR? agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control; a peroxisome-proliferator-activated-receptor-gamma (PPAR?) agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. Tesavel is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "28/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/11/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/01/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "08/08/2018", "last_updated_date": "01/12/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tesavel" }, { "category": "Human", "name_of_medicine": "Kyprolis", "ema_product_number": "EMEA/H/C/003790", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0058", "international_non_proprietary_name_common_name": "carfilzomib", "active_substance": "carfilzomib", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX45", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "14/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "04/06/2018", "last_updated_date": "28/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kyprolis" }, { "category": "Veterinary", "name_of_medicine": "Hemosyvet", "ema_product_number": "EMEA/V/C/006461", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "etamsylate", "active_substance": "Etamsylate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "blood and blood forming organs;antihemorrhagics;vitamin K and other hemostatics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/07/2025", "last_updated_date": "28/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/hemosyvet" }, { "category": "Human", "name_of_medicine": "Atropine sulfate FGK", "ema_product_number": "EMEA/H/C/006385", "medicine_status": "Refused", "opinion_status": "Negative", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "atropine", "active_substance": "atropine sulfate", "therapeutic_area_mesh": "Myopia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01FA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals;Mydriatics and cycloplegics;Anticholinergics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Atropine sulfate FGK 0.1 mg/ml is indicated to slow myopia progression in children aged 6 to 10 years with spherical equivalent refraction (SER) in the range of -0.50 to ‑6.00 diopter (D).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "FGK Representative Service GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "21/11/2025", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/05/2025", "last_updated_date": "28/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/atropine-sulfate-fgk" }, { "category": "Human", "name_of_medicine": "Byfavo", "ema_product_number": "EMEA/H/C/005246", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000278275", "international_non_proprietary_name_common_name": "remimazolam", "active_substance": "remimazolam besilate", "therapeutic_area_mesh": "Conscious Sedation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05CD14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Remimazolam is indicated in adults for procedural sedation. Remimazolam 50 mg is indicated in adults for intravenous induction and maintenance of general anaesthesia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Paion Pharma GmbH", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "20/04/2021", "last_updated_date": "28/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/byfavo" }, { "category": "Human", "name_of_medicine": "Talvey", "ema_product_number": "EMEA/H/C/005864", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000280497", "international_non_proprietary_name_common_name": "talquetamab", "active_substance": "talquetamab", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX29", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti CD38 antibody and have demonstrated disease progression on the last therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.", "european_commission_decision_date": "16/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/08/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "17/07/2023", "last_updated_date": "28/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/talvey" }, { "category": "Human", "name_of_medicine": "Memantine Mylan", "ema_product_number": "EMEA/H/C/002660", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296010", "international_non_proprietary_name_common_name": "memantine", "active_substance": "memantine hydrochloride", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics;Other anti-dementia drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with moderate to severe Alzheimer’s disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/04/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "08/01/2018", "last_updated_date": "28/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/memantine-mylan" }, { "category": "Human", "name_of_medicine": "Fingolimod Mylan", "ema_product_number": "EMEA/H/C/005661", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000303376", "international_non_proprietary_name_common_name": "fingolimod", "active_substance": "Fingolimod", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "06/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "31/08/2021", "last_updated_date": "28/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fingolimod-mylan" }, { "category": "Human", "name_of_medicine": "Rinvoq", "ema_product_number": "EMEA/H/C/004760", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308226", "international_non_proprietary_name_common_name": "upadacitinib", "active_substance": "upadacitinib", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Psoriatic;Axial Spondyloarthritis;Spondylitis, Ankylosing;Giant Cell Arteritis;Dermatitis, Atopic;Colitis, Ulcerative;Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA44", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Rinvoq may be used as monotherapy or in combination with methotrexate. Psoriatic arthritis Rinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Rinvoq may be used as monotherapy or in combination with methotrexate. Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA)  Rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)  Rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Giant cell arteritis Rinvoq is indicated for the treatment of giant cell arteritis in adult patients. Atopic dermatitis Rinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Ulcerative colitis Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.  Crohn’s disease Rinvoq is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/12/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "18/10/2019", "last_updated_date": "28/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rinvoq" }, { "category": "Human", "name_of_medicine": "Rolcya", "ema_product_number": "EMEA/H/C/006507", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000293149", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Osteoporosis;Osteoporosis, Postmenopausal;Bone Resorption", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/07/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "23/05/2025", "last_updated_date": "27/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rolcya" }, { "category": "Human", "name_of_medicine": "Jubbonti", "ema_product_number": "EMEA/H/C/005964", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000293149", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Osteoporosis;Osteoporosis, Postmenopausal;Bone Resorption", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/05/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "22/03/2024", "last_updated_date": "27/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jubbonti" }, { "category": "Veterinary", "name_of_medicine": "Librela", "ema_product_number": "EMEA/V/C/005180", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bedinvetmab", "active_substance": "bedinvetmab", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Nervous system;Other analgesics and antipyretics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/09/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/05/2021", "last_updated_date": "27/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/librela" }, { "category": "Veterinary", "name_of_medicine": "Lenivia", "ema_product_number": "EMEA/V/C/006455", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "izenivetmab", "active_substance": "izenivetmab", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Nervous system;Other analgesics and antipyretics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/10/2025", "last_updated_date": "27/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/lenivia" }, { "category": "Human", "name_of_medicine": "Metalyse", "ema_product_number": "EMEA/H/C/000306", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0075/G", "international_non_proprietary_name_common_name": "tenecteplase", "active_substance": "tenecteplase", "therapeutic_area_mesh": "Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AD11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Metalyse is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left-bundle-branch block within six hours after the onset of acute-myocardial-infarction symptoms. Metalyse is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "19/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/02/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "25/07/2018", "last_updated_date": "27/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/metalyse" }, { "category": "Human", "name_of_medicine": "Lynkuet", "ema_product_number": "EMEA/H/C/006298", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "elinzanetant", "active_substance": "elinzanetant", "therapeutic_area_mesh": "Hot Flashes;Menopause;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other gynecologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of moderate to severe vasomotor symptoms (VMS).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/09/2025", "last_updated_date": "27/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lynkuet" }, { "category": "Human", "name_of_medicine": "Rubraca", "ema_product_number": "EMEA/H/C/004272", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000313308", "international_non_proprietary_name_common_name": "rucaparib", "active_substance": "rucaparib camsylate", "therapeutic_area_mesh": "Ovarian Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "pharmaand GmbH", "european_commission_decision_date": "27/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "06/11/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/05/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "24/05/2018", "last_updated_date": "27/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rubraca" }, { "category": "Human", "name_of_medicine": "Celdoxome pegylated liposomal", "ema_product_number": "EMEA/H/C/005330", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "H/C/005330/T/0004", "international_non_proprietary_name_common_name": "doxorubicin hydrochloride", "active_substance": "doxorubicin hydrochloride", "therapeutic_area_mesh": "Breast Neoplasms;Ovarian Neoplasms;Multiple Myeloma;Sarcoma, Kaposi", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01DB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Celdoxome pegylated liposomal is indicated in adults: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Baxter Holding B.V.", "european_commission_decision_date": "21/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/09/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "20/06/2022", "last_updated_date": "27/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/celdoxome-pegylated-liposomal" }, { "category": "Human", "name_of_medicine": "Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)", "ema_product_number": "EMEA/H/C/003918", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000312776", "international_non_proprietary_name_common_name": "dinutuximab beta", "active_substance": "Dinutuximab beta", "therapeutic_area_mesh": "Neuroblastoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin 2 (IL 2).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Netherlands B.V.", "european_commission_decision_date": "26/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/03/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/05/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "05/03/2018", "last_updated_date": "26/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qarziba" }, { "category": "Human", "name_of_medicine": "Zejula", "ema_product_number": "EMEA/H/C/004249", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000303299", "international_non_proprietary_name_common_name": "niraparib", "active_substance": "niraparib (tosilate monohydrate)", "therapeutic_area_mesh": "Fallopian Tube Neoplasms;Peritoneal Neoplasms;Ovarian Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XK02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zejula is indicated: as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "19/12/2017", "last_updated_date": "26/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zejula" }, { "category": "Human", "name_of_medicine": "Hydrocortisone Aguettant", "ema_product_number": "EMEA/H/C005201", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "hydrocortisone", "therapeutic_area_mesh": "Bronchopulmonary Dysplasia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoire Aguettant", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "18/09/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/10/2025", "last_updated_date": "25/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hydrocortisone-aguettant" }, { "category": "Human", "name_of_medicine": "Refixia", "ema_product_number": "EMEA/H/C/004178", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249232", "international_non_proprietary_name_common_name": "nonacog beta pegol", "active_substance": "nonacog beta pegol", "therapeutic_area_mesh": "Hemophilia B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). Refixia can be used for all age groups.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "04/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/03/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/06/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "02/06/2017", "last_updated_date": "25/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/refixia" }, { "category": "Veterinary", "name_of_medicine": "Vaxxitek HVT+IBD+H5", "ema_product_number": "EMEA/V/C/006751", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian influenza vaccine (live recombinant)", "active_substance": "Turkey herpesvirus, strain rHVT-IBD-H5 (cell-associated), expressing the VP2 protein gene of Infectious bursal disease virus and haemagglutinin gene of Avian influenza virus subtype H5, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Live viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/10/2025", "last_updated_date": "25/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vaxxitek-hvtibdh5" }, { "category": "Human", "name_of_medicine": "Tukysa", "ema_product_number": "EMEA/H/C/005263", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308552", "international_non_proprietary_name_common_name": "tucatinib", "active_substance": "tucatinib", "therapeutic_area_mesh": "Breast Neoplasms;Neoplasm Metastasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2?positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "24/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "18/02/2021", "last_updated_date": "25/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tukysa" }, { "category": "Human", "name_of_medicine": "Accofil", "ema_product_number": "EMEA/H/C/003956", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000263401", "international_non_proprietary_name_common_name": "filgrastim", "active_substance": "filgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Accofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Accofil are similar in adults and children receiving cytotoxic chemotherapy. Accofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ? 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Accofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "12/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "25/05/2018", "last_updated_date": "25/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/accofil" }, { "category": "Human", "name_of_medicine": "Zynlonta", "ema_product_number": "EMEA/H/C/005685", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000281443", "international_non_proprietary_name_common_name": "loncastuximab tesirine", "active_substance": "loncastuximab tesirine", "therapeutic_area_mesh": "Lymphoma, Large B-Cell, Diffuse;Lymphoma, B-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Swedish Orphan Biovitrum AB", "european_commission_decision_date": "24/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/12/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "14/09/2022", "last_updated_date": "25/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zynlonta" }, { "category": "Human", "name_of_medicine": "Pedea", "ema_product_number": "EMEA/H/C/000549", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000264965", "international_non_proprietary_name_common_name": "ibuprofen", "active_substance": "Ibuprofen", "therapeutic_area_mesh": "Ductus Arteriosus, Patent", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01EB16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Rare Diseases", "european_commission_decision_date": "21/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/07/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "14/02/2017", "last_updated_date": "25/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pedea" }, { "category": "Human", "name_of_medicine": "Brukinsa", "ema_product_number": "EMEA/H/C/004978", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282181", "international_non_proprietary_name_common_name": "zanubrutinib", "active_substance": "zanubrutinib", "therapeutic_area_mesh": "Waldenstrom Macroglobulinemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EL03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Brukinsa as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. Brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. Brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL). Brukinsa in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BeOne Medicines Ireland Limited", "european_commission_decision_date": "24/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/07/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "15/12/2021", "last_updated_date": "24/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/brukinsa" }, { "category": "Human", "name_of_medicine": "Sirturo", "ema_product_number": "EMEA/H/C/002614", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249065", "international_non_proprietary_name_common_name": "bedaquiline", "active_substance": "bedaquiline fumarate", "therapeutic_area_mesh": "Tuberculosis, Multidrug-Resistant", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J04AK05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for treatment of tuberculosis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": " Sirturo is indicated for use as part of an appropriate combination regimen in adult and paediatric patients (2 years to less than 18 years of age and weighing at least 7 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. Consideration should be given to official guidance on the appropriate use of antibacterial agents.  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.", "european_commission_decision_date": "22/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/03/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "05/03/2018", "last_updated_date": "24/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sirturo" }, { "category": "Human", "name_of_medicine": "Lupkynis", "ema_product_number": "EMEA/H/C/005256", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00011020/202501", "international_non_proprietary_name_common_name": "voclosporin", "active_substance": "voclosporin", "therapeutic_area_mesh": "Lupus Nephritis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AD03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Otsuka Pharmaceutical Netherlands B.V.", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "19/07/2022", "last_updated_date": "24/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lupkynis" }, { "category": "Human", "name_of_medicine": "Reblozyl", "ema_product_number": "EMEA/H/C/004444", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000267384", "international_non_proprietary_name_common_name": "luspatercept", "active_substance": "Luspatercept", "therapeutic_area_mesh": "Anemia;Myelodysplastic Syndromes;beta-Thalassemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia.  Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia. ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol Myers Squibb Pharma EEIG", "european_commission_decision_date": "18/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/04/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/06/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "08/07/2020", "last_updated_date": "24/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/reblozyl" }, { "category": "Human", "name_of_medicine": "Hizentra", "ema_product_number": "EMEA/H/C/002127", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000294311", "international_non_proprietary_name_common_name": "human normal immunoglobulin (SCIg)", "active_substance": "human normal immunoglobulin (SCIg)", "therapeutic_area_mesh": "Immunologic Deficiency Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Replacement therapy in adults, children and adolescents (0-18 years) in: - Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l. *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. Immunomodulatory therapy in adults, children and adolescents (0-18 years): - Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CSL Behring GmbH", "european_commission_decision_date": "25/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/02/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/04/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "05/03/2018", "last_updated_date": "24/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hizentra" }, { "category": "Human", "name_of_medicine": "Ebvallo", "ema_product_number": "EMEA/H/C/004577", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000306999", "international_non_proprietary_name_common_name": "tabelecleucel", "active_substance": "tabelecleucel", "therapeutic_area_mesh": "Lymphoproliferative Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Pierre Fabre Medicament", "european_commission_decision_date": "18/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/12/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "12/10/2022", "last_updated_date": "24/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ebvallo" }, { "category": "Human", "name_of_medicine": "Steglujan", "ema_product_number": "EMEA/H/C/004313", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000313044", "international_non_proprietary_name_common_name": "ertugliflozin;sitagliptin", "active_substance": "ertugliflozin l-pyroglutamic acid;sitagliptin phosphate monohydrate", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD24", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Combinations of oral blood glucose lowering drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control. in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "21/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/03/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "23/08/2018", "last_updated_date": "21/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/steglujan" }, { "category": "Human", "name_of_medicine": "Segluromet", "ema_product_number": "EMEA/H/C/004314", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000312917", "international_non_proprietary_name_common_name": "ertugliflozin;metformin hydrochloride", "active_substance": "ertugliflozin l-pyroglutamic acid;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD23", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Combinations of oral blood glucose lowering drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: in patients not adequately controlled on their maximally tolerated dose of metformin alone in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes in patients already being treated with the combination of ertugliflozin and metformin as separate tablets.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "21/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/01/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/03/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "26/04/2018", "last_updated_date": "21/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/segluromet" }, { "category": "Human", "name_of_medicine": "Invanz", "ema_product_number": "EMEA/H/C/000389", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000312910", "international_non_proprietary_name_common_name": "ertapenem", "active_substance": "ertapenem sodium", "therapeutic_area_mesh": "Community-Acquired Infections;Streptococcal Infections;Staphylococcal Infections;Gram-Negative Bacterial Infections;Surgical Wound Infection;Pneumonia, Bacterial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01DH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment Treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required: intra-abdominal infections; community-acquired pneumonia; acute gynaecological infections; diabetic foot infections of the skin and soft tissue. Prevention Invanz is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "21/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/04/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "08/05/2018", "last_updated_date": "21/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/invanz" }, { "category": "Human", "name_of_medicine": "Obizur", "ema_product_number": "EMEA/H/C/002792", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000248614", "international_non_proprietary_name_common_name": "susoctocog alfa", "active_substance": "susoctocog alfa", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to Factor VIII. Obizur is indicated in adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Baxalta Innovations GmbH", "european_commission_decision_date": "14/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "01/06/2017", "last_updated_date": "21/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/obizur" }, { "category": "Human", "name_of_medicine": "Yervoy", "ema_product_number": "EMEA/H/C/002213", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000285155", "international_non_proprietary_name_common_name": "ipilimumab", "active_substance": "Ipilimumab", "therapeutic_area_mesh": "Melanoma;Carcinoma, Renal Cell;Carcinoma, Non-Small-Cell Lung;Mesothelioma, Malignant;Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "MelanomaYervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4).  Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Renal cell carcinoma (RCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Non-small cell lung cancer (NSCLC) Yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Malignant pleural mesothelioma (MPM) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) Yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability high colorectal cancer in the following settings:- first-line treatment of unresectable or metastatic colorectal cancer;- treatment of metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.Hepatocellular carcinoma (HCC)Yervoy in combination with nivolumab is indicated for the first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "13/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/07/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "59", "first_published_date": "14/06/2018", "last_updated_date": "21/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yervoy" }, { "category": "Human", "name_of_medicine": "Pyzchiva", "ema_product_number": "EMEA/H/C/006183", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000301212", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Crohn Disease;Colitis, Ulcerative;Arthritis, Psoriatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Crohn’s DiseasePyzchiva is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.Plaque psoriasisPyzchiva is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).Paediatric plaque psoriasisPyzchiva is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1). Psoriatic arthritis (PsA)Pyzchiva, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).Crohn’s DiseasePyzchiva is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "03/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "23/02/2024", "last_updated_date": "21/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pyzchiva" }, { "category": "Human", "name_of_medicine": "Eiyzey", "ema_product_number": "EMEA/H/C/006745", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications;Retinal Vein Occlusion;Choroidal Neovascularization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eiyzey is indicated for adults for the treatment of- neovascular (wet) age-related macular degeneration (AMD) (see section 5.1),- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),- visual impairment due to diabetic macular oedema (DME) (see section 5.1),- visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1)s.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/06/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/06/2025", "last_updated_date": "21/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eiyzey" }, { "category": "Human", "name_of_medicine": "Yselty", "ema_product_number": "EMEA/H/C/005442", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0013", "international_non_proprietary_name_common_name": "linzagolix choline", "active_substance": "linzagolix choline", "therapeutic_area_mesh": "Leiomyoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01CC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Yselty is indicated in adult women of reproductive age for: -           treatment of moderate to severe symptoms of uterine fibroids,-           symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Theramex Ireland Limited", "european_commission_decision_date": "22/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/06/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "14/12/2021", "last_updated_date": "21/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yselty" }, { "category": "Human", "name_of_medicine": "Afinitor", "ema_product_number": "EMEA/H/C/001038", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310437", "international_non_proprietary_name_common_name": "everolimus", "active_substance": "everolimus", "therapeutic_area_mesh": "Carcinoma, Renal Cell;Breast Neoplasms;Pancreatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hormone-receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Afinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease. Renal-cell carcinoma Afinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "20/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/08/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "08/05/2018", "last_updated_date": "20/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/afinitor" }, { "category": "Human", "name_of_medicine": "Votubia", "ema_product_number": "EMEA/H/C/002311", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310311", "international_non_proprietary_name_common_name": "everolimus", "active_substance": "everolimus", "therapeutic_area_mesh": "Tuberous Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery. The evidence is based on analysis of change in sum of angiomyolipoma volume. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease?related symptoms, has not been demonstrated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "20/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/09/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "12/07/2018", "last_updated_date": "20/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/votubia" }, { "category": "Human", "name_of_medicine": "Maviret", "ema_product_number": "EMEA/H/C/004430", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0055", "international_non_proprietary_name_common_name": "glecaprevir;pibrentasvir", "active_substance": "glecaprevir;pibrentasvir", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AP57", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older. Maviret coated granules is indicated for the treatment of chronic hepatitis C virus (HCV) infection in children 3 years and older.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "02/03/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/06/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "15/06/2018", "last_updated_date": "20/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/maviret" }, { "category": "Human", "name_of_medicine": "Xydalba", "ema_product_number": "EMEA/H/C/002840", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000313336", "international_non_proprietary_name_common_name": "dalbavancin", "active_substance": "dalbavancin hydrochloride", "therapeutic_area_mesh": "Soft Tissue Infections;Skin Diseases, Bacterial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01XA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients from birth (see sections 4.4 and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "20/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/12/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/02/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "17/03/2017", "last_updated_date": "20/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xydalba" }, { "category": "Human", "name_of_medicine": "Atectura Breezhaler", "ema_product_number": "EMEA/H/C/005067", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000312770", "international_non_proprietary_name_common_name": "indacaterol;mometasone", "active_substance": "indacaterol acetate;mometasone furoate", "therapeutic_area_mesh": "Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Atectura Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "20/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/05/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "23/06/2020", "last_updated_date": "20/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/atectura-breezhaler" }, { "category": "Human", "name_of_medicine": "Enerzair Breezhaler", "ema_product_number": "EMEA/H/C/005061", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000312489", "international_non_proprietary_name_common_name": "indacaterol;glycopyrronium bromide;mometasone", "active_substance": "indacaterol;glycopyrronium bromide;mometasone", "therapeutic_area_mesh": "Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Enerzair Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "20/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "07/09/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/07/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "21/07/2020", "last_updated_date": "20/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enerzair-breezhaler" }, { "category": "Human", "name_of_medicine": "Gobivaz", "ema_product_number": "EMEA/H/C/006560", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "golimumab", "active_substance": "golimumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Juvenile;Arthritis, Psoriatic;Axial Spondyloarthritis;Colitis, Ulcerative;Non-Radiographic Axial Spondyloarthritis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis (RA) Gobivaz, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Golimumab, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis (pJIA) Gobivaz in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX. Psoriatic arthritis (PsA) Gobivaz, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Golimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Axial spondyloarthritis Ankylosing spondylitis (AS) Gobivaz is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-Axial SpA) Gobivaz is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Ulcerative colitis (UC) Gobivaz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Advanz Pharma Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/09/2025", "last_updated_date": "20/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gobivaz" }, { "category": "Human", "name_of_medicine": "Dafiro", "ema_product_number": "EMEA/H/C/000776", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000309769", "international_non_proprietary_name_common_name": "amlodipine;valsartan", "active_substance": "amlodipine;valsartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. Dafiro is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "19/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "07/06/2018", "last_updated_date": "19/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dafiro" }, { "category": "Human", "name_of_medicine": "Copalia", "ema_product_number": "EMEA/H/C/000774", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000309769", "international_non_proprietary_name_common_name": "amlodipine;valsartan", "active_substance": "valsartan;amlodipine (as amlodipine besilate)", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. Copalia is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "19/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "04/06/2018", "last_updated_date": "19/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/copalia" }, { "category": "Human", "name_of_medicine": "Exforge", "ema_product_number": "EMEA/H/C/000716", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000309769", "international_non_proprietary_name_common_name": "amlodipine;valsartan", "active_substance": "valsartan;amlodipine (as amlodipine besilate)", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. Exforge is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "19/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "25/06/2018", "last_updated_date": "19/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exforge" }, { "category": "Human", "name_of_medicine": "Synjardy", "ema_product_number": "EMEA/H/C/003770", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000303989", "international_non_proprietary_name_common_name": "empagliflozin;metformin", "active_substance": "empagliflozin;metformin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD20", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Synjardy is indicated in adults and children aged 10 years and above for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:•          in patients insufficiently controlled on their maximally tolerated dose of metformin alone•          in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products•          in patients already being treated with the combination of empagliflozin and metformin as separate tablets.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the population studied, see sections 4.4, 4.5 and 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim", "european_commission_decision_date": "18/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/05/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "31/05/2018", "last_updated_date": "19/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/synjardy" }, { "category": "Human", "name_of_medicine": "Descovy", "ema_product_number": "EMEA/H/C/004094", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1588", "international_non_proprietary_name_common_name": "emtricitabine;tenofovir alafenamide", "active_substance": "emtricitabine;tenofovir alafenamide", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "16/02/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/02/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/04/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "28/05/2018", "last_updated_date": "19/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/descovy" }, { "category": "Human", "name_of_medicine": "Viread", "ema_product_number": "EMEA/H/C/000419", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/2892/202303", "international_non_proprietary_name_common_name": "tenofovir disoproxil", "active_substance": "tenofovir disoproxil fumarate", "therapeutic_area_mesh": "Hepatitis B, Chronic;HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "HIV 1 infection Viread 123 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg. The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Viread 123 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 17 kg to less than 22 kg, with compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1. HIV 1 infection Viread 163 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 22 kg to less than 28 kg. The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Viread 163 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 22 kg to less than 28 kg, with: compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1. HIV 1 infection Viread 204 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 28 kg to less than 35 kg. The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Viread 204 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 28 kg to less than 35 kg, with: compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis.  With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1. HIV 1 infection Viread 245 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults. In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml). Viread 245 mg film coated tablets are also indicated for the treatment of HIV 1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1). evidence of lamivudine resistant hepatitis B virus (see sections 4.8 and 5.1). decompensated liver disease (see sections 4.4, 4.8 and 5.1). Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with: compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1. HIV 1 infection Viread 33 mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate. Viread 33 mg/g granules are also indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults for whom a solid dosage form is not appropriate. In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml). The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Viread 33 mg/g granules are indicated for the treatment of chronic hepatitis B in adults for whom a solid dosage form is not appropriate with: compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1). evidence of lamivudine resistant hepatitis B virus (see sections 4.8 and 5.1). decompensated liver disease (see sections 4.4, 4.8 and 5.1). Viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis B in paediatric patients2 to < 18 years of age for whom a solid dosage form is not appropriate with: compensated liver disease and evidence of immune active disease, i.e. active viral replication, and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "16/02/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/03/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/02/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "61", "first_published_date": "19/07/2018", "last_updated_date": "18/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/viread" }, { "category": "Human", "name_of_medicine": "Hirobriz Breezhaler", "ema_product_number": "EMEA/H/C/001211", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308592", "international_non_proprietary_name_common_name": "indacaterol", "active_substance": "indacaterol maleate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AC18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "18/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/11/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "23/08/2018", "last_updated_date": "18/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hirobriz-breezhaler" }, { "category": "Human", "name_of_medicine": "Oslif Breezhaler", "ema_product_number": "EMEA/H/C/001210", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308592", "international_non_proprietary_name_common_name": "indacaterol", "active_substance": "indacaterol maleate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AC18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "18/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/11/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "08/05/2018", "last_updated_date": "18/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/oslif-breezhaler" }, { "category": "Human", "name_of_medicine": "Onbrez Breezhaler", "ema_product_number": "EMEA/H/C/001114", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308592", "international_non_proprietary_name_common_name": "indacaterol", "active_substance": "indacaterol maleate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AC18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "18/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/11/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "23/08/2018", "last_updated_date": "18/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/onbrez-breezhaler" }, { "category": "Human", "name_of_medicine": "Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan", "ema_product_number": "EMEA/H/C/004240", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000312907", "international_non_proprietary_name_common_name": "efavirenz;emtricitabine;tenofovir disoproxil", "active_substance": "efavirenz;emtricitabine;tenofovir disoproxil maleate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan prior to initiation of their first antiretroviral treatment regimen. The demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients. No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "18/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/06/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/09/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "15/08/2018", "last_updated_date": "18/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/efavirenz-emtricitabine-tenofovir-disoproxil-mylan" }, { "category": "Human", "name_of_medicine": "Prevenar 20 (previously Apexxnar)", "ema_product_number": "EMEA/H/C/005451", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000291245", "international_non_proprietary_name_common_name": "pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)", "active_substance": "Pneumococcal polysaccharide serotype 1;Pneumococcal polysaccharide serotype 3;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 5;Pneumococcal polysaccharide serotype 6A;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 7F;Pneumococcal polysaccharide serotype 8;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 10A;Pneumococcal polysaccharide serotype 11A;pneumococcal polysaccharide serotype 12F;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 15b;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19A;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 22F;Pneumococcal polysaccharide serotype 23F;Pneumococcal polysaccharide serotype 33F", "therapeutic_area_mesh": "Pneumococcal Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AL02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. Apexxnar should be used in accordance with official recommendations.    ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "23/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "14/12/2021", "last_updated_date": "18/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prevenar-20" }, { "category": "Human", "name_of_medicine": "Truvada", "ema_product_number": "EMEA/H/C/000594", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/1210/202304", "international_non_proprietary_name_common_name": "emtricitabine;tenofovir disoproxil", "active_substance": "emtricitabine;tenofovir disoproxil fumarate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of HIV-1 infection: Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Truvada is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. Pre-exposure prophylaxis (PrEP): Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "16/02/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/11/2004", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/02/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "49", "first_published_date": "19/07/2017", "last_updated_date": "18/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/truvada" }, { "category": "Human", "name_of_medicine": "Voxzogo", "ema_product_number": "EMEA/H/C/005475", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000300615", "international_non_proprietary_name_common_name": "vosoritide", "active_substance": "vosoritide", "therapeutic_area_mesh": "Achondroplasia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioMarin International Limited", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/06/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "23/06/2021", "last_updated_date": "18/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/voxzogo" }, { "category": "Human", "name_of_medicine": "Ozawade", "ema_product_number": "EMEA/H/C/005117", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II-0012", "international_non_proprietary_name_common_name": "pitolisant", "active_substance": "pitolisant", "therapeutic_area_mesh": "Sleep Apnea, Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bioprojet Pharma", "european_commission_decision_date": "16/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/09/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "20/05/2021", "last_updated_date": "18/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ozawade" }, { "category": "Human", "name_of_medicine": "Ristfor", "ema_product_number": "EMEA/H/C/001235", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000309751", "international_non_proprietary_name_common_name": "sitagliptin;metformin hydrochloride", "active_substance": "sitagliptin;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For patients with type-2 diabetes mellitus: Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Ristfor is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated-receptor-gamma (PPAR?) agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR? agonist. Ristfor is also indicated as add-on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "10/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/12/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/03/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "29/06/2018", "last_updated_date": "17/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ristfor" }, { "category": "Human", "name_of_medicine": "Awiqli", "ema_product_number": "EMEA/H/C/005978", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000268356", "international_non_proprietary_name_common_name": "insulin icodec", "active_substance": "insulin icodec", "therapeutic_area_mesh": "Diabetes Mellitus;Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Insulins and analogues for injection, long-acting", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus in adults", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "02/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/05/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "22/03/2024", "last_updated_date": "17/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/awiqli" }, { "category": "Human", "name_of_medicine": "Isentress", "ema_product_number": "EMEA/H/C/000860", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000309676", "international_non_proprietary_name_common_name": "raltegravir", "active_substance": "raltegravir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AJ01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "12/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/11/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/12/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "45", "first_published_date": "07/06/2018", "last_updated_date": "17/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/isentress" }, { "category": "Human", "name_of_medicine": "Ivabradine Anpharm", "ema_product_number": "EMEA/H/C/004187", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000286236", "international_non_proprietary_name_common_name": "ivabradine", "active_substance": "ivabradine", "therapeutic_area_mesh": "Angina Pectoris;Heart Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01EB17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other cardiac preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated: in adults unable to tolerate or with a contra-indication to the use of beta-blockers or in combination with beta-blockers in patients inadequately controlled with an optimal betablocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "\"Anpharm\" Przedsiębiorstwo Farmaceutyczne S.A.", "european_commission_decision_date": "17/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/09/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "11/01/2018", "last_updated_date": "17/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ivabradine-anpharm" }, { "category": "Human", "name_of_medicine": "Corlentor", "ema_product_number": "EMEA/H/C/000598", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000286236", "international_non_proprietary_name_common_name": "ivabradine", "active_substance": "ivabradine hydrochloride", "therapeutic_area_mesh": "Angina Pectoris;Heart Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01EB17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated: in adults unable to tolerate or with a contraindication to the use of beta-blockers or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "13/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/10/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "11/01/2018", "last_updated_date": "17/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/corlentor" }, { "category": "Human", "name_of_medicine": "Procoralan", "ema_product_number": "EMEA/H/C/000597", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000286236", "international_non_proprietary_name_common_name": "ivabradine", "active_substance": "ivabradine hydrochloride", "therapeutic_area_mesh": "Angina Pectoris;Heart Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01EB17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated : in adults unable to tolerate or with a contraindication to the use of beta-blockers or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "13/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/10/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "11/01/2018", "last_updated_date": "17/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/procoralan" }, { "category": "Human", "name_of_medicine": "Imreplys", "ema_product_number": "EMEA/H/C/006411", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "sargramostim", "active_substance": "sargramostim", "therapeutic_area_mesh": "Acute Radiation Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imreplys is indicated for treatment of patients of all ages acutely exposed to myelosuppressive doses of radiation with Haematopoietic Sub-syndrome of Acute Radiation Syndrome (H-ARS). Imreplys should be used in accordance with official radiological/nuclear emergency recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Partner Therapeutics Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/06/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/06/2025", "last_updated_date": "17/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imreplys" }, { "category": "Human", "name_of_medicine": "Anagrelide Viatris (previously Anagrelide Mylan)", "ema_product_number": "EMEA/H/C/004585", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000309803", "international_non_proprietary_name_common_name": "anagrelide", "active_substance": "anagrelide hydrochloride", "therapeutic_area_mesh": "Thrombocythemia, Essential", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX35", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Anagrelide Viatris is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.An at-risk patient An at-risk essential thrombocythaemia patient is defined by one or more of the following features: >60 years of age or a platelet count >1,000 x 10⁹/l or a history of thrombo-haemorrhagic events.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "14/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/02/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "15/02/2018", "last_updated_date": "14/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/anagrelide-viatris" }, { "category": "Human", "name_of_medicine": "Ondexxya", "ema_product_number": "EMEA/H/C/004108", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000304332", "international_non_proprietary_name_common_name": "andexanet alfa", "active_substance": "andexanet alfa", "therapeutic_area_mesh": "Drug-Related Side Effects and Adverse Reactions", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "14/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/02/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/04/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "27/06/2019", "last_updated_date": "14/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ondexxya" }, { "category": "Human", "name_of_medicine": "Ranivisio", "ema_product_number": "EMEA/H/C/005019", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296796", "international_non_proprietary_name_common_name": "ranibizumab", "active_substance": "ranibizumab", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetic Retinopathy;Diabetes Complications", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ranivisio is indicated in adults for: • The treatment of neovascular (wet) age-related macular degeneration (AMD) • The treatment of visual impairment due to diabetic macular oedema (DME) • The treatment of proliferative diabetic retinopathy (PDR) • The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) • The treatment of visual impairment due to choroidal neovascularisation (CNV)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Midas Pharma GmbH", "european_commission_decision_date": "13/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/08/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "20/06/2022", "last_updated_date": "14/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ranivisio" }, { "category": "Human", "name_of_medicine": "Epruvy (previously Ranibizumab Midas)", "ema_product_number": "EMEA/H/C/006528", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296796", "international_non_proprietary_name_common_name": "ranibizumab", "active_substance": "ranibizumab", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Choroidal Neovascularization;Diabetes Complications", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularisation (CNV).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Midas Pharma GmbH", "european_commission_decision_date": "13/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "26/07/2024", "last_updated_date": "14/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/epruvy" }, { "category": "Human", "name_of_medicine": "Kizfizo", "ema_product_number": "EMEA/H/C/006169", "medicine_status": "Refused", "opinion_status": "Negative", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "temozolomide", "active_substance": "temozolomide", "therapeutic_area_mesh": "Neuroblastoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neuroblastoma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ORPHELIA Pharma", "european_commission_decision_date": "02/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/02/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "02/05/2025", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/11/2024", "last_updated_date": "14/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kizfizo" }, { "category": "Human", "name_of_medicine": "Ohtuvayre", "ema_product_number": "EMEA/H/C/006742", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ensifentrine", "active_substance": "ensifentrine", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03BX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Maintenance treatment in symptomatic adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Verona Pharma Ireland Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "30/10/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/11/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ohtuvayre" }, { "category": "Human", "name_of_medicine": "Insulin Aspart Injection", "ema_product_number": "EMEA/H/C/006720", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "insulin aspart", "active_substance": "insulin aspart", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Masuu Pharma Europe Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/10/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/11/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-aspart-injection" }, { "category": "Human", "name_of_medicine": "Enzalutamide Accordpharma", "ema_product_number": "EMEA/H/C/006612", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "enzalutamide", "active_substance": "enzalutamide", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of prostate cancer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare", "european_commission_decision_date": "09/01/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/11/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/11/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enzalutamide-accordpharma" }, { "category": "Human", "name_of_medicine": "Juluca", "ema_product_number": "EMEA/H/C/004427", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249653", "international_non_proprietary_name_common_name": "dolutegravir;rilpivirine", "active_substance": "dolutegravir sodium;rilpivirine hydrochloride", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare B.V.", "european_commission_decision_date": "16/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/03/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/05/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "16/05/2018", "last_updated_date": "14/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/juluca" }, { "category": "Human", "name_of_medicine": "Tivicay", "ema_product_number": "EMEA/H/C/002753", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249653", "international_non_proprietary_name_common_name": "dolutegravir", "active_substance": "dolutegravir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare BV", "european_commission_decision_date": "16/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/11/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "01/03/2018", "last_updated_date": "14/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tivicay" }, { "category": "Human", "name_of_medicine": "Zavicefta", "ema_product_number": "EMEA/H/C/004027", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000247225", "international_non_proprietary_name_common_name": "ceftazidime;avibactam", "active_substance": "avibactam sodium;ceftazidime pentahydrate", "therapeutic_area_mesh": "Pneumonia, Bacterial;Soft Tissue Infections;Pneumonia;Urinary Tract Infections;Gram-Negative Bacterial Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01DD52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections: Complicated intra-abdominal infection (cIAI) Complicated urinary tract infection (cUTI), including pyelonephritis Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Ireland Pharmaceuticals Unlimited Company", "european_commission_decision_date": "20/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/04/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/06/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "14/06/2018", "last_updated_date": "14/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zavicefta" }, { "category": "Human", "name_of_medicine": "Sitagliptin / Metformin hydrochloride Accord", "ema_product_number": "EMEA/H/C/005850", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000263349", "international_non_proprietary_name_common_name": "sitagliptin;metformin hydrochloride", "active_substance": "metformin hydrochloride;sitagliptin hydrochloride monohydrate", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For adult patients with type 2 diabetes mellitus: It is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. It is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. It is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR? agonist. It is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "19/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/07/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/07/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "03/08/2022", "last_updated_date": "13/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-metformin-hydrochloride-accord" }, { "category": "Human", "name_of_medicine": "Efient", "ema_product_number": "EMEA/H/C/000984", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000268753", "international_non_proprietary_name_common_name": "prasugrel", "active_substance": "prasugrel", "therapeutic_area_mesh": "Acute Coronary Syndrome;Angina, Unstable;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST-segment-elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Substipharm", "european_commission_decision_date": "22/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/12/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/02/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "16/03/2017", "last_updated_date": "13/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/efient" }, { "category": "Human", "name_of_medicine": "Janumet", "ema_product_number": "EMEA/H/C/000861", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000309673", "international_non_proprietary_name_common_name": "sitagliptin;metformin", "active_substance": "sitagliptin;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For patients with type 2 diabetes mellitus: Janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Janumet is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Janumet is indicated as triple combination therapy with a PPAR  agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR  agonist. Janumet is also indicated as add on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "10/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/04/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/07/2008", "refusal_of_marketing_authorisation_date": "18/02/2009", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "29/06/2018", "last_updated_date": "13/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/janumet" }, { "category": "Human", "name_of_medicine": "Lutathera", "ema_product_number": "EMEA/H/C/004123", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0058", "international_non_proprietary_name_common_name": "lutetium (177Lu) oxodotreotide", "active_substance": "lutetium (177Lu) oxodotreotide", "therapeutic_area_mesh": "Neuroendocrine Tumors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V10XX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other therapeutic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP?NETs) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Advanced Accelerator Applications", "european_commission_decision_date": "03/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/09/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "21/03/2018", "last_updated_date": "12/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lutathera" }, { "category": "Human", "name_of_medicine": "Eyluxvi", "ema_product_number": "EMEA/H/C/006282", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications;Retinal Vein Occlusion", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eyluxvi is indicated for adults for the treatment of- neovascular (wet) age-related macular degeneration (AMD) (see section 5.1),- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),- visual impairment due to diabetic macular oedema (DME) (see section 5.1),- visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1). ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biolitec pharma Limited Zweigniederlassung Jena", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/07/2025", "last_updated_date": "12/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eyluxvi" }, { "category": "Human", "name_of_medicine": "Glivec", "ema_product_number": "EMEA/H/C/000406", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000290092", "international_non_proprietary_name_common_name": "imatinib", "active_substance": "imatinib", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma;Gastrointestinal Stromal Tumors;Dermatofibrosarcoma;Myelodysplastic-Myeloproliferative Diseases;Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Hypereosinophilic Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Glivec is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia-chromosome (bcr-abl)-positive (Ph+) chronic myeloid leukaemia (CML) for whom bone-marrow transplantation is not considered as the first line of treatment; adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis; adult and paediatric patients with newly diagnosed Philadelphia-chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy; adult patients with relapsed or refractory Ph+ ALL as monotherapy; adult patients with myelodysplastic / myeloproliferative diseases (MDS / MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements; adult patients with advanced hypereosinophilic syndrome (HES) and / or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRa rearrangement. The effect of Glivec on the outcome of bone-marrow transplantation has not been determined. Glivec is indicated for: the treatment of adult patients with Kit (CD 117)-positive unresectable and / or metastatic malignant gastrointestinal stromal tumours (GIST); the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment; the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and / or metastatic DFSP who are not eligible for surgery. In adult and paediatric patients, the effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS / MPD, on haematological response rates in HES / CEL and on objective response rates in adult patients with unresectable and / or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with Glivec in patients with MDS / MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "16/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/07/2001", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/11/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "51", "first_published_date": "25/06/2018", "last_updated_date": "12/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/glivec" }, { "category": "Human", "name_of_medicine": "Datopotamab deruxtecan Daiichi Sankyo", "ema_product_number": "EMEA/H/C/006081", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "datopotamab deruxtecan", "active_substance": "datopotamab deruxtecan", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX35", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with locally advanced or metastatic non squamous non-small cell lung cancer (NSCLC)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Daiichi Sankyo Europe GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/12/2024", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/01/2025", "last_updated_date": "11/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/datopotamab-deruxtecan-daiichi-sankyo" }, { "category": "Human", "name_of_medicine": "Slenyto", "ema_product_number": "EMEA/H/C/004425", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000306421", "international_non_proprietary_name_common_name": "melatonin", "active_substance": "melatonin", "therapeutic_area_mesh": "Sleep Initiation and Maintenance Disorders;Autistic Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05CH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Slenyto is indicated for: treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient. treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "RAD Neurim Pharmaceuticals EEC SARL", "european_commission_decision_date": "07/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "10/10/2018", "last_updated_date": "11/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/slenyto" }, { "category": "Human", "name_of_medicine": "Jakavi", "ema_product_number": "EMEA/H/C/002464", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000310678", "international_non_proprietary_name_common_name": "ruxolitinib", "active_substance": "ruxolitinib phosphate", "therapeutic_area_mesh": "Myeloproliferative Disorders;Polycythemia Vera;Graft vs Host Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EJ01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.Polycythaemia vera (PV)Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.Graft versus host disease (GvHD)Acute GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).Chronic GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1). Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.Polycythaemia vera (PV)Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.Graft versus host disease (GvHD)Acute GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).Chronic GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "10/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/04/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "38", "first_published_date": "22/05/2018", "last_updated_date": "10/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jakavi" }, { "category": "Human", "name_of_medicine": "Tecovirimat SIGA", "ema_product_number": "EMEA/H/C/005248", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000244868", "international_non_proprietary_name_common_name": "tecovirimat monohydrate", "active_substance": "tecovirimat", "therapeutic_area_mesh": "Poxviridae Infections;Cowpox;Monkeypox;Vaccinia;Smallpox", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX24", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tecovirimat SIGA is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg: Smallpox Monkeypox Cowpox Tecovirimat SIGA is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4.4 and 5.1). Tecovirimat SIGA should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SIGA Technologies Netherlands B.V.", "european_commission_decision_date": "02/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/11/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/01/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "10/11/2021", "last_updated_date": "10/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tecovirimat-siga" }, { "category": "Human", "name_of_medicine": "Sitagliptin SUN", "ema_product_number": "EMEA/H/C/005741", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000290396", "international_non_proprietary_name_common_name": "sitagliptin fumarate", "active_substance": "sitagliptin fumarate", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For adult patients with type 2 diabetes mellitus, Sitagliptin SUN is indicated to improve glycaemic control: as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin SUN is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "22/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/10/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "12/10/2021", "last_updated_date": "10/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-sun" }, { "category": "Human", "name_of_medicine": "Flixabi", "ema_product_number": "EMEA/H/C/004020", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000268910", "international_non_proprietary_name_common_name": "infliximab", "active_substance": "infliximab", "therapeutic_area_mesh": "Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Arthritis, Rheumatoid;Crohn Disease;Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Flixabi, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate. dult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated (see section 5.1). Adult Crohn’s disease Flixabi is indicated for: reatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. reatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric Crohn’s disease Flixabi is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy. Ulcerative colitis Flixabi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Flixabi is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Ankylosing spondylitis Flixabiis indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy. Psoriatic arthritis Flixabi is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Flixabi should be administered: in combination with methotrexate or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1). Psoriasis Flixabi is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "19/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/03/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "06/08/2018", "last_updated_date": "10/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/flixabi" }, { "category": "Human", "name_of_medicine": "Dectova", "ema_product_number": "EMEA/H/C/004102", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308615", "international_non_proprietary_name_common_name": "zanamivir", "active_substance": "zanamivir", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ?6 months) when: The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or Other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient. Dectova should be used in accordance with official guidance.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "10/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/04/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "07/06/2019", "last_updated_date": "10/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dectova" }, { "category": "Human", "name_of_medicine": "HBVaxPro", "ema_product_number": "EMEA/H/C/000373", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000310649", "international_non_proprietary_name_common_name": "hepatitis B vaccine (recombinant DNA)", "active_substance": "hepatitis B, recombinant surface antigen", "therapeutic_area_mesh": "Hepatitis B;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "5 micrograms HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-B virus. The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection. 10 micrograms HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-B virus. The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection. 40 micrograms HBVaxPro is indicated for the active immunisation against hepatitis-B-virus infection caused by all known subtypes in predialysis and dialysis adult patients. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "07/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/04/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "18/12/2017", "last_updated_date": "07/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hbvaxpro" }, { "category": "Human", "name_of_medicine": "Baiama", "ema_product_number": "EMEA/H/C/005980", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000300507", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Retinal Vein Occlusion;Choroidal Neovascularization;Diabetes Complications", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineovascularisation agents;Ocular vascular disorder agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Baiama is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual impairment due to diabetic macular oedema (DME) (see section 5.1), visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Formycon AG", "european_commission_decision_date": "06/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/01/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "11/11/2024", "last_updated_date": "07/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/baiama" }, { "category": "Human", "name_of_medicine": "Ahzantive", "ema_product_number": "EMEA/H/C/006607", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000300507", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Retinal Vein Occlusion;Choroidal Neovascularization;Diabetes Complications", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ahzantive is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), • visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), • visual impairment due to diabetic macular oedema (DME) (see section 5.1), • visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Formycon AG", "european_commission_decision_date": "06/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/01/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "15/11/2024", "last_updated_date": "07/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ahzantive" }, { "category": "Human", "name_of_medicine": "Cubicin", "ema_product_number": "EMEA/H/C/000637", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000310384", "international_non_proprietary_name_common_name": "daptomycin", "active_substance": "daptomycin", "therapeutic_area_mesh": "Gram-Positive Bacterial Infections;Bacteremia;Soft Tissue Infections;Endocarditis, Bacterial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01XX09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cubicin is indicated for the treatment of the following infections. Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI. Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "07/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/11/2005", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/01/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "41", "first_published_date": "08/08/2018", "last_updated_date": "07/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cubicin" }, { "category": "Human", "name_of_medicine": "Zepatier", "ema_product_number": "EMEA/H/C/004126", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000310229", "international_non_proprietary_name_common_name": "elbasvir;grazoprevir", "active_substance": "elbasvir;grazoprevir", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AP54", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Direct acting antivirals;Antivirals for systemic use;Antivirals for treatment of HCV infections", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "07/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/05/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/07/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "15/06/2018", "last_updated_date": "07/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zepatier" }, { "category": "Human", "name_of_medicine": "Bridion", "ema_product_number": "EMEA/H/C/000885", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000309809", "international_non_proprietary_name_common_name": "sugammadex", "active_substance": "sugammadex", "therapeutic_area_mesh": "Neuromuscular Blockade", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AB35", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reversal of neuromuscular blockade induced by rocuronium or vecuronium. For the peadiatric population: sugammadex is only recommended for routine reversal of rocuronium-induced blockade in children and adolescents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "06/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/07/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "02/12/2016", "last_updated_date": "06/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bridion" }, { "category": "Human", "name_of_medicine": "Temodal", "ema_product_number": "EMEA/H/C/000229", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000309483", "international_non_proprietary_name_common_name": "temozolomide", "active_substance": "temozolomide", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Temodal hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "06/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/01/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "40", "first_published_date": "23/08/2018", "last_updated_date": "06/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/temodal" }, { "category": "Human", "name_of_medicine": "Quadramet", "ema_product_number": "EMEA/H/C/000150", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000246157", "international_non_proprietary_name_common_name": "samarium [153Sm] lexidronam pentasodium", "active_substance": "samarium (153Sm) lexidronam pentasodium", "therapeutic_area_mesh": "Pain;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V10BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Therapeutic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Quadramet is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium [99mTc]-labelled biphosphonates on bone scan. The presence of osteoblastic metastases which take up technetium [99mTc]-labelled biphosphonates should be confirmed prior to therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CIS bio international", "european_commission_decision_date": "04/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/02/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "04/05/2015", "last_updated_date": "06/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/quadramet" }, { "category": "Human", "name_of_medicine": "Duavive", "ema_product_number": "EMEA/H/C/002314", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000309416", "international_non_proprietary_name_common_name": "oestrogens conjugated;bazedoxifene", "active_substance": "oestrogens conjugated;bazedoxifene", "therapeutic_area_mesh": "Postmenopause", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03CC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "conjugated estrogens and bazedoxifene", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Duavive is indicated for: Treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate. The experience treating women older than 65 years is limited.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "06/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/10/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/12/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "02/08/2018", "last_updated_date": "06/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duavive" }, { "category": "Human", "name_of_medicine": "Kymriah", "ema_product_number": "EMEA/H/C/004090", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000309349", "international_non_proprietary_name_common_name": "tisagenlecleucel", "active_substance": "tisagenlecleucel", "therapeutic_area_mesh": "Precursor B-Cell Lymphoblastic Leukemia-Lymphoma;Lymphoma, Large B-Cell, Diffuse", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XL04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kymriah is indicated for the treatment of: • Paediatric and young adult patients up to and including 25 years of age with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse. • Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy. • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "06/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "23/08/2018", "last_updated_date": "06/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kymriah" }, { "category": "Human", "name_of_medicine": "Xoanacyl", "ema_product_number": "EMEA/H/C/006402", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ferric citrate coordination complex", "active_substance": "ferric citrate coordination complex", "therapeutic_area_mesh": "Iron Deficiencies;Renal Insufficiency, Chronic;Hyperphosphatemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AE08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xoanacyl is indicated for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Averoa", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/03/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/03/2025", "last_updated_date": "06/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xoanacyl" }, { "category": "Human", "name_of_medicine": "Pregabalin Viatris Pharma (previously Pregabalin Pfizer)", "ema_product_number": "EMEA/H/C/003880", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000290223", "international_non_proprietary_name_common_name": "pregabalin", "active_substance": "pregabalin", "therapeutic_area_mesh": "Anxiety Disorders;Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02BF02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other analgesics and antipyretics;Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Neuropathic painPregabalin Viatris Pharma is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Viatris Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Viatris Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Healthcare Limited", "european_commission_decision_date": "05/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/02/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/04/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "38", "first_published_date": "30/07/2018", "last_updated_date": "05/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pregabalin-viatris-pharma" }, { "category": "Human", "name_of_medicine": "Pegasys", "ema_product_number": "EMEA/H/C/000395", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000307242", "international_non_proprietary_name_common_name": "peginterferon alfa-2a", "active_substance": "peginterferon alfa-2a", "therapeutic_area_mesh": "Hepatitis C, Chronic;Hepatitis B, Chronic;Polycythemia Vera;Thrombocythemia, Essential", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Polycythaemia veraPegasys is indicated as monotherapy in adults for the treatment of polycythaemia vera. Essential thrombocythaemiaPegasys is indicated as monotherapy in adults for the treatment of essential thrombocythaemia..Chronic hepatitis BAdult patientsPegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (ALT) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1).Paediatric patients 3 years of age and olderPegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels. With respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1.Chronic hepatitis CAdult patientsPegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.2 and 5.1.Paediatric patients 5 years of age and olderPegasys in combination with ribavirin is indicated for the treatment of CHC in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA.When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "pharmaand GmbH", "european_commission_decision_date": "31/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2002", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "48", "first_published_date": "15/03/2018", "last_updated_date": "05/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pegasys" }, { "category": "Human", "name_of_medicine": "Beyonttra", "ema_product_number": "EMEA/H/C/006333", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000297381", "international_non_proprietary_name_common_name": "acoramidis", "active_substance": "acoramidis hydrochloride", "therapeutic_area_mesh": "Amyloid Neuropathies, Familial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01EB25", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG ", "european_commission_decision_date": "03/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "13/12/2024", "last_updated_date": "05/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/beyonttra" }, { "category": "Veterinary", "name_of_medicine": "Portela", "ema_product_number": "EMEA/V/C/005890", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "relfovetmab", "active_substance": "relfovetmab", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Nervous system;Other analgesics and antipyretics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/09/2025", "last_updated_date": "05/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/portela" }, { "category": "Human", "name_of_medicine": "Mektovi", "ema_product_number": "EMEA/H/C/004579", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000241083", "international_non_proprietary_name_common_name": "binimetinib", "active_substance": "binimetinib", "therapeutic_area_mesh": "Melanoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "MelanomaBinimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Non-small cell lung cancer (NSCLC)Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pierre Fabre Medicament", "european_commission_decision_date": "18/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "27/07/2018", "last_updated_date": "05/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mektovi" }, { "category": "Human", "name_of_medicine": "Braftovi", "ema_product_number": "EMEA/H/C/004580", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000241083", "international_non_proprietary_name_common_name": "encorafenib", "active_substance": "Encorafenib", "therapeutic_area_mesh": "Melanoma;Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "MelanomaEncorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Colorectal cancer (CRC)Encorafenib in combination with cetuximab is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC)  with a BRAF V600E mutation, who have received prior systemic therapy.Non-small cell lung cancer (NSCLC)Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pierre Fabre Medicament", "european_commission_decision_date": "18/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "27/07/2018", "last_updated_date": "05/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/braftovi" }, { "category": "Human", "name_of_medicine": "Ivemend", "ema_product_number": "EMEA/H/C/000743", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000307871", "international_non_proprietary_name_common_name": "fosaprepitant", "active_substance": "fosaprepitant", "therapeutic_area_mesh": "Vomiting;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A04AD12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiemetics and antinauseants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and paediatric patients aged 6 months and older. Ivemend 150 mg is given as part of a combination therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "03/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "23/07/2018", "last_updated_date": "05/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ivemend" }, { "category": "Human", "name_of_medicine": "Rekambys", "ema_product_number": "EMEA/H/C/005060", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000257069", "international_non_proprietary_name_common_name": "rilpivirine", "active_substance": "rilpivirine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AG05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "REKAMBYS is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "14/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/10/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/12/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "04/01/2021", "last_updated_date": "04/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rekambys" }, { "category": "Human", "name_of_medicine": "Piqray", "ema_product_number": "EMEA/H/C/004804", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000275207", "international_non_proprietary_name_common_name": "alpelisib", "active_substance": "alpelisib", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "02/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/05/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/07/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "30/07/2020", "last_updated_date": "04/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/piqray" }, { "category": "Human", "name_of_medicine": "Vgenfli", "ema_product_number": "EMEA/H/C/006192", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetes Complications;Retinal Vein Occlusion;Choroidal Neovascularization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vgenfli is indicated for adults for the treatment of- neovascular (wet) age-related macular degeneration (AMD),- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO),- visual impairment due to diabetic macular oedema (DME),- visual impairment due to myopic choroidal neovascularisation (myopic CNV).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/06/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/08/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/06/2025", "last_updated_date": "04/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vgenfli" }, { "category": "Veterinary", "name_of_medicine": "Bravecto TriUNO", "ema_product_number": "EMEA/V/C/006311", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fluralaner;moxidectin;pyrantel", "active_substance": "fluralaner;moxidectin;pyrantel", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents;Endectocides;Milbemycins;moxidectin, combinations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/10/2024", "last_updated_date": "04/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bravecto-triuno" }, { "category": "Human", "name_of_medicine": "Myalepta", "ema_product_number": "EMEA/H/C/004218", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000304056", "international_non_proprietary_name_common_name": "metreleptin", "active_substance": "Metreleptin", "therapeutic_area_mesh": "Lipodystrophy, Familial Partial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients: with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above with confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A.", "european_commission_decision_date": "03/11/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/05/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/07/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "30/07/2018", "last_updated_date": "03/11/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/myalepta" }, { "category": "Human", "name_of_medicine": "Zurzuvae", "ema_product_number": "EMEA/H/C/006488", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000304502", "international_non_proprietary_name_common_name": "zuranolone", "active_substance": "zuranolone", "therapeutic_area_mesh": "Depression, Postpartum", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06A", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zurzuvae is indicated for the treatment of postpartum depression (PPD) in adults following childbirth (see section 5.1). ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biogen Netherlands B.V.", "european_commission_decision_date": "30/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/07/2025", "last_updated_date": "31/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zurzuvae" }, { "category": "Human", "name_of_medicine": "Januvia", "ema_product_number": "EMEA/H/C/000722", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000309219", "international_non_proprietary_name_common_name": "sitagliptin", "active_substance": "sitagliptin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For adult patients with type-2 diabetes mellitus, Januvia is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome-proliferator-activated-receptor-gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; a PPAR? agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp and Dohme B.V", "european_commission_decision_date": "30/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/03/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "16/05/2018", "last_updated_date": "31/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/januvia" }, { "category": "Human", "name_of_medicine": "Syfovre", "ema_product_number": "EMEA/H/C/005954", "medicine_status": "Refused", "opinion_status": "Negative", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pegcetacoplan", "active_substance": "", "therapeutic_area_mesh": "Macular Degeneration;Geographic Atrophy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA31", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Apellis Europe B.V.", "european_commission_decision_date": "16/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2024", "withdrawal_of_application_date": "04/10/2024", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "16/12/2024", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/01/2024", "last_updated_date": "30/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/syfovre" }, { "category": "Human", "name_of_medicine": "Elonva", "ema_product_number": "EMEA/H/C/001106", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000286664", "international_non_proprietary_name_common_name": "corifollitropin alfa", "active_substance": "corifollitropin alfa", "therapeutic_area_mesh": "Reproductive Techniques, Assisted;Ovulation Induction;Investigative Techniques", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03GA09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. Elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human Chorionic Gonadotropin (hCG).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "30/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/01/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "08/05/2018", "last_updated_date": "30/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elonva" }, { "category": "Human", "name_of_medicine": "Teysuno", "ema_product_number": "EMEA/H/C/001242", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000308441", "international_non_proprietary_name_common_name": "tegafur;gimeracil;oteracil", "active_substance": "tegafur;gimeracil;oteracil", "therapeutic_area_mesh": "Stomach Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC53", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Teysuno is indicated in adults: - for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1). - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Nordic Group B.V.", "european_commission_decision_date": "30/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/03/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "07/03/2018", "last_updated_date": "30/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/teysuno" }, { "category": "Human", "name_of_medicine": "Ristaben", "ema_product_number": "EMEA/H/C/001234", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000309220", "international_non_proprietary_name_common_name": "sitagliptin", "active_substance": "sitagliptin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For adult patients with type-2 diabetes mellitus, Ristaben is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome proliferator-activated-receptor-gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "30/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/12/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/03/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "22/05/2018", "last_updated_date": "30/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ristaben" }, { "category": "Human", "name_of_medicine": "M-M-RVaxPro", "ema_product_number": "EMEA/H/C/000604", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000308492", "international_non_proprietary_name_common_name": "measles, mumps and rubella vaccine (live)", "active_substance": "measles virus Enders’ Edmonston strain (live, attenuated);mumps virus Jeryl Lynn (level B) strain (live, attenuated);rubella virus Wistar RA 27/3 strain (live, attenuated)", "therapeutic_area_mesh": "Rubella;Mumps;Immunization;Measles", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BD52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "M-M-RVaxPro is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months or older. For use in measles outbreaks, or for post-exposure vaccination, or for use in previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "30/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/05/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "19/02/2018", "last_updated_date": "30/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/m-m-rvaxpro" }, { "category": "Human", "name_of_medicine": "Vocabria", "ema_product_number": "EMEA/H/C/004976", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000256925", "international_non_proprietary_name_common_name": "cabotegravir", "active_substance": "cabotegavir sodium;cabotegravir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class for: Oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting cabotegravir injection plus long acting rilpivirine injection. Oral therapy for adults and adolescents who will miss planned dosing with cabotegravir injection plus rilpivirine injection. Vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adoloscents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse trascriptase.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare B.V.", "european_commission_decision_date": "14/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/10/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/12/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "05/01/2021", "last_updated_date": "30/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vocabria" }, { "category": "Human", "name_of_medicine": "Zimbus Breezhaler", "ema_product_number": "EMEA/H/C/005518", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000289953", "international_non_proprietary_name_common_name": "indacaterol;glycopyrronium;mometasone furoate", "active_substance": "glycopyrronium bromide;Indacaterol (acetate);mometasone furoate", "therapeutic_area_mesh": "Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Maintenance treatment of asthma in adults whose disease is not adequately controlled.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "28/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/04/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/07/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "02/09/2020", "last_updated_date": "30/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zimbus-breezhaler" }, { "category": "Human", "name_of_medicine": "Lytgobi", "ema_product_number": "EMEA/H/C/005627", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282565", "international_non_proprietary_name_common_name": "futibatinib", "active_substance": "Futibatinib", "therapeutic_area_mesh": "Cholangiocarcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EN04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Taiho Pharma Netherlands B.V.", "european_commission_decision_date": "18/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/07/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "18/07/2023", "last_updated_date": "29/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lytgobi" }, { "category": "Human", "name_of_medicine": "Rybrevant", "ema_product_number": "EMEA/H/C/005454", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000261993", "international_non_proprietary_name_common_name": "amivantamab", "active_substance": "amivantamab", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rybrevant is indicated: in combination with lazertinib for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations. in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). in combination with carboplatin and pemetrexed for the first line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations. as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum based therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.   ", "european_commission_decision_date": "18/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/10/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "12/10/2021", "last_updated_date": "29/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rybrevant" }, { "category": "Human", "name_of_medicine": "Phesgo", "ema_product_number": "EMEA/H/C/005386", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000258704", "international_non_proprietary_name_common_name": "pertuzumab;trastuzumab", "active_substance": "pertuzumab;trastuzumab", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XY", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Early breast cancer (EBC) Phesgo is indicated for use in combination with chemotherapy in: the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence Metastatic breast cancer (MBC) Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "22/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/11/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/12/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "13/01/2021", "last_updated_date": "28/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/phesgo" }, { "category": "Human", "name_of_medicine": "Votrient", "ema_product_number": "EMEA/H/C/001141", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000307790", "international_non_proprietary_name_common_name": "pazopanib", "active_substance": "pazopanib", "therapeutic_area_mesh": "Carcinoma, Renal Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Renal-cell carcinoma (RCC) Votrient is indicated in adults for the first-line treatment of advanced renal-cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. Soft-tissue sarcoma (STS) Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy. Efficacy and safety have only been established in certain STS histological tumour subtypes.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "28/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/06/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/06/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "08/05/2018", "last_updated_date": "28/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/votrient" }, { "category": "Human", "name_of_medicine": "Abilify Maintena", "ema_product_number": "EMEA/H/C/002755", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000308201", "international_non_proprietary_name_common_name": "aripiprazole", "active_substance": "aripiprazole", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Otsuka Pharmaceutical Netherlands B.V.", "european_commission_decision_date": "27/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "27/08/2018", "last_updated_date": "28/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abilify-maintena" }, { "category": "Human", "name_of_medicine": "Multaq", "ema_product_number": "EMEA/H/C/001043", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000304194", "international_non_proprietary_name_common_name": "dronedarone", "active_substance": "dronedarone", "therapeutic_area_mesh": "Atrial Fibrillation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01BD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Multaq is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile, Multaq should only be prescribed after alternative treatment options have been considered. Multaq should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "28/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/11/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "13/11/2017", "last_updated_date": "28/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/multaq" }, { "category": "Human", "name_of_medicine": "Fanskya", "ema_product_number": "EMEA/H/C/005537", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Mozafancogene autotemcel", "active_substance": "mozafancogene autotemcel", "therapeutic_area_mesh": "Fanconi Anemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": " Treatment of paediatric patients with Fanconi Anaemia Type A", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Rocket Pharmaceuticals B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "22/08/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/08/2025", "last_updated_date": "27/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fanskya" }, { "category": "Human", "name_of_medicine": "Lemtrada", "ema_product_number": "EMEA/H/C/003718", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000304324", "international_non_proprietary_name_common_name": "alemtuzumab", "active_substance": "alemtuzumab", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA34", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Selective immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Belgium", "european_commission_decision_date": "27/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "02/07/2018", "last_updated_date": "27/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lemtrada" }, { "category": "Human", "name_of_medicine": "Elzonris", "ema_product_number": "EMEA/H/C/005031", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000261300", "international_non_proprietary_name_common_name": "tagraxofusp", "active_substance": "tagraxofusp", "therapeutic_area_mesh": "Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX67", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stemline Therapeutics B.V.", "european_commission_decision_date": "17/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/11/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/01/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "25/01/2021", "last_updated_date": "27/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elzonris" }, { "category": "Human", "name_of_medicine": "Emend", "ema_product_number": "EMEA/H/C/000527", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000308121", "international_non_proprietary_name_common_name": "aprepitant", "active_substance": "aprepitant", "therapeutic_area_mesh": "Vomiting;Postoperative Nausea and Vomiting;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A04AD12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiemetics and antinauseants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate Summary of Product Characteristics). Emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. Emend is also available as powder for oral suspension for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years. Emend 80 mg, 125 mg, 165 mg hard capsules and Emend powder for oral suspension are given as part of combination therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "24/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2003", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/11/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "24/05/2018", "last_updated_date": "24/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emend" }, { "category": "Human", "name_of_medicine": "Venclyxto", "ema_product_number": "EMEA/H/C/004106", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000291886", "international_non_proprietary_name_common_name": "venetoclax", "active_substance": "venetoclax", "therapeutic_area_mesh": "Leukemia, Lymphocytic, Chronic, B-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1). Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. Venclyxto monotherapy is indicated for the treatment of CLL: in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor. Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "21/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/12/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "31/05/2018", "last_updated_date": "24/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/venclyxto" }, { "category": "Human", "name_of_medicine": "Columvi", "ema_product_number": "EMEA/H/C/005751", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000270570", "international_non_proprietary_name_common_name": "glofitamab", "active_substance": "Glofitamab", "therapeutic_area_mesh": "Lymphoma, Large B-Cell, Diffuse", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX28", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH ", "european_commission_decision_date": "24/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/07/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "18/07/2023", "last_updated_date": "24/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/columvi" }, { "category": "Human", "name_of_medicine": "Siiltibcy", "ema_product_number": "EMEA/H/C/006177", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000294621", "international_non_proprietary_name_common_name": "Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10)", "active_substance": "Mycobacterium tuberculosis derived antigens (rdESAT‑6 and rCFP‑10)", "therapeutic_area_mesh": "Tuberculosis;Diagnosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V04CF", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Tuberculosis diagnostics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Diagnosis of infection with Mycobacterium tuberculosis.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Serum Life Science Europe GmbH", "european_commission_decision_date": "24/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/01/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "18/10/2024", "last_updated_date": "24/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/siiltibcy" }, { "category": "Human", "name_of_medicine": "Amtagvi", "ema_product_number": "EMEA/H/C/004741", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "lifileucel", "active_substance": "lifileucel", "therapeutic_area_mesh": "Melanoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XL11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of unresectable or metastatic melanoma ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Iovance Biotherapeutics B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "22/07/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/07/2025", "last_updated_date": "23/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amtagvi" }, { "category": "Human", "name_of_medicine": "Vimizim", "ema_product_number": "EMEA/H/C/002779", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0043", "international_non_proprietary_name_common_name": "elosulfase alfa", "active_substance": "recombinant human n-acetylgalactosamine-6-sulfatase", "therapeutic_area_mesh": "Mucopolysaccharidosis IV", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioMarin International Limited", "european_commission_decision_date": "09/04/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/04/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "16/11/2017", "last_updated_date": "23/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vimizim" }, { "category": "Human", "name_of_medicine": "Camzyos", "ema_product_number": "EMEA/H/C/005457", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000266373", "international_non_proprietary_name_common_name": "mavacamten", "active_substance": "Mavacamten", "therapeutic_area_mesh": "Cardiomyopathy, Hypertrophic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01EB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other cardiac preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic obstructive hypertrophic cardiomyopathy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "30/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/06/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "24/07/2023", "last_updated_date": "23/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/camzyos" }, { "category": "Human", "name_of_medicine": "Prolia", "ema_product_number": "EMEA/H/C/001120", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00000954/202409", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Bone Resorption;Osteoporosis, Postmenopausal;Osteoporosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "17/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "04/06/2018", "last_updated_date": "22/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prolia" }, { "category": "Human", "name_of_medicine": "Tygacil", "ema_product_number": "EMEA/H/C/000644", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000262659", "international_non_proprietary_name_common_name": "tigecycline", "active_substance": "tigecycline", "therapeutic_area_mesh": "Bacterial Infections;Skin Diseases, Bacterial;Soft Tissue Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01AA12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections Complicated intra-abdominal infections (cIAI) Tygacil should be used only in situations where other alternative antibiotics are not suitable. Consideration should be given to official guidance on the appropriate use of antibacterial agents. appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "04/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/04/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "30/07/2018", "last_updated_date": "22/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tygacil" }, { "category": "Human", "name_of_medicine": "Livtencity", "ema_product_number": "EMEA/H/C/005787", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000254465", "international_non_proprietary_name_common_name": "maribavir", "active_substance": "Maribavir", "therapeutic_area_mesh": "Cytomegalovirus Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "LIVTENCITY is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT). Consideration should be given to official guidance on the appropriate use of antiviral agents.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland Branch", "european_commission_decision_date": "15/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "14/09/2022", "last_updated_date": "22/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/livtencity" }, { "category": "Human", "name_of_medicine": "Insulin Human Rechon", "ema_product_number": "EMEA/H/C/006011", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "insulin human", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Rechon Life Science AB", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "18/03/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/03/2025", "last_updated_date": "22/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-human-rechon" }, { "category": "Human", "name_of_medicine": "Amsparity", "ema_product_number": "EMEA/H/C/004879", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000289586", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing;Uveitis;Hidradenitis Suppurativa;Colitis, Ulcerative;Crohn Disease;Arthritis, Juvenile Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Amsparity in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Amsparity can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Amsparity in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Amsparity can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Amsparity is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Axial spondyloarthritis Ankylosing spondylitis (AS) Amsparity is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Amsparity is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Amsparity is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Amsparity is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Amsparity is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa Amsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Amsparity is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Amsparity is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Amsparity is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Amsparity is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Adolescent hidradenitis suppurativa Amsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Paediatric uveitis Amsparity is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "16/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/02/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "14/02/2020", "last_updated_date": "22/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amsparity" }, { "category": "Human", "name_of_medicine": "Zonisamide Viatris (previously Zonisamide Mylan)", "ema_product_number": "EMEA/H/C/004127", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000307344", "international_non_proprietary_name_common_name": "zonisamide", "active_substance": "zonisamide", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "21/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/03/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "26/03/2018", "last_updated_date": "22/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zonisamide-viatris" }, { "category": "Human", "name_of_medicine": "Ultomiris", "ema_product_number": "EMEA/H/C/004954", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000271811", "international_non_proprietary_name_common_name": "ravulizumab", "active_substance": "ravulizumab", "therapeutic_area_mesh": "Hemoglobinuria, Paroxysmal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA43", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Selective immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Paroxysmal nocturnal haemoglobinuria (PNH)Ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with PNH:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity.- in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5.1). Atypical haemolytic uremic syndrome (aHUS)Ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with aHUS who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5.1). Generalized myasthenia gravis (gMG)Ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive. Neuromyelitis Optica Spectrum Disorder (NMOSD)Ultomiris is indicated in the treatment of adult patients with NMOSD who are anti-aquaporin 4 (AQP4) antibody-positive (see section 5.1). Ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity.- in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. Ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Alexion Europe SAS", "european_commission_decision_date": "11/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/07/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "10/07/2019", "last_updated_date": "22/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ultomiris" }, { "category": "Human", "name_of_medicine": "Tezspire", "ema_product_number": "EMEA/H/C/005588", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000245013", "international_non_proprietary_name_common_name": "tezepelumab", "active_substance": "tezepelumab", "therapeutic_area_mesh": "Asthma;Sinusitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03DX11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "AsthmaTezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment. Chronic rhinosinusitis with nasal polyps (CRSwNP) Tezspire is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids, and/or surgery do not provide adequate disease control.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "20/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "21/09/2022", "last_updated_date": "22/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tezspire" }, { "category": "Human", "name_of_medicine": "Voriconazole Accord", "ema_product_number": "EMEA/H/C/002669", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296347", "international_non_proprietary_name_common_name": "voriconazole", "active_substance": "voriconazole", "therapeutic_area_mesh": "Aspergillosis;Candidiasis;Mycoses", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use;Triazole and triazole derivatives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "17/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/05/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "08/02/2018", "last_updated_date": "21/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/voriconazole-accord" }, { "category": "Human", "name_of_medicine": "Aqumeldi", "ema_product_number": "EMEA/H/C/005731", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000303474", "international_non_proprietary_name_common_name": "enalapril maleate", "active_substance": "Enalapril (maleate)", "therapeutic_area_mesh": "Heart Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of heart failure.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Proveca Pharma Limited", "european_commission_decision_date": "20/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "15/09/2023", "last_updated_date": "21/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aqumeldi" }, { "category": "Human", "name_of_medicine": "Idacio", "ema_product_number": "EMEA/H/C/004475", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0024/G", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing;Uveitis;Hidradenitis Suppurativa;Colitis, Ulcerative;Crohn Disease;Arthritis, Juvenile Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Idacio in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Idacio in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Idacio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Idacio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Idacio is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Idacio is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Idacio is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Idacio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Idacio is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Idacio is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. Paediatric Uveitis Idacio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "18/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/01/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/04/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "17/04/2019", "last_updated_date": "21/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/idacio" }, { "category": "Human", "name_of_medicine": "Gardasil", "ema_product_number": "EMEA/H/C/000703", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000307068", "international_non_proprietary_name_common_name": "human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)", "active_substance": "human papillomavirus type 6 L1 protein;human papillomavirus type 11 L1 protein;human papillomavirus type 16 L1 protein;human papillomavirus type 18 L1 protein", "therapeutic_area_mesh": "Papillomavirus Infections;Uterine Cervical Dysplasia;Condylomata Acuminata;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BM01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Gardasil is a vaccine for use from the age of 9 years for the prevention of: premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types; genital warts (condyloma acuminata) causally related to specific HPV types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Gardasil should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "20/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/07/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "52", "first_published_date": "17/05/2018", "last_updated_date": "20/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gardasil" }, { "category": "Human", "name_of_medicine": "Herwenda", "ema_product_number": "EMEA/H/C/005769", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000269636", "international_non_proprietary_name_common_name": "trastuzumab", "active_substance": "trastuzumab", "therapeutic_area_mesh": "Breast Neoplasms;Stomach Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "04/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "15/09/2023", "last_updated_date": "20/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/herwenda" }, { "category": "Veterinary", "name_of_medicine": "MiPet Easecto", "ema_product_number": "EMEA/V/C/004732", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "sarolaner", "active_substance": "sarolaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/01/2018", "last_updated_date": "20/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/mipet-easecto" }, { "category": "Human", "name_of_medicine": "Elevidys", "ema_product_number": "EMEA/H/C/005293", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "delandistrogene moxeparvovec", "active_substance": "delandistrogene moxeparvovec", "therapeutic_area_mesh": "Muscular Dystrophy, Duchenne", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of ambulatory patients aged 3 to 7 years old with Duchenne muscular dystrophy", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "24/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "24/09/2025", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/07/2025", "last_updated_date": "20/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elevidys" }, { "category": "Human", "name_of_medicine": "Diacomit", "ema_product_number": "EMEA/H/C/000664", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00002789/202411", "international_non_proprietary_name_common_name": "stiripentol", "active_substance": "stiripentol", "therapeutic_area_mesh": "Myoclonic Epilepsy, Juvenile", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biocodex", "european_commission_decision_date": "21/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/01/2007", "refusal_of_marketing_authorisation_date": "11/02/2009", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "23/06/2014", "last_updated_date": "20/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/diacomit" }, { "category": "Veterinary", "name_of_medicine": "Zycortal", "ema_product_number": "EMEA/V/C/003782", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "desoxycortone", "active_substance": "desoxycortone pivalate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Corticosteroids for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/11/2015", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zycortal" }, { "category": "Veterinary", "name_of_medicine": "Zulvac SBV", "ema_product_number": "EMEA/V/C/002781", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated Schmallenberg virus, strain BH80/11-4", "active_substance": "inactivated Schmallenberg virus, strain BH80/11-4", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zulvac-sbv" }, { "category": "Veterinary", "name_of_medicine": "Zenalpha", "ema_product_number": "EMEA/V/C/005465", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "medetomidine hydrochloride;vatinoxan hydrochloride", "active_substance": "medetomidine hydrochloride;vatinoxan hydrochloride", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Psycholeptics, hypnotics and sedatives", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/10/2021", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zenalpha" }, { "category": "Veterinary", "name_of_medicine": "Virbagen Omega", "ema_product_number": "EMEA/V/C/000061", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "interferon (omega)", "active_substance": "recombinant omega interferon of feline origin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunostimulants", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/12/2016", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/virbagen-omega" }, { "category": "Veterinary", "name_of_medicine": "Veraflox", "ema_product_number": "EMEA/V/C/000159", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pradofloxacin", "active_substance": "pradofloxacin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use;Fluoroquinolones", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/03/2018", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/veraflox" }, { "category": "Veterinary", "name_of_medicine": "Vepured", "ema_product_number": "EMEA/V/C/004364", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "E. coli verotoxoid vaccine (inactivated recombinant)", "active_substance": "recombinant Verotoxin 2e of E. coli", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/08/2017", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vepured" }, { "category": "Veterinary", "name_of_medicine": "Vectra Felis", "ema_product_number": "EMEA/V/C/002746", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pyriproxyfen;dinotefuran", "active_substance": "pyriproxyfen;dinotefuran", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents;Other ectoparasiticides for topical use;pyriproxyfen, combinations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/02/2015", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vectra-felis" }, { "category": "Veterinary", "name_of_medicine": "Vectormune FP ILT + AE", "ema_product_number": "EMEA/V/C/005077", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fowlpox, avian infectious laryngotracheitis vaccine (live, recombinant) and avian encephalomyelitis vaccine (live)", "active_substance": "live recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus (rFP-LT) and avian encephalomyelitis virus, strain Calnek 1143 (AE)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live viral vaccines;Domestic fowl", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "03/09/2020", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vectormune-fp-ilt-ae" }, { "category": "Human", "name_of_medicine": "Zutectra", "ema_product_number": "EMEA/H/C/001089", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000284874", "international_non_proprietary_name_common_name": "human hepatitis B immunoglobulin", "active_substance": "human hepatitis B immunoglobulin", "therapeutic_area_mesh": "Immunization, Passive;Hepatitis B;Liver Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start. The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re-infection prophylaxis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biotest Pharma GmbH", "european_commission_decision_date": "18/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/11/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "17/05/2018", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zutectra" }, { "category": "Human", "name_of_medicine": "Nplate", "ema_product_number": "EMEA/H/C/000942", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000276333", "international_non_proprietary_name_common_name": "romiplostim", "active_substance": "romiplostim", "therapeutic_area_mesh": "Purpura, Thrombocytopenic, Idiopathic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults: Nplate is indicated for the treatment of primary immune thrombocytopenia  (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Paediatrics: Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "04/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/02/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "04/06/2018", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nplate" }, { "category": "Veterinary", "name_of_medicine": "Zulvac BTV", "ema_product_number": "EMEA/V/C/004185", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)", "active_substance": "one of the following inactivated bluetongue virus strains:Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02Inactivated bluetongue virus, serotype 4, strain SPA-1/2004", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals;Immunologicals for Bovidae;Inactivated viral vaccines;bluetongue virus;SHEEP", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/04/2017", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zulvac-btv" }, { "category": "Veterinary", "name_of_medicine": "Zulvac 1+8 Ovis", "ema_product_number": "EMEA/V/C/002251", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated bluetongue serotype 1+8 vaccine", "active_substance": "inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01;inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Inactivated viral vaccines;bluetongue virus;SHEEP", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zulvac-18-ovis" }, { "category": "Veterinary", "name_of_medicine": "Zulvac 1+8 Bovis", "ema_product_number": "EMEA/V/C/002473", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated bluetongue virus, serotypes 1 and 8", "active_substance": "inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP;inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals;Immunologicals for Bovidae;Cattle;Inactivated viral vaccines;bluetongue virus", "therapeutic_indication": "", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zulvac-18-bovis" }, { "category": "Veterinary", "name_of_medicine": "Zulvac 8 Ovis", "ema_product_number": "EMEA/V/C/000147", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated bluetongue virus, serotype 8", "active_substance": "inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zulvac-8-ovis" }, { "category": "Veterinary", "name_of_medicine": "VarroMed", "ema_product_number": "EMEA/V/C/002723", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "oxalic acid dihydrate / formic acid", "active_substance": "oxalic acid dihydrate;formic acid", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for topical use, incl. insecticides", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/08/2018", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/varromed" }, { "category": "Veterinary", "name_of_medicine": "UpCard", "ema_product_number": "EMEA/V/C/003836", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "torasemide", "active_substance": "torasemide anhydrous", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Sulfonamides, plain;High-ceiling diuretics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/07/2015", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/upcard" }, { "category": "Veterinary", "name_of_medicine": "Ultifend ND IBD", "ema_product_number": "EMEA/V/C/005347", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Newcastle disease;infectious bursal disease;Marek's disease vaccine (live recombinant)", "active_substance": "turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/02/2021", "last_updated_date": "15/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/ultifend-nd-ibd" }, { "category": "Veterinary", "name_of_medicine": "Suvaxyn Circo", "ema_product_number": "EMEA/V/C/004242", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "porcine circovirus vaccine (inactivated, recombinant)", "active_substance": "porcine circovirus vaccine (inactivated, recombinant)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "07/02/2018", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/suvaxyn-circo" }, { "category": "Veterinary", "name_of_medicine": "Suvaxyn Circo+MH RTU", "ema_product_number": "EMEA/V/C/003924", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)", "active_substance": "inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein;Inactivated Mycoplasma hyopneumoniae, strain P-5722-3", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Inactivated viral and inactivated bacterial vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/05/2017", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/suvaxyn-circomh-rtu" }, { "category": "Veterinary", "name_of_medicine": "Suiseng Diff/A", "ema_product_number": "EMEA/V/C/005596", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "clostridioides difficile;clostridium perfringens vaccine, inactivated", "active_substance": "Clostridioides difficile toxoid A;Clostridioides difficile toxoid B;Clostridium perfringens, type A, alpha toxoid", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Suidae, inactivated bacterial vaccines for pigs, clostridium", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/10/2021", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/suiseng-diff" }, { "category": "Veterinary", "name_of_medicine": "Stelfonta", "ema_product_number": "EMEA/V/C/005018", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tigilanol tiglate", "active_substance": "tigilanol tiglate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "tigilanol tiglate", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/02/2020", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/stelfonta" }, { "category": "Veterinary", "name_of_medicine": "Sevohale (previously Sevocalm)", "ema_product_number": "EMEA/V/C/004199", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "sevoflurane", "active_substance": "sevoflurane", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anesthetics, general", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/06/2018", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/sevohale" }, { "category": "Veterinary", "name_of_medicine": "Sedadex", "ema_product_number": "EMEA/V/C/004202", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dexmedetomidine", "active_substance": "Dexmedetomidine hydrochloride", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Psycholeptics;Hypnotics and sedatives", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/10/2017", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/sedadex" }, { "category": "Veterinary", "name_of_medicine": "Rabitec", "ema_product_number": "EMEA/V/C/004387", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rabies vaccine (live, oral) for foxes and raccoon dogs", "active_substance": "attenuated live rabies vaccine virus, strain SPBN GASGAS", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for canidae;Live viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/12/2017", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/rabitec" }, { "category": "Human", "name_of_medicine": "Bortezomib Sun", "ema_product_number": "EMEA/H/C/004076", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000302628", "international_non_proprietary_name_common_name": "bortezomib", "active_substance": "bortezomib", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bortezomib SUN as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib SUN in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib SUN in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib SUN in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SUN Pharmaceutical Industries (Europe) B.V.", "european_commission_decision_date": "10/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/07/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "07/09/2017", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bortezomib-sun" }, { "category": "Veterinary", "name_of_medicine": "Ubac", "ema_product_number": "EMEA/V/C/004595", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Streptococcus uberis vaccine (inactivated)", "active_substance": "Lipoteichoic acid from Biofilm Adhesion Component of Streptococcus uberis, strain 5616", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/07/2018", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/ubac" }, { "category": "Veterinary", "name_of_medicine": "Tulissin", "ema_product_number": "EMEA/V/C/005073", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tulathromycin", "active_substance": "tulathromycin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/06/2020", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/tulissin" }, { "category": "Veterinary", "name_of_medicine": "Tulinovet", "ema_product_number": "EMEA/V/C/005076", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tulathromycin", "active_substance": "tulathromycin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use;Macrolides", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/12/2020", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/tulinovet" }, { "category": "Veterinary", "name_of_medicine": "Tulaven", "ema_product_number": "EMEA/V/C/005153", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tulathromycin", "active_substance": "tulathromycin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/06/2020", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/tulaven" }, { "category": "Human", "name_of_medicine": "Menveo", "ema_product_number": "EMEA/H/C/001095", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000269053", "international_non_proprietary_name_common_name": "meningococcal group A, C, W-135 and Y conjugate vaccine", "active_substance": "meningococcal group A, C, W-135 and Y conjugate vaccine", "therapeutic_area_mesh": "Immunization;Meningitis, Meningococcal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AH08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bacterial vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vials Menveo is indicated for active immunisation of children (from two years of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GSK Vaccines S.r.l.", "european_commission_decision_date": "11/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/12/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/03/2010", "refusal_of_marketing_authorisation_date": "17/12/2009", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "15/03/2018", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/menveo" }, { "category": "Veterinary", "name_of_medicine": "Rabigen SAG2", "ema_product_number": "EMEA/V/C/000043", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "live vaccine against rabies", "active_substance": "live attenuated rabies virus, SAG2 strain", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Live viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/12/2016", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/rabigen-sag2" }, { "category": "Veterinary", "name_of_medicine": "Rhiniseng", "ema_product_number": "EMEA/V/C/000160", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated vaccine to prevent progressive and non-progressive atrophic rhinitis in pigs", "active_substance": "inactivated Bordetella bronchiseptica, strain 833CER;recombinant type-D Pasteurella-multocida toxin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/06/2017", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/rhiniseng" }, { "category": "Veterinary", "name_of_medicine": "Rexxolide", "ema_product_number": "EMEA/V/C/005384", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tulathromycin", "active_substance": "tulathromycin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/03/2021", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/rexxolide" }, { "category": "Veterinary", "name_of_medicine": "Respiporc FLUpan H1N1", "ema_product_number": "EMEA/V/C/003993", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "porcine influenza vaccine (inactivated)", "active_substance": "Influenza A virus/human strain: A/Jena/VI5258/2009 (H1N1)pdm09, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals, inactivated viral vaccines for pigs, porcine influenza virus", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/05/2017", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/respiporc-flupan-h1n1" }, { "category": "Human", "name_of_medicine": "Arikayce liposomal", "ema_product_number": "EMEA/H/C/005264", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000284843", "international_non_proprietary_name_common_name": "amikacin", "active_substance": "amikacin sulfate", "therapeutic_area_mesh": "Respiratory Tract Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01GB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Insmed Netherlands B.V.", "european_commission_decision_date": "18/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/10/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "18/11/2020", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/arikayce-liposomal" }, { "category": "Veterinary", "name_of_medicine": "Quadrisol", "ema_product_number": "EMEA/V/C/000032", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0037", "international_non_proprietary_name_common_name": "vedaprofen", "active_substance": "vedaprofen", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/04/2017", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/quadrisol" }, { "category": "Human", "name_of_medicine": "Okedi", "ema_product_number": "EMEA/H/C/005406", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296174", "international_non_proprietary_name_common_name": "risperidone", "active_substance": "risperidone", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratorios Farmacéuticos Rovi, S.A.", "european_commission_decision_date": "11/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "15/12/2021", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/okedi" }, { "category": "Veterinary", "name_of_medicine": "Respiporc Flu3", "ema_product_number": "EMEA/V/C/000153", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated influenza-A virus", "active_substance": "inactivated influenza-A virus / swine", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "07/09/2017", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/respiporc-flu3" }, { "category": "Veterinary", "name_of_medicine": "ReproCyc ParvoFLEX", "ema_product_number": "EMEA/V/C/004858", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "porcine parvovirosis vaccine (inactivated)", "active_substance": "Porcine parvovirus, strain 27a, viral protein 2", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2019", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/reprocyc-parvoflex" }, { "category": "Veterinary", "name_of_medicine": "Reconcile", "ema_product_number": "EMEA/V/C/000133", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fluoxetine", "active_substance": "fluoxetine", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Psychoanaleptics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/07/2018", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/reconcile" }, { "category": "Veterinary", "name_of_medicine": "ProZinc", "ema_product_number": "EMEA/V/C/002634", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "insulin human", "active_substance": "insulin human", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Insulins and analogues for injection, intermediate-acting", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/04/2018", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/prozinc" }, { "category": "Human", "name_of_medicine": "Evusheld", "ema_product_number": "EMEA/H/C/005788", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0019", "international_non_proprietary_name_common_name": "tixagevimab;cilgavimab", "active_substance": "tixagevimab;cilgavimab", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of COVID-19.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "11/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/03/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/03/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "12/09/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "30/03/2022", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evusheld" }, { "category": "Veterinary", "name_of_medicine": "Profender", "ema_product_number": "EMEA/V/C/000097", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "emodepside;praziquantel", "active_substance": "emodepside;praziquantel", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/03/2018", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/profender" }, { "category": "Veterinary", "name_of_medicine": "Procox", "ema_product_number": "EMEA/V/C/002006", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "emodepside;toltrazuril", "active_substance": "emodepside;toltrazuril", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/03/2018", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/procox" }, { "category": "Veterinary", "name_of_medicine": "Prevomax", "ema_product_number": "EMEA/V/C/004331", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "maropitant", "active_substance": "maropitant", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Alimentary tract and metabolism;Other antiemetics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/01/2018", "last_updated_date": "14/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/prevomax" }, { "category": "Human", "name_of_medicine": "Oxlumo", "ema_product_number": "EMEA/H/C/005040", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000245133", "international_non_proprietary_name_common_name": "lumasiran", "active_substance": "Lumasiran sodium", "therapeutic_area_mesh": "Hyperoxaluria, Primary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of primary hyperoxaluria type 1 (PH1) in all age groups.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Alnylam Netherlands B.V.", "european_commission_decision_date": "04/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/10/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "25/11/2020", "last_updated_date": "13/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/oxlumo" }, { "category": "Human", "name_of_medicine": "Mycamine", "ema_product_number": "EMEA/H/C/000734", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000290203", "international_non_proprietary_name_common_name": "micafungin", "active_substance": "micafungin", "therapeutic_area_mesh": "Candidiasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mycamine is indicated for: Adults, adolescents ≥ 16 years of age and elderly treatment of invasive candidiasis; treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate; prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. Children (including neonates) and adolescents < 16 years of age treatment of invasive candidiasis. prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. The decision to use Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz Pharmaceuticals d.d.", "european_commission_decision_date": "04/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/04/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "19/02/2018", "last_updated_date": "13/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mycamine" }, { "category": "Veterinary", "name_of_medicine": "Prac-tic", "ema_product_number": "EMEA/V/C/000103", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pyriprole", "active_substance": "pyriprole", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for topical use, incl. insecticides", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/08/2018", "last_updated_date": "13/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/prac-tic" }, { "category": "Veterinary", "name_of_medicine": "Posatex", "ema_product_number": "EMEA/V/C/000122", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "orbifloxacin;mometasone furoate;posaconazole", "active_substance": "orbifloxacin;mometasone furoate;posaconazole", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Otologicals", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/05/2013", "last_updated_date": "13/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/posatex" }, { "category": "Human", "name_of_medicine": "Teriparatide Sun", "ema_product_number": "EMEA/H/C/005793", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/N/0000295825", "international_non_proprietary_name_common_name": "teriparatide", "active_substance": "teriparatide", "therapeutic_area_mesh": "Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Teriparatide SUN is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "09/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/11/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "14/09/2022", "last_updated_date": "10/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/teriparatide-sun" }, { "category": "Veterinary", "name_of_medicine": "Novem", "ema_product_number": "EMEA/V/C/000086", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QM01AC06", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/09/2017", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/novem" }, { "category": "Veterinary", "name_of_medicine": "Oncept IL-2", "ema_product_number": "EMEA/V/C/002562", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "feline interleukin-2 recombinant canarypox virus (vCP1338 virus)", "active_substance": "Canarypox virus, strain vCP1338, expressing feline interleukin-2 gene, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS;Immunostimulants;Immunostimulants", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/03/2018", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/oncept-il-2" }, { "category": "Veterinary", "name_of_medicine": "Osurnia", "ema_product_number": "EMEA/V/C/003753", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "terbinafine;florfenicol;betamethasone", "active_substance": "betamethasone acetate;terbinafine;florfenicol", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Corticosteroids and antiinfectives in combination", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "03/07/2017", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/osurnia" }, { "category": "Veterinary", "name_of_medicine": "Nobilis IB Primo QX", "ema_product_number": "EMEA/V/C/002802", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian infectious bronchitis virus strain D388", "active_substance": "live avian infectious bronchitis virus, strain D388", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Live viral vaccines;Domestic fowl", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "04/12/2016", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-ib-primo-qx" }, { "category": "Veterinary", "name_of_medicine": "Nobivac Bb", "ema_product_number": "EMEA/V/C/000068", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "live vaccine against Bordetella bronchiseptica in cats", "active_substance": "live Bordetella bronchiseptica bacteria strain B-C2", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for felidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/10/2014", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobivac-bb" }, { "category": "Veterinary", "name_of_medicine": "Novaquin", "ema_product_number": "EMEA/V/C/003866", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Oxicams", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/01/2016", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/novaquin" }, { "category": "Veterinary", "name_of_medicine": "Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli)", "ema_product_number": "EMEA/V/C/000024", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "vaccine to provide passive immunity to the progeny against E. coli in pigs", "active_substance": "F4ab (K88ab) fimbrial adhesin;F4ac (K88ac) fimbrial adhesin;F5 (K99) fimbrial adhesin;F6 (987P) fimbrial adhesin;LT toxoid", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "04/04/2014", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/porcilis-porcoli-diluvac-forte" }, { "category": "Veterinary", "name_of_medicine": "Porcilis AR-T DF", "ema_product_number": "EMEA/V/C/000055", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "adjuvanted vaccine against progressive atrophic rhinitis in piglets", "active_substance": "protein dO (non-toxic deletion derivative of Pasteurella multocida dermonecrotic toxin);inactivated Bordetella bronchiseptica cells", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/04/2014", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/porcilis-ar-t-df" }, { "category": "Veterinary", "name_of_medicine": "Melosus", "ema_product_number": "EMEA/V/C/002001", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Musculo-skeletal system", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "07/01/2016", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/melosus" }, { "category": "Veterinary", "name_of_medicine": "Meloxidolor", "ema_product_number": "EMEA/V/C/002590", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Oxicams", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/04/2018", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/meloxidolor" }, { "category": "Veterinary", "name_of_medicine": "Meloxidyl", "ema_product_number": "EMEA/V/C/000115", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Oxicams", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/01/2018", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/meloxidyl" }, { "category": "Veterinary", "name_of_medicine": "Pexion", "ema_product_number": "EMEA/V/C/002543", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "imepitoin", "active_substance": "imepitoin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Other antiepileptics;Antiepileptics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "05/07/2018", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/pexion" }, { "category": "Veterinary", "name_of_medicine": "Loxicom", "ema_product_number": "EMEA/V/C/000141", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products, non-steroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/07/2016", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/loxicom" }, { "category": "Veterinary", "name_of_medicine": "Lydaxx", "ema_product_number": "EMEA/V/C/005199", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tulathromycin", "active_substance": "tulathromycin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/08/2020", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/lydaxx" }, { "category": "Veterinary", "name_of_medicine": "Masivet", "ema_product_number": "EMEA/V/C/000128", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "masitinib mesilate", "active_substance": "Masitinib mesilate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antineoplastic agents", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/09/2013", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/masivet" }, { "category": "Human", "name_of_medicine": "Fulvestrant Mylan", "ema_product_number": "EMEA/H/C/004649", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000303636", "international_non_proprietary_name_common_name": "fulvestrant", "active_substance": "fulvestrant", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on antiestrogen therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "09/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "08/01/2018", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fulvestrant-mylan" }, { "category": "Veterinary", "name_of_medicine": "Nasym", "ema_product_number": "EMEA/V/C/004897", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bovine respiratory syncytial virus vaccine (live)", "active_substance": "live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae;Cattle;Live viral vaccines;bovine respiratory syncytial virus (BRSV)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/07/2019", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nasym" }, { "category": "Veterinary", "name_of_medicine": "MS-H Vaccine", "ema_product_number": "EMEA/V/C/000161", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Mycoplasma synoviae (live)", "active_substance": "Mycoplasma synoviae strain MS-H", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live bacterial vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/05/2016", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/ms-h-vaccine" }, { "category": "Veterinary", "name_of_medicine": "Mirataz", "ema_product_number": "EMEA/V/C/004733", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "mirtazapine", "active_substance": "mirtazapine", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Psychoanaleptics;Antidepressants in combination with psycholeptics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/01/2020", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/mirataz" }, { "category": "Human", "name_of_medicine": "Adasuve", "ema_product_number": "EMEA/H/C/002400", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010113/202408", "international_non_proprietary_name_common_name": "loxapine", "active_substance": "loxapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Nervous system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ferrer Internacional S.A.", "european_commission_decision_date": "01/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/02/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "15/01/2018", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adasuve" }, { "category": "Human", "name_of_medicine": "Memantine Accord", "ema_product_number": "EMEA/H/C/002766", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000302702", "international_non_proprietary_name_common_name": "memantine", "active_substance": "memantine hydrochloride", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other anti-dementia drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with moderate to severe Alzheimer’s disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "08/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/09/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/12/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "08/08/2017", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/memantine-accord" }, { "category": "Veterinary", "name_of_medicine": "Neptra", "ema_product_number": "EMEA/V/C/004735", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0006", "international_non_proprietary_name_common_name": "florfenicol;terbinafine hydrochloride;mometasone furoate", "active_substance": "florfenicol;terbinafine hydrochloride;mometasone furoate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Otologicals;Corticosteroids and antiinfectives in combination", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/01/2020", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/neptra" }, { "category": "Veterinary", "name_of_medicine": "OvuGel", "ema_product_number": "EMEA/V/C/005219", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "triptorelin", "active_substance": "triptorelin acetate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Pituitary and hypothalamic hormones and analogues", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "07/05/2021", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/ovugel" }, { "category": "Veterinary", "name_of_medicine": "Oxyglobin", "ema_product_number": "EMEA/V/C/000045", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0025/G", "international_non_proprietary_name_common_name": "haemoglobin glutamer-200 (bovine)", "active_substance": "haemoglobin glutamer-200 (bovine)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "03/09/2015", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/oxyglobin" }, { "category": "Human", "name_of_medicine": "Zadenvi", "ema_product_number": "EMEA/H/C/006377", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296770", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, ZADENVI significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva k.s.", "european_commission_decision_date": "03/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/04/2025", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zadenvi" }, { "category": "Veterinary", "name_of_medicine": "Locatim (previously Serinucoli)", "ema_product_number": "EMEA/V/C/000041", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "locatim, oral solution for neonatal calves less than 12 hours of age", "active_substance": "Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/06/2013", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/locatim" }, { "category": "Veterinary", "name_of_medicine": "Letifend", "ema_product_number": "EMEA/V/C/003865", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "canine leishmaniasis vaccine (recombinant protein)", "active_substance": "recombinant protein Q from Leishmania infantum MON-1", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/11/2017", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/letifend" }, { "category": "Veterinary", "name_of_medicine": "Kriptazen", "ema_product_number": "EMEA/V/C/004868", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "halofuginone", "active_substance": "halofuginone", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiprotozoals", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/03/2019", "last_updated_date": "09/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/kriptazen" }, { "category": "Veterinary", "name_of_medicine": "Ingelvac CircoFLEX", "ema_product_number": "EMEA/V/C/000126", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated porcine circovirus vaccine", "active_substance": "porcine circovirus type 2 ORF2 protein", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/11/2017", "last_updated_date": "08/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/ingelvac-circoflex" }, { "category": "Human", "name_of_medicine": "Azacitidine Accord", "ema_product_number": "EMEA/H/C/005147", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000302046", "international_non_proprietary_name_common_name": "azacitidine", "active_substance": "azacitidine", "therapeutic_area_mesh": "Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Azacitidine Accord is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: - intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), - chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder, - acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification, - AML with >30% marrow blasts according to the WHO classification.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "07/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/02/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "21/02/2020", "last_updated_date": "08/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/azacitidine-accord" }, { "category": "Veterinary", "name_of_medicine": "Inflacam", "ema_product_number": "EMEA/V/C/002497", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products, non-steroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/10/2016", "last_updated_date": "08/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/inflacam" }, { "category": "Human", "name_of_medicine": "Briumvi", "ema_product_number": "EMEA/H/C/005914", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000279394", "international_non_proprietary_name_common_name": "ublituximab", "active_substance": "ublituximab", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Neuraxpharm Pharmaceuticals S.L.", "european_commission_decision_date": "04/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/05/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "31/05/2023", "last_updated_date": "08/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/briumvi" }, { "category": "Human", "name_of_medicine": "Tecvayli", "ema_product_number": "EMEA/H/C/005865", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000254941", "international_non_proprietary_name_common_name": "teclistamab", "active_substance": "teclistamab", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01F", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "TECVAYLI is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.", "european_commission_decision_date": "12/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "18/07/2022", "last_updated_date": "08/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tecvayli" }, { "category": "Veterinary", "name_of_medicine": "Isemid", "ema_product_number": "EMEA/V/C/004345", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "torasemide", "active_substance": "torasemide", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "High-ceiling diuretics;Sulfonamides, plain", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "07/02/2019", "last_updated_date": "08/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/isemid" }, { "category": "Human", "name_of_medicine": "Ekterly", "ema_product_number": "EMEA/H/C/006211", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "sebetralstat", "active_substance": "sebetralstat", "therapeutic_area_mesh": "Angioedemas, Hereditary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AC08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ekterly is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. ", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Kalvista Pharmaceuticals (Ireland) Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/07/2025", "last_updated_date": "08/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ekterly" }, { "category": "Human", "name_of_medicine": "Bemrist Breezhaler", "ema_product_number": "EMEA/H/C/005516", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000303707", "international_non_proprietary_name_common_name": "indacaterol;mometasone", "active_substance": "indacaterol;mometasone furoate", "therapeutic_area_mesh": "Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bemrist Breezhaler is indicated as a maintenance   treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "07/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/05/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "24/06/2020", "last_updated_date": "07/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bemrist-breezhaler" }, { "category": "Human", "name_of_medicine": "Selincro", "ema_product_number": "EMEA/H/C/002583", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000302832", "international_non_proprietary_name_common_name": "nalmefene", "active_substance": "nalmefene hydrochloride dihydrate", "therapeutic_area_mesh": "Alcohol-Related Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07BB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in alcohol dependence", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification. Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "H. Lundbeck A/S", "european_commission_decision_date": "07/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/02/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "08/12/2017", "last_updated_date": "07/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/selincro" }, { "category": "Human", "name_of_medicine": "Benlysta", "ema_product_number": "EMEA/H/C/002015", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000286149", "international_non_proprietary_name_common_name": "belimumab", "active_substance": "belimumab", "therapeutic_area_mesh": "Lupus Erythematosus, Systemic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AG04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti‑dsDNA and low complement) despite standard therapy. Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis. Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "25/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/07/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "10/11/2017", "last_updated_date": "07/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/benlysta" }, { "category": "Veterinary", "name_of_medicine": "Halocur", "ema_product_number": "EMEA/V/C/000040", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "halofuginone", "active_substance": "halofuginone", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiprotozoals", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/11/2009", "last_updated_date": "07/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/halocur" }, { "category": "Veterinary", "name_of_medicine": "Galliprant", "ema_product_number": "EMEA/V/C/004222", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "grapiprant", "active_substance": "grapiprant", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Other antiinflammatory and antirheumatic agents, non-steroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/05/2018", "last_updated_date": "07/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/galliprant" }, { "category": "Veterinary", "name_of_medicine": "Halagon", "ema_product_number": "EMEA/V/C/004201", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "halofuginone", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "halofuginone;Other antiprotozoal agents", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/02/2018", "last_updated_date": "07/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/halagon" }, { "category": "Human", "name_of_medicine": "Aplidin", "ema_product_number": "EMEA/H/C/004354", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "plitidepsin", "active_substance": "plitidepsin", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of multiple myeloma ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharma Mar S.A.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/07/2025", "last_updated_date": "06/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aplidin" }, { "category": "Human", "name_of_medicine": "Rixathon", "ema_product_number": "EMEA/H/C/003903", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249103", "international_non_proprietary_name_common_name": "rituximab", "active_substance": "rituximab", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;Leukemia, Lymphocytic, Chronic, B-Cell;Wegener Granulomatosis;Microscopic Polyangiitis;Pemphigus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rixathon is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Rixathon is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy. Rixathon maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. Rixathon monotherapy is indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. Rixathon is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Rixathon in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ? 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL). Chronic lymphocytic leukaemia (CLL) Rixathon in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy. See section 5.1 for further information. Rheumatoid arthritis Rixathon in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. Rituximab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Granulomatosis with polyangiitis and microscopic polyangiitis Rixathon, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). Rixathon, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ? 2 to < 18 years old) with severe, active GPA (Wegener’s) and MPA. Pemphigus vulgaris Rixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "10/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/06/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "12/07/2018", "last_updated_date": "06/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rixathon" }, { "category": "Human", "name_of_medicine": "Tyenne", "ema_product_number": "EMEA/H/C/005781", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296005", "international_non_proprietary_name_common_name": "tocilizumab", "active_substance": "tocilizumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Cytokine Release Syndrome;Arthritis, Juvenile Rheumatoid;COVID-19 virus infection;Giant Cell Arteritis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tyenne, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Tyenne is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Tyenne can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Tyenne in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Tyenne is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older. Tyenne is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "02/10/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "07/08/2023", "last_updated_date": "02/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tyenne" }, { "category": "Human", "name_of_medicine": "Takhzyro", "ema_product_number": "EMEA/H/C/004806", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0040", "international_non_proprietary_name_common_name": "lanadelumab", "active_substance": "lanadelumab", "therapeutic_area_mesh": "Angioedemas, Hereditary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland Branch", "european_commission_decision_date": "25/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "17/12/2018", "last_updated_date": "02/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/takhzyro" }, { "category": "Human", "name_of_medicine": "Nidlegy", "ema_product_number": "EMEA/H/C/005651", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bifikafusp alfa;onfekafusp alfa", "active_substance": "bifikafusp alfa;onfekafusp alfa", "therapeutic_area_mesh": "Melanoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XY", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Neoadjuvant treatment of adult patients with locally advanced fully resectable melanoma ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Philogen S.p.A.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "24/06/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/07/2025", "last_updated_date": "01/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nidlegy" }, { "category": "Human", "name_of_medicine": "Farydak", "ema_product_number": "EMEA/H/C/003725", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0030", "international_non_proprietary_name_common_name": "panobinostat", "active_substance": "panobinostat lactate anhydrous", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent. Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "pharmaand GmbH", "european_commission_decision_date": "28/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/08/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "18/06/2018", "last_updated_date": "01/10/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/farydak" }, { "category": "Human", "name_of_medicine": "Deferasirox Accord", "ema_product_number": "EMEA/H/C/005156", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000295785", "international_non_proprietary_name_common_name": "deferasirox", "active_substance": "deferasirox", "therapeutic_area_mesh": "Iron Overload;beta-Thalassemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products;Iron chelating agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older. Deferasirox Accord is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) aged 2 to 5 years, in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, in adult and paediatric patients with other anaemias aged 2 years and older. Deferasirox Accord is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "30/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "04/03/2020", "last_updated_date": "30/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/deferasirox-accord" }, { "category": "Human", "name_of_medicine": "Sitagliptin / Metformin hydrochloride Mylan", "ema_product_number": "EMEA/H/C/005678", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000302331", "international_non_proprietary_name_common_name": "sitagliptin hydrochloride monohydrate;metformin hydrochloride", "active_substance": "sitagliptin hydrochloride monohydrate;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin hydrochloride Mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Sitagliptin/Metformin hydrochloride Mylan is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Sitagliptin/Metformin hydrochloride Mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARg) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARg agonist. Sitagliptin/Metformin hydrochloride Mylan is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "30/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/02/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "14/12/2021", "last_updated_date": "30/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-metformin-hydrochloride-mylan" }, { "category": "Human", "name_of_medicine": "Maapliv", "ema_product_number": "EMEA/H/C/005557", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "amino acids", "active_substance": "glycine,L-alanine,L-arginine,L-aspartic acid,L-cysteine hydrochloride monohydrate,L-histidine,L-methionine,L-phenylalanine,L-proline,L-serine,L-threonine,L-tryptophan,L-tyrosine,L-glutamic acid,L-lysine monohydrate,taurine", "therapeutic_area_mesh": "Maple Syrup Urine Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B05BA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Blood substitutes and perfusion solutions", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Maapliv is indicated for the treatment of maple syrup urine disease (MSUD) presenting with an acute decompensation episode in patients from birth who are not eligible for an oral and enteral branched-chain amino acids free (BCAA- free) formulation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Rare Diseases", "european_commission_decision_date": "28/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/07/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/05/2025", "last_updated_date": "30/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/maapliv" }, { "category": "Human", "name_of_medicine": "Jevtana", "ema_product_number": "EMEA/H/C/002018", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000295586", "international_non_proprietary_name_common_name": "cabazitaxel", "active_substance": "cabazitaxel", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "30/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/01/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/03/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "22/01/2018", "last_updated_date": "30/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jevtana" }, { "category": "Human", "name_of_medicine": "Riltrava Aerosphere", "ema_product_number": "EMEA/H/C/005311", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000295901", "international_non_proprietary_name_common_name": "formoterol fumarate dihydrate;glycopyrronium;budesonide", "active_substance": "Budesonide;formoterol fumarate dihydrate;glycopyrronium bromide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Riltrava Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2 agonist or combination of a long-acting beta2 agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "30/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/11/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/01/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "10/11/2021", "last_updated_date": "30/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/riltrava-aerosphere" }, { "category": "Human", "name_of_medicine": "Orgovyx", "ema_product_number": "EMEA/H/C/005353", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000295448", "international_non_proprietary_name_common_name": "relugolix", "active_substance": "relugolix", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "29/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/04/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "22/02/2022", "last_updated_date": "30/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orgovyx" }, { "category": "Human", "name_of_medicine": "Hexyon", "ema_product_number": "EMEA/H/C/002796", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000296772", "international_non_proprietary_name_common_name": "diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)", "active_substance": "filamentous haemagglutinin;Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate);hepatitis B surface antigen;pertussis toxoid;poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells;poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells;poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells;tetanus protein;tetanus toxoid adsorbed on aluminium hydroxide, hydrated;Diphtheria toxoid", "therapeutic_area_mesh": "Hepatitis B;Tetanus;Immunization;Meningitis, Haemophilus;Whooping Cough;Poliomyelitis;Diphtheria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07CA09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hexyon (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "26/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/02/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/04/2013", "refusal_of_marketing_authorisation_date": "22/02/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "08/12/2017", "last_updated_date": "29/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hexyon" }, { "category": "Human", "name_of_medicine": "Hexacima", "ema_product_number": "EMEA/H/C/002702", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000296775", "international_non_proprietary_name_common_name": "diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)", "active_substance": "hepatitis B surface antigen;Diphtheria toxoid;Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin;poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett);Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein;tetanus toxoid", "therapeutic_area_mesh": "Hepatitis B;Tetanus;Immunization;Meningitis, Haemophilus;Whooping Cough;Poliomyelitis;Diphtheria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07CA09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines;Bacterial and viral vaccines, combined", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hexacima (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "26/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/02/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/04/2013", "refusal_of_marketing_authorisation_date": "22/02/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "08/01/2018", "last_updated_date": "29/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hexacima" }, { "category": "Human", "name_of_medicine": "Deferasirox Mylan", "ema_product_number": "EMEA/H/C/005014", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000268284", "international_non_proprietary_name_common_name": "deferasirox", "active_substance": "deferasirox", "therapeutic_area_mesh": "Iron Overload;beta-Thalassemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Iron chelating agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Deferasirox Mylan is indicated for the treatment of chronic iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) aged 2 to 5 years, in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, in adult and paediatric patients with other anaemias aged 2 years and older. the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion dependent thalassaemia syndromes aged 10 years and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "30/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/09/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "10/10/2019", "last_updated_date": "29/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/deferasirox-mylan" }, { "category": "Human", "name_of_medicine": "Zefylti", "ema_product_number": "EMEA/H/C/006400", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296307", "international_non_proprietary_name_common_name": "filgrastim", "active_substance": "filgrastim", "therapeutic_area_mesh": "Neutropenia;Hematopoietic Stem Cell Transplantation;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zefylti is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Zefylti are similar in adults and children receiving cytotoxic chemotherapy. Zefylti is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Zefylti is indicated to increase neutrophil counts and to reduce the incidence and duration of infection related events. Zefylti is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1 x  109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CuraTeQ Biologics s.r.o", "european_commission_decision_date": "26/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "13/12/2024", "last_updated_date": "29/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zefylti" }, { "category": "Human", "name_of_medicine": "Truxima", "ema_product_number": "EMEA/H/C/004112", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000290253", "international_non_proprietary_name_common_name": "rituximab", "active_substance": "rituximab", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;Wegener Granulomatosis;Leukemia, Lymphocytic, Chronic, B-Cell;Microscopic Polyangiitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Truxima is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Truxima is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy. Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Truxima monotherapy is indicated for treatment of patients with stage III IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy. Truxima is indicated for the treatment of patients with CD20 positive diffuse large B cell non Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Chronic lymphocytic leukaemia (CLL) Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Truxima or patients refractory to previous Truxima plus chemotherapy. Rheumatoid arthritis Truxima in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease modifying anti rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. Truxima has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function, when given in combination with methotrexate. Granulomatosis with polyangiitis and microscopic polyangiitis Truxima, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). Pemphigus vulgaris Truxima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "25/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/02/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "17/05/2018", "last_updated_date": "29/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/truxima" }, { "category": "Human", "name_of_medicine": "Empliciti", "ema_product_number": "EMEA/H/C/003967", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000300473", "international_non_proprietary_name_common_name": "elotuzumab", "active_substance": "Elotuzumab", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "25/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/05/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "13/07/2017", "last_updated_date": "29/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/empliciti" }, { "category": "Human", "name_of_medicine": "ellaOne", "ema_product_number": "EMEA/H/C/001027", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000301541", "international_non_proprietary_name_common_name": "ulipristal acetate", "active_substance": "ulipristal", "therapeutic_area_mesh": "Contraception, Postcoital", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03AD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system;Emergency contraceptives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Emergency contraception within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoire HRA Pharma", "european_commission_decision_date": "25/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/05/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "22/08/2018", "last_updated_date": "29/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ellaone" }, { "category": "Human", "name_of_medicine": "Blitzima", "ema_product_number": "EMEA/H/C/004723", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000290253", "international_non_proprietary_name_common_name": "rituximab", "active_substance": "rituximab", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Blitzima is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Blitzima is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy. Blitzima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Blitzima monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy. Blitzima is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Chronic lymphocytic leukaemia (CLL) Blitzima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Blitzima or patients refractory to previous Blitzima plus chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "25/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/05/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "17/05/2018", "last_updated_date": "29/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/blitzima" }, { "category": "Human", "name_of_medicine": "Ibandronic acid Accord", "ema_product_number": "EMEA/H/C/002638", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000300801", "international_non_proprietary_name_common_name": "ibandronic acid", "active_substance": "ibandronic acid", "therapeutic_area_mesh": "Wounds and Injuries;Breast Diseases;Neoplastic Processes;Calcium Metabolism Disorders;Water-Electrolyte Imbalance", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ibandronic acid is indicated in adults for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour induced hypercalcaemia with or without metastases. Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "25/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/11/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "18/09/2017", "last_updated_date": "26/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ibandronic-acid-accord" }, { "category": "Human", "name_of_medicine": "Tigecycline Accord", "ema_product_number": "EMEA/H/C/005114", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000300796", "international_non_proprietary_name_common_name": "tigecycline", "active_substance": "tigecycline", "therapeutic_area_mesh": "Soft Tissue Infections;Intraabdominal Infections;Bacterial Infections;Skin Diseases, Infectious", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01AA12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tygecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1): Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4) Complicated intra-abdominal infections (cIAI) Tygecycline Accord should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "25/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/04/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "24/04/2020", "last_updated_date": "26/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tigecycline-accord" }, { "category": "Human", "name_of_medicine": "Prasugrel Viatris (previously Prasugrel Mylan)", "ema_product_number": "EMEA/H/C/004644", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296778", "international_non_proprietary_name_common_name": "prasugrel", "active_substance": "prasugrel besilate", "therapeutic_area_mesh": "Myocardial Infarction;Acute Coronary Syndrome;Angina, Unstable", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prasugrel Viatris, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "22/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/05/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "16/05/2018", "last_updated_date": "26/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prasugrel-viatris" }, { "category": "Human", "name_of_medicine": "Grastofil", "ema_product_number": "EMEA/H/C/002150", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0039", "international_non_proprietary_name_common_name": "filgrastim", "active_substance": "filgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Grastofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Grastofil are similar in adults and children receiving cytotoxic chemotherapy. Grastofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Grastofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "22/12/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2003", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/10/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/01/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "26/06/2018", "last_updated_date": "26/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/grastofil" }, { "category": "Human", "name_of_medicine": "Alhemo", "ema_product_number": "EMEA/H/C/005938", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000244862", "international_non_proprietary_name_common_name": "concizumab", "active_substance": "concizumab", "therapeutic_area_mesh": "Hemophilia A;Hemophilia B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BX10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Alhemo is indicated for routine prophylaxis of bleeding in patients 12 years of age or more with: •    haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors.•    severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without FVIII inhibitors.•    haemophilia B (congenital factor IX deficiency) with FIX inhibitors.•    moderate/severe haemophilia B (congenital factor IX deficiency, FIX ≤ 2%) without FIX inhibitors.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "22/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/12/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "18/10/2024", "last_updated_date": "25/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alhemo" }, { "category": "Veterinary", "name_of_medicine": "Equilis EHV 1+4", "ema_product_number": "EMEA/V/C/006147", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Equine herpesvirus vaccine (inactivated)", "active_substance": "equine herpesvirus 1, strain RAC-H and equine herpesvirus 4, strain 2252", "therapeutic_area_mesh": "", "species_veterinary": "Horses", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI05AA05", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "19/07/2024", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/09/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/equilis-ehv-14" }, { "category": "Human", "name_of_medicine": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "ema_product_number": "EMEA/H/C/002022", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000300720", "international_non_proprietary_name_common_name": "mercaptopurine", "active_substance": "6-mercaptopurine monohydrate", "therapeutic_area_mesh": "Leukemia, Lymphoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lipomed GmbH", "european_commission_decision_date": "24/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/03/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "13/07/2017", "last_updated_date": "25/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xaluprine" }, { "category": "Human", "name_of_medicine": "Karvezide", "ema_product_number": "EMEA/H/C/000221", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000265130", "international_non_proprietary_name_common_name": "irbesartan;hydrochlorothiazide", "active_substance": "irbesartan;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "18/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/10/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "51", "first_published_date": "24/08/2017", "last_updated_date": "25/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/karvezide" }, { "category": "Human", "name_of_medicine": "CoAprovel", "ema_product_number": "EMEA/H/C/000222", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000265130", "international_non_proprietary_name_common_name": "irbesartan;hydrochlorothiazide", "active_substance": "irbesartan;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "18/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/07/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/10/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "53", "first_published_date": "22/08/2017", "last_updated_date": "25/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/coaprovel" }, { "category": "Human", "name_of_medicine": "Padcev", "ema_product_number": "EMEA/H/C/005392", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010989/202412", "international_non_proprietary_name_common_name": "enfortumab vedotin", "active_substance": "Enfortumab vedotin", "therapeutic_area_mesh": "Carcinoma, Transitional Cell;Urologic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Padcev, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.  Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma Europe B.V.", "european_commission_decision_date": "17/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/04/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "05/05/2022", "last_updated_date": "25/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/padcev" }, { "category": "Human", "name_of_medicine": "ProQuad", "ema_product_number": "EMEA/H/C/000622", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000300468", "international_non_proprietary_name_common_name": "measles, mumps, rubella and varicella vaccine (live)", "active_substance": "virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella", "therapeutic_area_mesh": "Chickenpox;Rubella;Measles;Mumps;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BD54", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age. ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "24/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/04/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "18/05/2017", "last_updated_date": "25/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/proquad" }, { "category": "Human", "name_of_medicine": "Riulvy", "ema_product_number": "EMEA/H/C/006427", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000296641", "international_non_proprietary_name_common_name": "tegomil fumarate", "active_substance": "tegomil fumarate", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Riulvy is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Neuraxpharm Pharmaceuticals S.L.", "european_commission_decision_date": "23/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/07/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "23/05/2025", "last_updated_date": "25/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/riulvy" }, { "category": "Human", "name_of_medicine": "Vaxchora", "ema_product_number": "EMEA/H/C/003876", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282352", "international_non_proprietary_name_common_name": "cholera vaccine, oral, live", "active_substance": "vibrio cholerae, strain cvd 103-hgr, live", "therapeutic_area_mesh": "Cholera", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AE02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vaxchora is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older. This vaccine should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bavarian Nordic A/S", "european_commission_decision_date": "23/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/04/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "08/04/2020", "last_updated_date": "24/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vaxchora" }, { "category": "Human", "name_of_medicine": "Olanzapine Apotex", "ema_product_number": "EMEA/H/C/001178", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0048", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Apotex Europe BV", "european_commission_decision_date": "08/03/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/06/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "12/08/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "07/02/2017", "last_updated_date": "23/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/olanzapine-apotex" }, { "category": "Human", "name_of_medicine": "Ordspono", "ema_product_number": "EMEA/H/C/006215", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000254850", "international_non_proprietary_name_common_name": "odronextamab", "active_substance": "odronextamab", "therapeutic_area_mesh": "Lymphoma, Follicular", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "Not yet assigned", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy. Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after two or more lines of systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Regeneron Ireland Designated Activity Company (DAC)", "european_commission_decision_date": "23/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "28/06/2024", "last_updated_date": "19/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ordspono" }, { "category": "Human", "name_of_medicine": "Trixeo Aerosphere", "ema_product_number": "EMEA/H/C/004983", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "C/WS2780", "international_non_proprietary_name_common_name": "formoterol;glycopyrronium bromide;budesonide", "active_substance": "formoterol fumarate dihydrate;glycopyrronium bromide;Budesonide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "24/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/10/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "05/01/2021", "last_updated_date": "19/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trixeo-aerosphere" }, { "category": "Human", "name_of_medicine": "Zonegran", "ema_product_number": "EMEA/H/C/000577", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000295722", "international_non_proprietary_name_common_name": "zonisamide", "active_substance": "zonisamide", "therapeutic_area_mesh": "Epilepsies, Partial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zonegran is indicated as: monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged six years and above.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amdipharm Limited", "european_commission_decision_date": "17/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2004", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/03/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "08/01/2018", "last_updated_date": "18/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zonegran" }, { "category": "Human", "name_of_medicine": "Ogluo", "ema_product_number": "EMEA/H/C/005391", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000290390", "international_non_proprietary_name_common_name": "glucagon", "active_substance": "Glucagon", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H04AA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pancreatic hormones;Glycogenolytic hormones", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Strongbridge Dublin Limited", "european_commission_decision_date": "15/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "26/02/2021", "last_updated_date": "17/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ogluo" }, { "category": "Human", "name_of_medicine": "Viagra", "ema_product_number": "EMEA/H/C/000202", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000296269", "international_non_proprietary_name_common_name": "sildenafil", "active_substance": "sildenafil", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Viagra to be effective, sexual stimulation is required.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Upjohn EESV", "european_commission_decision_date": "15/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/05/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/09/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "51", "first_published_date": "17/06/2016", "last_updated_date": "17/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/viagra" }, { "category": "Human", "name_of_medicine": "Revatio", "ema_product_number": "EMEA/H/C/000638", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000296239", "international_non_proprietary_name_common_name": "sildenafil", "active_substance": "sildenafil", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with pulmonary arterial hypertension classified as World Health Organization (WHO) functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment of paediatric patients aged one year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease. Revatio solution for injection is for the treatment of adult patients with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable. Revatio (oral) is indicated for treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Upjohn EESV", "european_commission_decision_date": "15/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/07/2005", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/10/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "54", "first_published_date": "30/07/2018", "last_updated_date": "17/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/revatio" }, { "category": "Human", "name_of_medicine": "Bomyntra", "ema_product_number": "EMEA/H/C/006269", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Neoplasms, Bone Tissue;Giant Cell Tumor of Bone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "17/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/07/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/05/2025", "last_updated_date": "17/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bomyntra" }, { "category": "Human", "name_of_medicine": "Mylotarg", "ema_product_number": "EMEA/H/C/004204", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000278463", "international_non_proprietary_name_common_name": "gemtuzumab ozogamicin", "active_substance": "gemtuzumab ozogamicin", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "11/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "30/07/2018", "last_updated_date": "17/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mylotarg" }, { "category": "Human", "name_of_medicine": "Baqsimi", "ema_product_number": "EMEA/H/C/003848", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000244909", "international_non_proprietary_name_common_name": "glucagon", "active_substance": "Glucagon", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H04AA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pancreatic hormones;Glycogenolytic hormones", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amphastar France Pharmaceuticals", "european_commission_decision_date": "22/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/12/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "06/02/2020", "last_updated_date": "15/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/baqsimi" }, { "category": "Human", "name_of_medicine": "Emselex", "ema_product_number": "EMEA/H/C/000554", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000248469", "international_non_proprietary_name_common_name": "darifenacin hydrobromide", "active_substance": "darifenacin hydrobromide", "therapeutic_area_mesh": "Urinary Incontinence, Urge;Urinary Bladder, Overactive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BD10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals;Drugs for urinary frequency and incontinence", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "pharmaand GmbH", "european_commission_decision_date": "14/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/07/2004", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/10/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "15/02/2018", "last_updated_date": "15/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emselex" }, { "category": "Human", "name_of_medicine": "Thalidomide Lipomed", "ema_product_number": "EMEA/H/C/005715", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0003", "international_non_proprietary_name_common_name": "thalidomide", "active_substance": "thalidomide", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ? 65 years or ineligible for high dose chemotherapy. Thalidomide Lipomed is prescribed and dispensed in accordance with the Thalidomide Lipomed Pregnancy Prevention Programme (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lipomed GmbH", "european_commission_decision_date": "10/05/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "18/07/2022", "last_updated_date": "15/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/thalidomide-lipomed" }, { "category": "Human", "name_of_medicine": "Locametz", "ema_product_number": "EMEA/H/C/005488", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000261049", "international_non_proprietary_name_common_name": "gozetotide", "active_substance": "gozetotide", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09I", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high risk PCa prior to primary curative therapy, Suspected PCa recurrence in patients with increasing levels of serum prostate specific antigen (PSA) after primary curative therapy, Identification of patients with PSMA positive progressive metastatic castration resistant prostate cancer (mCRPC) for whom PSMA targeted therapy is indicated (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "31/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "21/12/2022", "last_updated_date": "15/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/locametz" }, { "category": "Human", "name_of_medicine": "Velsipity", "ema_product_number": "EMEA/H/C/006007", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000293340", "international_non_proprietary_name_common_name": "etrasimod", "active_substance": "Etrasimod arginine", "therapeutic_area_mesh": "Colitis, Ulcerative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AE05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Velsipity is indicated for the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "11/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/02/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "21/02/2024", "last_updated_date": "12/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/velsipity" }, { "category": "Human", "name_of_medicine": "Axitinib Accord", "ema_product_number": "EMEA/H/C/006206", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000293302", "international_non_proprietary_name_common_name": "axitinib", "active_substance": "axitinib", "therapeutic_area_mesh": "Carcinoma, Renal Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EK01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Axitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "08/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "26/07/2024", "last_updated_date": "11/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/axitinib-accord" }, { "category": "Human", "name_of_medicine": "Champix", "ema_product_number": "EMEA/H/C/000699", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000294872", "international_non_proprietary_name_common_name": "varenicline", "active_substance": "varenicline", "therapeutic_area_mesh": "Tobacco Use Cessation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07BA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Champix is indicated for smoking cessation in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "10/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/09/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "30/07/2018", "last_updated_date": "11/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/champix" }, { "category": "Human", "name_of_medicine": "Nilotinib Accord", "ema_product_number": "EMEA/H/C/006315", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000291910", "international_non_proprietary_name_common_name": "nilotinib", "active_substance": "nilotinib", "therapeutic_area_mesh": "Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "26/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "28/06/2024", "last_updated_date": "11/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nilotinib-accord" }, { "category": "Human", "name_of_medicine": "Rukobia", "ema_product_number": "EMEA/H/C/005011", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000264656", "international_non_proprietary_name_common_name": "fostemsavir", "active_substance": "fostemsavir trometamol", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare B.V.", "european_commission_decision_date": "08/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "12/02/2021", "last_updated_date": "11/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rukobia" }, { "category": "Human", "name_of_medicine": "Ryjunea", "ema_product_number": "EMEA/H/C/006324", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "atropine sulfate", "active_substance": "atropine sulfate", "therapeutic_area_mesh": "Myopia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01FA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ryjunea is indicated for slowing the progression of myopia in paediatric patients. Treatment may be initiated in children aged 3-14 years with a progression rate of 0.5 D or more per year and a severity of -0.5 D to -6.0 D.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Santen Oy", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/03/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/03/2025", "last_updated_date": "11/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ryjunea" }, { "category": "Human", "name_of_medicine": "Spravato", "ema_product_number": "EMEA/H/C/004535", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010825/202403", "international_non_proprietary_name_common_name": "esketamine", "active_substance": "esketamine hydrochloride", "therapeutic_area_mesh": "Depressive Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antidepressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "12/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/12/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "19/12/2019", "last_updated_date": "10/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/spravato" }, { "category": "Human", "name_of_medicine": "Hemlibra", "ema_product_number": "EMEA/H/C/004406", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000245115", "international_non_proprietary_name_common_name": "emicizumab", "active_substance": "emicizumab", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency): with factor VIII inhibitors without factor VIII inhibitors who have: severe disease (FVIII < 1%) moderate disease (FVIII ? 1% and ? 5%) with severe bleeding phenotype. Hemlibra can be used in all age groups.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration Limited", "european_commission_decision_date": "27/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/01/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/02/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "23/08/2018", "last_updated_date": "10/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hemlibra" }, { "category": "Human", "name_of_medicine": "Tasmar", "ema_product_number": "EMEA/H/C/000132", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000294075", "international_non_proprietary_name_common_name": "tolcapone", "active_substance": "tolcapone", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs;Other dopaminergic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tasmar is indicated in combination with levodopa / benserazide or levodopa / carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-O-methyltransferase (COMT) inhibitors. Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa / benserazide or levodopa / carbidopa. Since Tasmar should be used only in combination with levodopa / benserazide and levodopa / carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Healthcare Limited", "european_commission_decision_date": "08/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/08/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "08/08/2018", "last_updated_date": "10/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tasmar" }, { "category": "Human", "name_of_medicine": "Zinforo", "ema_product_number": "EMEA/H/C/002252", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUR/0000248505", "international_non_proprietary_name_common_name": "ceftaroline fosamil", "active_substance": "ceftaroline fosamil", "therapeutic_area_mesh": "Community-Acquired Infections;Skin Diseases, Infectious;Pneumonia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01DI02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults: Complicated skin and soft tissue infections (cSSTI) Community-acquired pneumonia (CAP) Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Ireland Pharmaceuticals", "european_commission_decision_date": "14/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/06/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "21/12/2017", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zinforo" }, { "category": "Human", "name_of_medicine": "Revlimid", "ema_product_number": "EMEA/H/C/000717", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0130", "international_non_proprietary_name_common_name": "lenalidomide", "active_substance": "lenalidomide", "therapeutic_area_mesh": "Multiple Myeloma;Lymphoma, Mantle-Cell;Myelodysplastic Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Multiple myeloma Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromes Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Mantle cell lymphoma Revlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. Follicular lymphoma Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "05/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/06/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "54", "first_published_date": "29/06/2018", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/revlimid" }, { "category": "Human", "name_of_medicine": "Ecalta", "ema_product_number": "EMEA/H/C/000788", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282338", "international_non_proprietary_name_common_name": "anidulafungin", "active_substance": "anidulafungin", "therapeutic_area_mesh": "Candidiasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "09/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "28/08/2017", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ecalta" }, { "category": "Veterinary", "name_of_medicine": "Equisolon", "ema_product_number": "EMEA/V/C/002382", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Prednisolone", "active_substance": "prednisolone", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Corticosteroids for systemic use, plain;prednisolone;Systemic hormonal preparations, excl. sex hormones and insulin", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/10/2016", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/equisolon" }, { "category": "Veterinary", "name_of_medicine": "Equioxx", "ema_product_number": "EMEA/V/C/000142", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "firocoxib", "active_substance": "firocoxib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products, non-steroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/06/2017", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/equioxx" }, { "category": "Veterinary", "name_of_medicine": "Equilis West Nile", "ema_product_number": "EMEA/V/C/002241", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated chimaeric flavivirus strain YF-WN", "active_substance": "inactivated chimaeric flavivirus strain YF-WN", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/04/2018", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/equilis-west-nile" }, { "category": "Veterinary", "name_of_medicine": "Fungitraxx", "ema_product_number": "EMEA/V/C/002722", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "itraconazole", "active_substance": "Itraconazole", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antimycotics for systemic use;Triazole derivatives;itraconazole", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/05/2016", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/fungitraxx" }, { "category": "Veterinary", "name_of_medicine": "Fortekor Plus", "ema_product_number": "EMEA/V/C/002804", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "benazepril;pimobendan", "active_substance": "benazepril hydrochloride;pimobendan", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "ACE inhibitors, combinations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "07/06/2016", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/fortekor-plus" }, { "category": "Veterinary", "name_of_medicine": "Felpreva", "ema_product_number": "EMEA/V/C/005464", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "emodepside;praziquantel;tigolaner", "active_substance": "emodepside;praziquantel;tigolaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anthelmintics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/09/2021", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/felpreva" }, { "category": "Veterinary", "name_of_medicine": "Fatrovax RHD", "ema_product_number": "EMEA/V/C/005301", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rabbit haemorrhagic disease vaccine (inactivated, recombinant)", "active_substance": "rabbit hemorrhagic disease virus 2 VP1AB;rabbit hemorrhagic disease virus VP1A", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for leporidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/06/2021", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/fatrovax-rhd" }, { "category": "Veterinary", "name_of_medicine": "Evant", "ema_product_number": "EMEA/V/C/004902", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "coccidiosis vaccine live for chickens", "active_substance": "Eimeria maxima, strain 013;Eimeria mitis, strain 006;Eimeria praecox, strain 007;Eimeria tenella, strain 004", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live parasitic vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/03/2019", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/evant" }, { "category": "Veterinary", "name_of_medicine": "Evalon", "ema_product_number": "EMEA/V/C/004013", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Eimeria acervulina, strain 003;Eimeria brunetti, strain 034;Eimeria maxima, strain 013;Eimeria necatrix, strain 033;Eimeria tenella, strain 004", "active_substance": "vaccine against coccidiosis in chickens", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Live parasitic vaccines;Immunologicals for aves", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/06/2017", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/evalon" }, { "category": "Veterinary", "name_of_medicine": "Eurican Herpes 205", "ema_product_number": "EMEA/V/C/000059", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "canine herpes vaccine (inactivated subunit)", "active_substance": "Canine herpesvirus (F205 strain) antigens", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for canidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/09/2015", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/eurican-herpes-205" }, { "category": "Veterinary", "name_of_medicine": "Eryseng", "ema_product_number": "EMEA/V/C/002761", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Erysipelothrix rhusiopathiae", "active_substance": "Erysipelothrix rhusiopathiae, strain R32E11 (inactivated)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/06/2017", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/eryseng" }, { "category": "Veterinary", "name_of_medicine": "Eryseng Parvo", "ema_product_number": "EMEA/V/C/002762", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "porcine parvovirus and Erysipelothrix rhusiopathiae", "active_substance": "porcine parvovirus, strain NADL-2 and Erysipelothrix rhusiopathiae, strain R32E11 (inactivated)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated viral and inactivated bacterial vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/06/2017", "last_updated_date": "09/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/eryseng-parvo" }, { "category": "Human", "name_of_medicine": "Eksunbi", "ema_product_number": "EMEA/H/C/006448", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000267789", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Crohn Disease;Colitis, Ulcerative;Psoriasis;Arthritis, Psoriatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Crohn’s DiseaseEksunbi is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.Ulcerative colitisEksunbi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies (see section 5.1).Plaque psoriasisEksunbi is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).Paediatric plaque psoriasisEksunbi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).Psoriatic arthritis (PsA)Eksunbi, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "23/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "19/08/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "26/07/2024", "last_updated_date": "08/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eksunbi" }, { "category": "Human", "name_of_medicine": "Yaxwer", "ema_product_number": "EMEA/H/C/006437", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Neoplasms, Bone Tissue;Giant Cell Tumor of Bone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/06/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/04/2025", "last_updated_date": "08/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yaxwer" }, { "category": "Veterinary", "name_of_medicine": "Equilis StrepE", "ema_product_number": "EMEA/V/C/000078", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "live vaccine against Streptococcus equi", "active_substance": "live deletion-mutant Streptococcus equi strain TW928", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for equidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/04/2014", "last_updated_date": "05/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/equilis-strepe" }, { "category": "Veterinary", "name_of_medicine": "Enteroporc Coli AC", "ema_product_number": "EMEA/V/C/005149", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "neonatal piglet colibacillosis (recombinant, inactivated);Clostridium perfringens vaccine (inactivated)", "active_substance": "inactivated fimbrial adhesins of Escherichia coli;clostridium perfringens type A/C toxoids", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/08/2021", "last_updated_date": "05/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/enteroporc-coli-ac" }, { "category": "Veterinary", "name_of_medicine": "Emdocam", "ema_product_number": "EMEA/V/C/002283", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Oxicams", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/06/2016", "last_updated_date": "05/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/emdocam" }, { "category": "Veterinary", "name_of_medicine": "Econor", "ema_product_number": "EMEA/V/C/000042", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "valnemulin", "active_substance": "valnemulin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/07/2017", "last_updated_date": "05/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/econor" }, { "category": "Veterinary", "name_of_medicine": "Easotic", "ema_product_number": "EMEA/V/C/000140", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1409/G", "international_non_proprietary_name_common_name": "hydrocortisone aceponate;miconazole nitrate;gentamicin sulfate", "active_substance": "gentamicin sulfate;hydrocortisone aceponate;miconazole nitrate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Otologicals;Corticosteroids and antiinfectives in combination", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/10/2017", "last_updated_date": "04/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/easotic" }, { "category": "Veterinary", "name_of_medicine": "Draxxin", "ema_product_number": "EMEA/V/C/000077", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tulathromycin", "active_substance": "tulathromycin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/10/2017", "last_updated_date": "04/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/draxxin" }, { "category": "Veterinary", "name_of_medicine": "Cortavance", "ema_product_number": "EMEA/V/C/000110", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "hydrocortisone aceponate", "active_substance": "hydrocortisone aceponate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Corticosteroids, dermatological preparations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/05/2018", "last_updated_date": "04/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cortavance" }, { "category": "Veterinary", "name_of_medicine": "Contacera", "ema_product_number": "EMEA/V/C/002612", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products, non-steroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/11/2017", "last_updated_date": "04/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/contacera" }, { "category": "Veterinary", "name_of_medicine": "Coliprotec F4/F18", "ema_product_number": "EMEA/V/C/004225", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "porcine post-weaning diarrhoea vaccine (live)", "active_substance": "Live non-pathogenic Escherichia coli O141:K94 (F18ac) and O8:K87 (F4ac)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Live bacterial vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "03/05/2017", "last_updated_date": "04/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/coliprotec-f4-f18" }, { "category": "Veterinary", "name_of_medicine": "Clynav", "ema_product_number": "EMEA/V/C/002390", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "salmon pancreas disease vaccine (recombinant DNA plasmid)", "active_substance": "pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Atlantic salmon", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/08/2018", "last_updated_date": "04/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/clynav" }, { "category": "Veterinary", "name_of_medicine": "Clomicalm", "ema_product_number": "EMEA/V/C/000039", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "clomipramine", "active_substance": "clomipramine hydrochloride", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Psychoanaleptics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/04/2016", "last_updated_date": "04/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/clomicalm" }, { "category": "Human", "name_of_medicine": "Eurartesim", "ema_product_number": "EMEA/H/C/001199", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000295016", "international_non_proprietary_name_common_name": "piperaquine tetraphosphate;artenimol", "active_substance": "piperaquine tetraphosphate;artenimol", "therapeutic_area_mesh": "Malaria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "P01BF05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiprotozoals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, children and infants 6 months and over and weighing 5 kg or more. Consideration should be given to official guidance on the appropriate use of antimalarial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Alfasigma S.p.A.", "european_commission_decision_date": "03/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/10/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "14/09/2017", "last_updated_date": "04/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eurartesim" }, { "category": "Veterinary", "name_of_medicine": "Clevor", "ema_product_number": "EMEA/V/C/004417", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ropinirole", "active_substance": "ropinirole hydrochloride", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Dopaminergic agents;Dopamine agonists", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/04/2018", "last_updated_date": "03/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/clevor" }, { "category": "Veterinary", "name_of_medicine": "Chanhold", "ema_product_number": "EMEA/V/C/004824", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "selamectin", "active_substance": "selamectin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/05/2019", "last_updated_date": "03/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/chanhold" }, { "category": "Veterinary", "name_of_medicine": "Baycox Iron", "ema_product_number": "EMEA/V/C/004794", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "toltrazuril;iron (III) ion", "active_substance": "Iron(iii) ion;toltrazuril", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiprotozoals", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/06/2019", "last_updated_date": "03/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/baycox-iron" }, { "category": "Human", "name_of_medicine": "Lokelma", "ema_product_number": "EMEA/H/C/004029", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000261570", "international_non_proprietary_name_common_name": "sodium zirconium cyclosilicate", "active_substance": "sodium zirconium cyclosilicate", "therapeutic_area_mesh": "Hyperkalemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AE10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lokelma is indicated for the treatment of hyperkalaemia in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "24/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/01/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/03/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "27/04/2018", "last_updated_date": "03/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lokelma" }, { "category": "Human", "name_of_medicine": "Ebilfumin", "ema_product_number": "EMEA/H/C/003717", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000292533", "international_non_proprietary_name_common_name": "oseltamivir", "active_substance": "oseltamivir", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AH02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use;Neuraminidase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of influenzaIn patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Ebilfumin is indicated for the treatment of infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child. Prevention of influenzaPost-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. The appropriate use of Ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older. Ebilfumin is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). Ebilfumin is not a substitute for influenza vaccination.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "01/09/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/03/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/05/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "29/05/2018", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ebilfumin" }, { "category": "Veterinary", "name_of_medicine": "Syvazul BTV", "ema_product_number": "EMEA/V/C/004611", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)", "active_substance": "Inactivated bluetongue virus, serotype 1, strain ALG2006/01 E1;Inactivated bluetongue virus, serotype 4, strain BTV-4/SPA-1/2004;Inactivated bluetongue virus, serotype 8, strain BEL2006/01", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Ovidae;Immunologicals for Bovidae;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/11/2018", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/syvazul-btv" }, { "category": "Veterinary", "name_of_medicine": "Syvazul BTV 3", "ema_product_number": "EMEA/V/C/006623", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bluetongue virus vaccine (inactivated)", "active_substance": "bluetongue virus, serotype 3, BTV-3/NET2023, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Ovidae;Immunologicals for Bovidae;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/01/2025", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/syvazul-btv-3" }, { "category": "Veterinary", "name_of_medicine": "Daxocox", "ema_product_number": "EMEA/V/C/005354", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "enflicoxib", "active_substance": "enflicoxib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/07/2021", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/daxocox" }, { "category": "Veterinary", "name_of_medicine": "Nobivac LeuFel", "ema_product_number": "EMEA/V/C/004778", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "feline leukaemia vaccine (inactivated)", "active_substance": "purified Rp-45 FeLV-envelope antigen", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/11/2017", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobivac-leufel" }, { "category": "Veterinary", "name_of_medicine": "Nobivac Myxo-RHD Plus", "ema_product_number": "EMEA/V/C/004989", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "myxomatosis and rabbit haemorrhagic viral disease vaccine (live recombinant)", "active_substance": "Live myxoma vectored RHD virus strain 009;Live myxoma vectored RHD virus strain MK1899", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for leporidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/12/2019", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobivac-myxo-rhd-plus" }, { "category": "Veterinary", "name_of_medicine": "Leucogen", "ema_product_number": "EMEA/V/C/000144", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "feline leukaemia vaccine (inactivated)", "active_substance": "purified p45 FeLV-envelope antigen", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for felidae;Inactivated viral vaccines;feline leukaemia virus", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/12/2016", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/leucogen" }, { "category": "Veterinary", "name_of_medicine": "Eravac", "ema_product_number": "EMEA/V/C/004239", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rabbit haemorrhagic disease vaccine (inactivated)", "active_substance": "inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strainV-1037", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/03/2018", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/eravac" }, { "category": "Veterinary", "name_of_medicine": "Startvac", "ema_product_number": "EMEA/V/C/000130", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "adjuvanted inactivated vaccine for cattle against Staphylococcus aureus, coliforms and coagulase-negative staphylococci", "active_substance": "Escherichia coli J5 inactivated;staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime-associated antigenic complex", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "02/03/2018", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/startvac" }, { "category": "Veterinary", "name_of_medicine": "Suvaxyn CSF Marker", "ema_product_number": "EMEA/V/C/002757", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "classical swine fever vaccine (live recombinant)", "active_substance": "Live Recombinant E2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus E2 gene (CP7_E2alf)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Live viral vaccines;Immunologicals for suidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/suvaxyn-csf-marker" }, { "category": "Veterinary", "name_of_medicine": "NexGard", "ema_product_number": "EMEA/V/C/002729", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "afoxolaner", "active_substance": "afoxolaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Isoxazolines;Ectoparasiticides for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/07/2018", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nexgard" }, { "category": "Veterinary", "name_of_medicine": "Nexgard Spectra", "ema_product_number": "EMEA/V/C/003842", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "afoxolaner;milbemycin oxime", "active_substance": "afoxolaner;milbemycin oxime", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Endectocides;Antiparasitic products, insecticides and repellents;milbemycin oxime, combinations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/11/2017", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nexgard-spectra" }, { "category": "Veterinary", "name_of_medicine": "Fluralaner Intervet", "ema_product_number": "EMEA/V/C/006356", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fluralaner", "active_substance": "fluralaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QP53BE02", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for systemic use;Isoxazolines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/05/2025", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/fluralaner-intervet" }, { "category": "Veterinary", "name_of_medicine": "Innovax-ND-IBD-ILT", "ema_product_number": "EMEA/V/C/006442", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian infectious laryngotracheitis;infectious bursal disease;Marek's disease vaccine (live recombinant);Newcastle disease virus vaccine (inactivated)", "active_substance": "turkey herpesvirus strain HVT/ND/IBD/ILT (cell-associated), expressing the fusion protein gene of Newcastle disease virus, the VP2 protein gene of infectious bursal disease virus and the glycoproteins gD and gI genes of infectious laryngotracheitis virus, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Live viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/05/2025", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/innovax-nd-ibd-ilt" }, { "category": "Veterinary", "name_of_medicine": "Nobilis Multriva Gm+REOm", "ema_product_number": "EMEA/V/C/006614", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian infectious bursal disease;avian reovirus vaccine (inactivated)", "active_substance": "inactivated avian reovirus strain ARV-1;inactivated avian reovirus strain ARV-4;inactivated infectious bursal disease virus, strain 89/03;Inactivated infectious bursal disease virus, strain GB02", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/04/2025", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-multriva-gmreom" }, { "category": "Veterinary", "name_of_medicine": "Nobilis Multriva IBm+ND", "ema_product_number": "EMEA/V/C/006589", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian infectious bronchitis virus;Newcastle disease virus vaccine (inactivated)", "active_substance": "inactivated avian infectious bronchitis virus, type Massachusetts, strain M41;inactivated avian infectious bronchitis virus, type 793/B, strain 4-91;Newcastle disease virus, strain Ulster, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/04/2025", "last_updated_date": "02/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-multriva-ibmnd" }, { "category": "Veterinary", "name_of_medicine": "Bravecto CombiUNO", "ema_product_number": "EMEA/V/C/006358", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fluralaner;milbemycin oxime", "active_substance": "fluralaner;milbemycin oxime", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents;Endectocides;Milbemycins;moxidectin, combinations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/06/2025", "last_updated_date": "01/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bravecto-combiuno" }, { "category": "Veterinary", "name_of_medicine": "Zenrelia", "ema_product_number": "EMEA/V/C/006332", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ilunocitinib", "active_substance": "ilunocitinib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Dermatologicals;Agents for dermatitis, excluding corticosteroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/06/2025", "last_updated_date": "01/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zenrelia" }, { "category": "Veterinary", "name_of_medicine": "Numelvi", "ema_product_number": "EMEA/V/C/006480", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "atinvicitinib", "active_substance": "atinvicitinib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Dermatologicals;Agents for dermatitis, excluding corticosteroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/06/2025", "last_updated_date": "01/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/numelvi" }, { "category": "Human", "name_of_medicine": "Jcovden (previously COVID-19 Vaccine Janssen)", "ema_product_number": "EMEA/H/C/005737", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0076", "international_non_proprietary_name_common_name": "COVID-19 vaccine (Ad26.COV2-S [recombinant])", "active_substance": "adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S)", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BN02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Jcovden is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "26/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/03/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "11/03/2021", "last_updated_date": "01/09/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jcovden" }, { "category": "Human", "name_of_medicine": "Nintedanib Accord", "ema_product_number": "EMEA/H/C/006179", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000286140", "international_non_proprietary_name_common_name": "nintedanib", "active_substance": "nintedanib", "therapeutic_area_mesh": "Idiopathic Pulmonary Fibrosis;Lung Diseases, Interstitial;Scleroderma, Systemic;Pulmonary Fibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section 5.1). Nintedanib Accord is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD). Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Accord is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs). Nintedanib Accord is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "29/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "23/02/2024", "last_updated_date": "29/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nintedanib-accord" }, { "category": "Human", "name_of_medicine": "Talzenna", "ema_product_number": "EMEA/H/C/004674", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "X/0022", "international_non_proprietary_name_common_name": "talazoparib", "active_substance": "talazoparib", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XK04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patient selection Breast cancer: Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method. Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable. Prostate cancer: There is no requirement for tumour mutation testing for selection of patients with mCRPC for treatment with Talzenna.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "19/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "08/07/2019", "last_updated_date": "29/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/talzenna" }, { "category": "Human", "name_of_medicine": "Nubeqa", "ema_product_number": "EMEA/H/C/004790", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000291956", "international_non_proprietary_name_common_name": "darolutamide", "active_substance": "darolutamide", "therapeutic_area_mesh": "Prostatic Neoplasms, Castration-Resistant", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "NUBEQA is indicated for the treatment of adult men with non‑metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "19/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/03/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "01/04/2020", "last_updated_date": "29/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nubeqa" }, { "category": "Human", "name_of_medicine": "Rivaroxaban Accord", "ema_product_number": "EMEA/H/C/005279", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0006", "international_non_proprietary_name_common_name": "rivaroxaban", "active_substance": "rivaroxaban", "therapeutic_area_mesh": "Acute Coronary Syndrome;Coronary Artery Disease;Peripheral Arterial Disease;Venous Thromboembolism;Stroke;Atrial Fibrillation;Pulmonary Embolism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AF01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients). Adults Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA) alone or with ASA plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1). Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "27/09/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/09/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/11/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "24/11/2020", "last_updated_date": "28/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rivaroxaban-accord" }, { "category": "Human", "name_of_medicine": "Zolgensma", "ema_product_number": "EMEA/H/C/004750", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000289527", "international_non_proprietary_name_common_name": "onasemnogene abeparvovec", "active_substance": "onasemnogene abeparvovec", "therapeutic_area_mesh": "Muscular Atrophy, Spinal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zolgensma is indicated for the treatment of: patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1, or patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "27/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/05/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "27/05/2020", "last_updated_date": "28/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zolgensma" }, { "category": "Human", "name_of_medicine": "Sarclisa", "ema_product_number": "EMEA/H/C/004977", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0035", "international_non_proprietary_name_common_name": "isatuximab", "active_substance": "Isatuximab", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC38", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sarclisa is indicated:  In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. In combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "18/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/05/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "12/06/2020", "last_updated_date": "28/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sarclisa" }, { "category": "Human", "name_of_medicine": "Tabrecta", "ema_product_number": "EMEA/H/C/004845", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000293181", "international_non_proprietary_name_common_name": "capmatinib", "active_substance": "capmatinib dihydrochloride monohydrate", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "26/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "13/04/2022", "last_updated_date": "27/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tabrecta" }, { "category": "Human", "name_of_medicine": "Laventair Ellipta (previously Laventair)", "ema_product_number": "EMEA/H/C/003754", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000282004", "international_non_proprietary_name_common_name": "umeclidinium bromide;vilanterol", "active_substance": "umeclidinium bromide;vilanterol", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Laventair Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "27/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/02/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/05/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "21/04/2017", "last_updated_date": "27/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/laventair-ellipta" }, { "category": "Human", "name_of_medicine": "Kyntheum", "ema_product_number": "EMEA/H/C/003959", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000292330", "international_non_proprietary_name_common_name": "brodalumab", "active_substance": "brodalumab", "therapeutic_area_mesh": "Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "LEO Pharma A/S", "european_commission_decision_date": "27/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "12/09/2017", "last_updated_date": "27/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kyntheum" }, { "category": "Human", "name_of_medicine": "Betmiga", "ema_product_number": "EMEA/H/C/002388", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249016", "international_non_proprietary_name_common_name": "mirabegron", "active_substance": "Mirabegron", "therapeutic_area_mesh": "Urinary Bladder, Overactive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BD12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Overactive bladder in adults  Betmiga prolonged-release tablets are indicated for symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.  Neurogenic detrusor overactivity in the paediatric population  Betmiga prolonged release tablets are indicated for treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 3 to less than 18 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma Europe B.V.", "european_commission_decision_date": "17/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/12/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "18/09/2017", "last_updated_date": "27/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/betmiga" }, { "category": "Human", "name_of_medicine": "Pregabalin Accord", "ema_product_number": "EMEA/H/C/004024", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000238644", "international_non_proprietary_name_common_name": "pregabalin", "active_substance": "pregabalin", "therapeutic_area_mesh": "Anxiety Disorders;Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Epilepsy Pregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "27/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/08/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "05/02/2018", "last_updated_date": "27/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pregabalin-accord" }, { "category": "Veterinary", "name_of_medicine": "Felisecto Plus", "ema_product_number": "EMEA/V/C/005093", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "selamectin;sarolaner", "active_substance": "selamectin;sarolaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/05/2019", "last_updated_date": "27/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/felisecto-plus" }, { "category": "Human", "name_of_medicine": "Iscover", "ema_product_number": "EMEA/H/C/000175", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000293175", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel", "therapeutic_area_mesh": "Stroke;Peripheral Vascular Diseases;Atrial Fibrillation;Myocardial Infarction;Acute Coronary Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)Clopidogrel in combination with ASA is indicated in: Adult patients with moderate to high-risk TIA (ABCD2  score ?4) or minor IS (NIHSS  ?3) within 24 hours of either the TIA or IS event. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "26/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/03/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/07/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "53", "first_published_date": "18/01/2018", "last_updated_date": "26/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/iscover" }, { "category": "Human", "name_of_medicine": "Dimethyl fumarate Accord", "ema_product_number": "EMEA/H/C/006471", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000292854", "international_non_proprietary_name_common_name": "dimethyl fumarate", "active_substance": "dimethyl fumarate", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare Ltd", "european_commission_decision_date": "25/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "11/07/2024", "last_updated_date": "26/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-accord" }, { "category": "Human", "name_of_medicine": "Galafold", "ema_product_number": "EMEA/H/C/004059", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000285583", "international_non_proprietary_name_common_name": "migalastat", "active_substance": "migalastat hydrochloride", "therapeutic_area_mesh": "Fabry Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "migalastat", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (?-galactosidase A deficiency) and who have an amenable mutation.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amicus Therapeutics Europe Limited", "european_commission_decision_date": "22/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/03/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/05/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "30/04/2018", "last_updated_date": "25/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/galafold" }, { "category": "Human", "name_of_medicine": "Vimkunya", "ema_product_number": "EMEA/H/C/005470", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Chikungunya vaccine (recombinant, adsorbed)", "active_substance": "Chikungunya virus (CHIKV) virus-like particle (VLP) proteins (capsid protein (C) and envelope proteins E1 and E2) derived from CHIKV Senegal strain 37997 produced in human embryonic kidney cells by recombinant DNA technology, adsorbed on aluminium hydroxide, hydrated", "therapeutic_area_mesh": "Chikungunya virus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vimkunya is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Bavarian Nordic A/S", "european_commission_decision_date": "28/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/03/2025", "last_updated_date": "22/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vimkunya" }, { "category": "Human", "name_of_medicine": "Ninlaro", "ema_product_number": "EMEA/H/C/003844", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010535/202311", "international_non_proprietary_name_common_name": "ixazomib", "active_substance": "ixazomib citrate", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ninlaro in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "16/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/11/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "17/09/2018", "last_updated_date": "21/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ninlaro" }, { "category": "Human", "name_of_medicine": "Trodelvy", "ema_product_number": "EMEA/H/C/005182", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0037", "international_non_proprietary_name_common_name": "sacituzumab govitecan", "active_substance": "sacituzumab govitecan", "therapeutic_area_mesh": "Breast Neoplasms;Triple Negative Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "05/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "24/11/2021", "last_updated_date": "21/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy" }, { "category": "Human", "name_of_medicine": "Fampyra", "ema_product_number": "EMEA/H/C/002097", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000280278", "international_non_proprietary_name_common_name": "fampridine", "active_substance": "Fampridine", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale 4-7).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merz Therapeutics GmbH", "european_commission_decision_date": "06/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/07/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "02/08/2018", "last_updated_date": "21/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fampyra" }, { "category": "Human", "name_of_medicine": "Esmya", "ema_product_number": "EMEA/H/C/002041", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A31/0049", "international_non_proprietary_name_common_name": "ulipristal", "active_substance": "ulipristal acetate", "therapeutic_area_mesh": "Leiomyoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03XB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ulipristal acetate is indicated for pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Ltd ", "european_commission_decision_date": "11/01/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/02/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/07/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "26/07/2018", "last_updated_date": "20/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/esmya" }, { "category": "Human", "name_of_medicine": "Raxone", "ema_product_number": "EMEA/H/C/003834", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000291989", "international_non_proprietary_name_common_name": "idebenone", "active_substance": "idebenone", "therapeutic_area_mesh": "Optic Atrophy, Hereditary, Leber", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06BX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics;Other psychostimulants and nootropics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A", "european_commission_decision_date": "19/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/09/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "08/03/2018", "last_updated_date": "20/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/raxone" }, { "category": "Human", "name_of_medicine": "Aucatzyl", "ema_product_number": "EMEA/H/C/005907", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "obecabtagene autoleucel", "active_substance": "obecabtagene autoleucel", "therapeutic_area_mesh": "Precursor B-Cell Lymphoblastic Leukemia-Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XL", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic leukaemia (B ALL).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Autolus GmbH", "european_commission_decision_date": "17/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/07/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/05/2025", "last_updated_date": "19/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aucatzyl" }, { "category": "Human", "name_of_medicine": "Fluenz Tetra", "ema_product_number": "EMEA/H/C/002617", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "EMEA/H/C/002617", "international_non_proprietary_name_common_name": "influenza vaccine (live attenuated, nasal)", "active_substance": "A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) / A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) / B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) / B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444)", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Influenza vaccines;Influenza, live attenuated", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. The use of Fluenz Tetra should be based on official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "14/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/12/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "14/07/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "28/08/2018", "last_updated_date": "14/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fluenz-tetra" }, { "category": "Human", "name_of_medicine": "Sixmo", "ema_product_number": "EMEA/H/C/004743", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000273813", "international_non_proprietary_name_common_name": "buprenorphine", "active_substance": "buprenorphine hydrochloride", "therapeutic_area_mesh": "Opioid-Related Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07BC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.", "european_commission_decision_date": "23/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/06/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "19/06/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "02/07/2019", "last_updated_date": "14/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sixmo" }, { "category": "Human", "name_of_medicine": "Amvuttra", "ema_product_number": "EMEA/H/C/005852", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0015", "international_non_proprietary_name_common_name": "vutrisiran", "active_substance": "vutrisiran sodium", "therapeutic_area_mesh": "Amyloid Neuropathies, Familial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Alnylam Netherlands B.V.", "european_commission_decision_date": "05/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "18/07/2022", "last_updated_date": "13/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amvuttra" }, { "category": "Human", "name_of_medicine": "Exparel liposomal", "ema_product_number": "EMEA/H/C/004586", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000248989", "international_non_proprietary_name_common_name": "bupivacaine", "active_substance": "bupivacaine", "therapeutic_area_mesh": "Acute Pain", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N01BB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Amides;Anesthetics, local", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Exparel liposomal is indicated: in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain. in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pacira Ireland Limited", "european_commission_decision_date": "23/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/09/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/11/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "10/12/2020", "last_updated_date": "13/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exparel-liposomal" }, { "category": "Human", "name_of_medicine": "Stribild", "ema_product_number": "EMEA/H/C/002574", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010082/202308", "international_non_proprietary_name_common_name": "elvitegravir;cobicistat;emtricitabine;tenofovir disoproxil", "active_substance": "elvitegravir;cobicistat;emtricitabine;tenofovir disoproxil fumarate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for treatment of HIV infections, combinations;Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV 1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "27/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/05/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "19/07/2018", "last_updated_date": "13/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/stribild" }, { "category": "Human", "name_of_medicine": "Wyost", "ema_product_number": "EMEA/H/C/006378", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000288202", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Giant Cell Tumor of Bone;Neoplasms, Bone Tissue", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.  Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "13/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/05/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "22/03/2024", "last_updated_date": "13/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/wyost" }, { "category": "Human", "name_of_medicine": "Instanyl", "ema_product_number": "EMEA/H/C/000959", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000291557", "international_non_proprietary_name_common_name": "fentanyl", "active_substance": "Fentanyl citrate", "therapeutic_area_mesh": "Pain;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02AB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.  Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Istituto Gentili S.r.l.", "european_commission_decision_date": "12/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "40", "first_published_date": "08/05/2018", "last_updated_date": "13/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/instanyl" }, { "category": "Human", "name_of_medicine": "Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau)", "ema_product_number": "EMEA/H/C/004061", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMEA/H/C/PSUSA/00010590/202410", "international_non_proprietary_name_common_name": "chenodeoxycholic acid", "active_substance": "chenodeoxycholic acid", "therapeutic_area_mesh": "Xanthomatosis, Cerebrotendinous;Metabolism, Inborn Errors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A05AA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bile and liver therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Leadiant GmbH", "european_commission_decision_date": "23/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/04/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "28/09/2017", "last_updated_date": "13/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/chenodeoxycholic-acid-leadiant" }, { "category": "Human", "name_of_medicine": "Enbrel", "ema_product_number": "EMEA/H/C/000262", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0255", "international_non_proprietary_name_common_name": "etanercept", "active_substance": "etanercept", "therapeutic_area_mesh": "Spondylitis, Ankylosing;Arthritis, Juvenile Rheumatoid;Arthritis, Psoriatic;Psoriasis;Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid-factor-positive or -negative) and extended oligoarthritis in children and adolescents from the age of two years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Enbrel has not been studied in children aged less than two years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis (AS) Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of six years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "10/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/11/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/02/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "76", "first_published_date": "03/05/2018", "last_updated_date": "13/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enbrel" }, { "category": "Human", "name_of_medicine": "Dyrupeg", "ema_product_number": "EMEA/H/C/006407", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000290486", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "Neutropenia;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CuraTeQ Biologics s.r.o", "european_commission_decision_date": "11/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/03/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "31/01/2025", "last_updated_date": "12/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dyrupeg-0" }, { "category": "Human", "name_of_medicine": "Targretin", "ema_product_number": "EMEA/H/C/000326", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000291441", "international_non_proprietary_name_common_name": "bexarotene", "active_substance": "bexarotene", "therapeutic_area_mesh": "Lymphoma, T-Cell, Cutaneous", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XF03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "H.A.C. Pharma", "european_commission_decision_date": "11/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/11/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/03/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "21/06/2018", "last_updated_date": "12/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/targretin" }, { "category": "Human", "name_of_medicine": "Naveruclif", "ema_product_number": "EMEA/H/C/006173", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000287045", "international_non_proprietary_name_common_name": "paclitaxel", "active_substance": "paclitaxel", "therapeutic_area_mesh": "Breast Neoplasms;Pancreatic Neoplasms;Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Naveruclif monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4). Naveruclif in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Naveruclif in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "11/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/01/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "27/02/2024", "last_updated_date": "12/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/naveruclif" }, { "category": "Human", "name_of_medicine": "Zometa", "ema_product_number": "EMEA/H/C/000336", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0103/G", "international_non_proprietary_name_common_name": "zoledronic acid", "active_substance": "zoledronic acid;zoledronic acid monohydrate", "therapeutic_area_mesh": "Cancer;Fractures, Bone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone; treatment of adult patients with tumour-induced hypercalcaemia (TIH).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Phoenix Labs Unlimited Company", "european_commission_decision_date": "05/09/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/03/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "40", "first_published_date": "13/07/2018", "last_updated_date": "11/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zometa" }, { "category": "Human", "name_of_medicine": "Cystadrops", "ema_product_number": "EMEA/H/C/003769", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0032", "international_non_proprietary_name_common_name": "mercaptamine", "active_substance": "mercaptamine hydrochloride", "therapeutic_area_mesh": "Cystinosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 6 months of age with cystinosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Rare Diseases", "european_commission_decision_date": "06/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/01/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "30/05/2018", "last_updated_date": "08/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cystadrops" }, { "category": "Human", "name_of_medicine": "Zebinix", "ema_product_number": "EMEA/H/C/000988", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000261032", "international_non_proprietary_name_common_name": "eslicarbazepine acetate", "active_substance": "eslicarbazepine acetate", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AF04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BIAL - Portela & Ca, S.A.", "european_commission_decision_date": "31/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/02/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/04/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "17/05/2018", "last_updated_date": "06/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zebinix" }, { "category": "Human", "name_of_medicine": "Riximyo", "ema_product_number": "EMEA/H/C/004729", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249103", "international_non_proprietary_name_common_name": "rituximab", "active_substance": "rituximab", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;Microscopic Polyangiitis;Wegener Granulomatosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Riximyo is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Riximyo is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy. Riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. Riximyo monotherapy is indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. Riximyo is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ? 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL). Chronic lymphocytic leukaemia (CLL) Riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy. See section 5.1 for further information. Rheumatoid arthritis Riximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. Rituximab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Granulomatosis with polyangiitis and microscopic polyangiitis Riximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). Riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ? 2 to < 18 years old) with severe, active GPA (Wegener’s) and MPA. Pemphigus vulgaris Riximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "10/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/04/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/06/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "14/10/2017", "last_updated_date": "05/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/riximyo" }, { "category": "Human", "name_of_medicine": "Omnitrope", "ema_product_number": "EMEA/H/C/000607", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000268066", "international_non_proprietary_name_common_name": "somatropin", "active_substance": "somatropin", "therapeutic_area_mesh": "Turner Syndrome;Prader-Willi Syndrome;Dwarfism, Pituitary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Infants, children and adolescents Growth disturbance due to insufficient secretion of growth hormone (GH). Growth disturbance associated with Turner syndrome. Growth disturbance associated with chronic renal insufficiency. Growth disturbance (current height standard-deviation score (SDS) < -2.5 and parental adjusted SDS < -1) in short children / adolescents born small for gestational age (SGA), with a birth weight and / or length below -2 standard deviations (SDs), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by four years of age or later. Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing. Adults Replacement therapy in adults with pronounced growth hormone deficiency. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. In patients with childhood-onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (SDS < -2) who may be considered for one test. The cut-off point of the dynamic test should be strict.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "05/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/06/2003", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/04/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "27/02/2018", "last_updated_date": "05/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/omnitrope" }, { "category": "Human", "name_of_medicine": "Docetaxel Kabi", "ema_product_number": "EMEA/H/C/002325", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282406", "international_non_proprietary_name_common_name": "docetaxel", "active_substance": "docetaxel", "therapeutic_area_mesh": "Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer. Docetaxel Kabi in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer. Gastric adenocarcinoma Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "04/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/03/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/05/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "02/07/2018", "last_updated_date": "04/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/docetaxel-kabi" }, { "category": "Human", "name_of_medicine": "Kalydeco", "ema_product_number": "EMEA/H/C/002494", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2551", "international_non_proprietary_name_common_name": "ivacaftor", "active_substance": "ivacaftor", "therapeutic_area_mesh": "Cystic Fibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R07AX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other respiratory system products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kalydeco tablets are indicated:  - As monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (Class III) mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. - In a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, and 3849+10kbC→T. - In a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (CF) who have at least one non-Class I mutation in the CFTR gene. Kalydeco granules are indicated: - As monotherapy for the treatment of infants aged at least 1 month, toddlers and children weighing 3 kg to less than 25 kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (Class III) mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. - In a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one non-Class I mutation in the CFTR gene.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vertex Pharmaceuticals (Ireland) Limited", "european_commission_decision_date": "04/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/05/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/07/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "46", "first_published_date": "08/09/2017", "last_updated_date": "04/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kalydeco" }, { "category": "Human", "name_of_medicine": "Rezolsta", "ema_product_number": "EMEA/H/C/002819", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "X/0054/G", "international_non_proprietary_name_common_name": "darunavir;cobicistat", "active_substance": "darunavir;cobicistat", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use;Antivirals for treatment of HIV infections, combinations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults and paediatric patients (aged 6years and older, weighing at least 25 kg).Genotypic testing should guide the use of Rezolsta.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.", "european_commission_decision_date": "18/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "29/06/2018", "last_updated_date": "04/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rezolsta" }, { "category": "Human", "name_of_medicine": "Bexsero", "ema_product_number": "EMEA/H/C/002333", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0123", "international_non_proprietary_name_common_name": "meningococcal group B Vaccine (rDNA, component, adsorbed)", "active_substance": "outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254);recombinant Neisseria meningitidis group B fHbp fusion protein;recombinant Neisseria meningitidis group B NadA protein;recombinant Neisseria meningitidis group B NHBA fusion protein", "therapeutic_area_mesh": "Meningitis, Meningococcal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AH09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Meningococcal vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunisation against invasive disease caused by Neisseria meningitidis serogroup-B strains.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GSK Vaccines S.r.l.", "european_commission_decision_date": "09/05/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/11/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/01/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "07/06/2018", "last_updated_date": "01/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bexsero" }, { "category": "Human", "name_of_medicine": "Enjaymo", "ema_product_number": "EMEA/H/C/005776", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000286918", "international_non_proprietary_name_common_name": "sutimlimab", "active_substance": "sutimlimab", "therapeutic_area_mesh": "Hemolysis;Anemia, Hemolytic, Autoimmune", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AJ04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (CAD).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Rare Diseases", "european_commission_decision_date": "01/08/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "14/09/2022", "last_updated_date": "01/08/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enjaymo" }, { "category": "Human", "name_of_medicine": "Saxenda", "ema_product_number": "EMEA/H/C/003780", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0042", "international_non_proprietary_name_common_name": "liraglutide", "active_substance": "liraglutide", "therapeutic_area_mesh": "Obesity;Overweight", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of • ≥ 30 kg/m² (obese), or• ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea. Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight. Adolescents (≥12 years) Saxenda can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with: obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points)* and body weight above 60 kg. Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *IOTF BMI cut-off points for obesity by sex between 12-18 years, in accordance with study design of the Trial 4180, see section 5.1. Children (6 to <12 years)Saxenda is indicated as an adjunct to healthy nutrition and increased physical activity for weight management in children from the age of 6 to <12 years with - obesity (BMI ≥95th percentile)* and- body weight ≥45 kgTreatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *CDC BMI cut-off points for obesity (≥95th percentile) by sex between 6 to <12 years, in accordance with study design of the Trial 4392, see section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "25/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/01/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/03/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "28/06/2018", "last_updated_date": "31/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda" }, { "category": "Human", "name_of_medicine": "Trepulmix", "ema_product_number": "EMEA/H/C/005207", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000284407", "international_non_proprietary_name_common_name": "treprostinil", "active_substance": "treprostinil sodium", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with WHO Functional Class (FC) III or IV and: inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or persistent or recurrent CTEPH after surgical treatment to improve exercise capacity.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SciPharm Sàrl", "european_commission_decision_date": "30/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/04/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "08/04/2020", "last_updated_date": "31/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trepulmix" }, { "category": "Human", "name_of_medicine": "Anoro Ellipta (previously Anoro)", "ema_product_number": "EMEA/H/C/002751", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000281782", "international_non_proprietary_name_common_name": "umeclidinium bromide;vilanterol", "active_substance": "umeclidinium bromide;vilanterol trifenatate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Anoro Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "28/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/02/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/05/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "13/07/2017", "last_updated_date": "31/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/anoro-ellipta" }, { "category": "Human", "name_of_medicine": "Sugammadex Piramal", "ema_product_number": "EMEA/H/C/006083", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000264648", "international_non_proprietary_name_common_name": "sugammadex", "active_substance": "sugammadex sodium", "therapeutic_area_mesh": "Neuromuscular Blockade", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AB35", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "sugammadex", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in paediatric patients from birth to 17 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Piramal Critical Care B.V.", "european_commission_decision_date": "06/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/06/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "24/04/2023", "last_updated_date": "31/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sugammadex-piramal" }, { "category": "Veterinary", "name_of_medicine": "Emevet", "ema_product_number": "EMEA/V/C/006439", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "maropitant", "active_substance": "Maropitant citrate monohydrate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Alimentary tract and metabolism;Other antiemetics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/04/2025", "last_updated_date": "30/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/emevet" }, { "category": "Human", "name_of_medicine": "Eklira Genuair", "ema_product_number": "EMEA/H/C/002211", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000288101", "international_non_proprietary_name_common_name": "aclidinium bromide", "active_substance": "aclidinium bromide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03BB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Covis Pharma Europe B.V.", "european_commission_decision_date": "29/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/07/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "18/05/2018", "last_updated_date": "29/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eklira-genuair" }, { "category": "Human", "name_of_medicine": "Duaklir Genuair", "ema_product_number": "EMEA/H/C/003745", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000288151", "international_non_proprietary_name_common_name": "aclidinium bromide;formoterol", "active_substance": "aclidinium bromide;formoterol fumarate dihydrate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Duaklir Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Covis Pharma Europe B.V.", "european_commission_decision_date": "29/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/09/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "18/05/2018", "last_updated_date": "29/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duaklir-genuair" }, { "category": "Human", "name_of_medicine": "Iqirvo", "ema_product_number": "EMEA/H/C/006231", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000285287", "international_non_proprietary_name_common_name": "elafibranor", "active_substance": "Elafibranor", "therapeutic_area_mesh": "Liver Cirrhosis, Biliary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A05AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bile and liver therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Iqirvo is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ipsen Pharma", "european_commission_decision_date": "28/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "26/07/2024", "last_updated_date": "28/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/iqirvo" }, { "category": "Human", "name_of_medicine": "Xofigo", "ema_product_number": "EMEA/H/C/002653", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000281776", "international_non_proprietary_name_common_name": "radium Ra223 dichloride", "active_substance": "radium (223Ra) dichloride", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V10XX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Therapeutic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "28/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/11/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "21/06/2018", "last_updated_date": "28/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xofigo" }, { "category": "Human", "name_of_medicine": "Vildagliptin / Metformin hydrochloride Accord", "ema_product_number": "EMEA/H/C/005738", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000287822", "international_non_proprietary_name_common_name": "vildagliptin;metformin hydrochloride", "active_substance": "metformin hydrochloride;vildagliptin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vildagliptin/Metformin hydrochloride Accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "25/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/03/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "14/12/2021", "last_updated_date": "25/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vildagliptin-metformin-hydrochloride-accord" }, { "category": "Human", "name_of_medicine": "Ifinwil", "ema_product_number": "EMEA/H/C/006067", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "eflornithine", "active_substance": "eflornithine hydrochloride monohydrate", "therapeutic_area_mesh": "Neuroblastoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX79", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of high-risk neuroblastoma responsive to prior multiagent, multimodality therapy ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Norgine B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "18/07/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/07/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ifinwil" }, { "category": "Human", "name_of_medicine": "Xoterna Breezhaler", "ema_product_number": "EMEA/H/C/003755", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000277818", "international_non_proprietary_name_common_name": "indacaterol;glycopyrronium bromide", "active_substance": "indacaterol;glycopyrronium bromide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "24/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "23/07/2018", "last_updated_date": "25/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xoterna-breezhaler" }, { "category": "Human", "name_of_medicine": "Ultibro Breezhaler", "ema_product_number": "EMEA/H/C/002679", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000276439", "international_non_proprietary_name_common_name": "indacaterol;glycopyrronium bromide", "active_substance": "indacaterol;glycopyrronium bromide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids;Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "24/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "23/07/2018", "last_updated_date": "25/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ultibro-breezhaler" }, { "category": "Human", "name_of_medicine": "Armisarte (previously Pemetrexed Actavis)", "ema_product_number": "EMEA/H/C/004109", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00002330/202402", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed diacid monohydrate", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Mesothelioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Malignant pleural mesothelioma Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "12/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/01/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "10/04/2018", "last_updated_date": "25/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/armisarte" }, { "category": "Human", "name_of_medicine": "Ulunar Breezhaler", "ema_product_number": "EMEA/H/C/003875", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000276348", "international_non_proprietary_name_common_name": "indacaterol;glycopyrronium bromide", "active_substance": "glycopyrronium bromide;indacaterol maleate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ulunar Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "24/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "08/05/2018", "last_updated_date": "25/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ulunar-breezhaler" }, { "category": "Human", "name_of_medicine": "Cresemba", "ema_product_number": "EMEA/H/C/002734", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010426/202409", "international_non_proprietary_name_common_name": "isavuconazole", "active_substance": "isavuconazole", "therapeutic_area_mesh": "Aspergillosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use;Triazole and triazole derivatives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Powder for concentrate for solution for infusion: Cresemba is indicated in patients from 1 year of age and older for the treatment of invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents. Hard capsules: Cresemba hard capsules are indicated in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents. Cresemba 40 mg hard capsules are intended to be used for paediatric patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Basilea Pharmaceutica Deutschland GmbH", "european_commission_decision_date": "17/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2005", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/10/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "24/08/2017", "last_updated_date": "24/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba" }, { "category": "Human", "name_of_medicine": "Amlodipine / Valsartan Mylan", "ema_product_number": "EMEA/H/C/004037", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000287321", "international_non_proprietary_name_common_name": "amlodipine;valsartan", "active_substance": "amlodipine besilate;valsartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "23/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/03/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "26/02/2018", "last_updated_date": "24/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amlodipine-valsartan-mylan" }, { "category": "Human", "name_of_medicine": "Supemtek Tetra (previously Supemtek)", "ema_product_number": "EMEA/H/C/005159", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000249010", "international_non_proprietary_name_common_name": "quadrivalent influenza vaccine (recombinant, prepared in cell culture)", "active_substance": "Influenza A virus subtype H1N1 haemagglutinin, recombinant;Influenza A virus subtype H3N2 haemagglutinin, recombinant;Influenza B virus Victoria lineage haemagglutinin, recombinant;Influenza B virus Yamagata lineage haemagglutinin, recombinant", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Supemtek Tetra is indicated for active immunization for the prevention of influenza disease in adults and children from 9 years of age and older. Supemtek Tetra should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "18/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/09/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/11/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "25/11/2020", "last_updated_date": "23/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/supemtek-tetra" }, { "category": "Human", "name_of_medicine": "Incruse Ellipta (previously Incruse)", "ema_product_number": "EMEA/H/C/002809", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000281876", "international_non_proprietary_name_common_name": "umeclidinium bromide", "active_substance": "umeclidinium bromide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03BB07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "17/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/02/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/04/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "13/07/2017", "last_updated_date": "22/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/incruse-ellipta" }, { "category": "Human", "name_of_medicine": "Lynozyfic", "ema_product_number": "EMEA/H/C/006370", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000273555", "international_non_proprietary_name_common_name": "linvoseltamab", "active_substance": "linvoseltamab", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Regeneron Ireland Designated Activity Company (DAC)", "european_commission_decision_date": "21/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/02/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "28/02/2025", "last_updated_date": "22/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lynozyfic" }, { "category": "Human", "name_of_medicine": "Zyclara", "ema_product_number": "EMEA/H/C/002387", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000286840", "international_non_proprietary_name_common_name": "imiquimod", "active_substance": "imiquimod", "therapeutic_area_mesh": "Keratosis;Keratosis, Actinic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D06BB10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibiotics and chemotherapeutics for dermatological use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Healthcare Limited", "european_commission_decision_date": "21/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/06/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "16/02/2018", "last_updated_date": "22/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zyclara" }, { "category": "Human", "name_of_medicine": "Fampridine Accord", "ema_product_number": "EMEA/H/C/005359", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000243787", "international_non_proprietary_name_common_name": "fampridine", "active_substance": "Fampridine", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fampridine Accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "23/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/09/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "02/10/2020", "last_updated_date": "18/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fampridine-accord" }, { "category": "Human", "name_of_medicine": "Aldara", "ema_product_number": "EMEA/H/C/000179", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000286628", "international_non_proprietary_name_common_name": "imiquimod", "active_substance": "imiquimod", "therapeutic_area_mesh": "Condylomata Acuminata;Keratosis;Keratosis, Actinic;Carcinoma, Basal Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D06BB10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibiotics and chemotherapeutics for dermatological use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imiquimod cream is indicated for the topical treatment of : External genital and perianal warts (condylomata acuminata) in adults. Small superficial basal cell carcinomas (sBCCs) in adults. Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Healthcare Limited", "european_commission_decision_date": "17/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/05/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "29/06/2018", "last_updated_date": "18/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aldara" }, { "category": "Human", "name_of_medicine": "Tolura", "ema_product_number": "EMEA/H/C/001196", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000279934", "international_non_proprietary_name_common_name": "telmisartan", "active_substance": "telmisartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Angiotensin II antagonists, plain", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease or peripheral arterial disease) or; type 2 diabetes mellitus with documented target organ damage.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto ", "european_commission_decision_date": "17/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/03/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/06/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "19/02/2018", "last_updated_date": "18/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tolura" }, { "category": "Veterinary", "name_of_medicine": "Cevac Reomune", "ema_product_number": "EMEA/V/C/006142", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian reovirus vaccine (inactivated)", "active_substance": "avian reovirus, strain S1133, inactivated;avian reovirus, strain 11-12523, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/07/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cevac-reomune" }, { "category": "Human", "name_of_medicine": "Nordimet", "ema_product_number": "EMEA/H/C/003983", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282579", "international_non_proprietary_name_common_name": "methotrexate", "active_substance": "methotrexate", "therapeutic_area_mesh": "Arthritis, Psoriatic;Psoriasis;Arthritis, Juvenile Rheumatoid;Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nordimet is indicated for the treatment of: active rheumatoid arthritis in adult patients, polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate, moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients,  induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Nordic Group B.V.", "european_commission_decision_date": "15/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "16/05/2018", "last_updated_date": "17/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nordimet" }, { "category": "Human", "name_of_medicine": "Nimvastid", "ema_product_number": "EMEA/H/C/001029", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000284684", "international_non_proprietary_name_common_name": "rivastigmine", "active_substance": "rivastigmine", "therapeutic_area_mesh": "Dementia;Alzheimer Disease;Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "15/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/05/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "18/01/2018", "last_updated_date": "17/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nimvastid" }, { "category": "Human", "name_of_medicine": "Ivabradine Zentiva", "ema_product_number": "EMEA/H/C/004117", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000284827", "international_non_proprietary_name_common_name": "ivabradine", "active_substance": "ivabradine hydrochloride", "therapeutic_area_mesh": "Angina Pectoris;Heart Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01EB17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated: in adults unable to tolerate or with a contra-indication to the use of beta-blockers or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva, k.s.", "european_commission_decision_date": "15/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/11/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "11/11/2016", "last_updated_date": "17/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ivabradine-zentiva" }, { "category": "Human", "name_of_medicine": "Sugammadex Mylan", "ema_product_number": "EMEA/H/C/005403", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000267163", "international_non_proprietary_name_common_name": "sugammadex", "active_substance": "sugammadex sodium", "therapeutic_area_mesh": "Neuromuscular Blockade", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AB35", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "06/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "22/11/2021", "last_updated_date": "16/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sugammadex-mylan" }, { "category": "Human", "name_of_medicine": "Javlor", "ema_product_number": "EMEA/H/C/000983", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000272416", "international_non_proprietary_name_common_name": "vinflunine", "active_substance": "vinflunine", "therapeutic_area_mesh": "Carcinoma, Transitional Cell;Urologic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen. Efficacy and safety of vinflunine have not been studied in patients with performance status ? 2.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pierre Fabre Medicament", "european_commission_decision_date": "16/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "19/02/2018", "last_updated_date": "16/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/javlor" }, { "category": "Human", "name_of_medicine": "Natpar", "ema_product_number": "EMEA/H/C/003861", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000279755", "international_non_proprietary_name_common_name": "parathyroid hormone", "active_substance": "parathyroid hormone", "therapeutic_area_mesh": "Hypoparathyroidism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland Branch", "european_commission_decision_date": "11/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/04/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "22/08/2018", "last_updated_date": "15/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/natpar" }, { "category": "Human", "name_of_medicine": "Pomalidomide Krka", "ema_product_number": "EMEA/H/C/006314", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000267863", "international_non_proprietary_name_common_name": "pomalidomide", "active_substance": "Pomalidomide", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pomalidomide Krka in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Krka in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto ", "european_commission_decision_date": "10/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/07/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "27/05/2024", "last_updated_date": "14/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-krka" }, { "category": "Human", "name_of_medicine": "Plavix", "ema_product_number": "EMEA/H/C/000174", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000285292", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel hydrogen sulfate", "therapeutic_area_mesh": "Stroke;Peripheral Vascular Diseases;Atrial Fibrillation;Myocardial Infarction;Acute Coronary Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Secondary prevention of atherothrombotic events Clopidogrel is indicated in: adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease; adult patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS) \t\tClopidogrel in combination with ASA is indicated in: Adult patients with moderate to high-risk TIA (ABCD2  score ?4) or minor IS (NIHSS  ?3) within 24 hours of either the TIA or IS event. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "11/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/03/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/07/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "53", "first_published_date": "22/03/2018", "last_updated_date": "14/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/plavix" }, { "category": "Human", "name_of_medicine": "Ruxience", "ema_product_number": "EMEA/H/C/004696", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000263188", "international_non_proprietary_name_common_name": "rituximab", "active_substance": "rituximab", "therapeutic_area_mesh": "Leukemia, Lymphocytic, Chronic, B-Cell;Arthritis, Rheumatoid;Microscopic Polyangiitis;Pemphigus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ruxience is indicated in adults for the following indications: Non?Hodgkin’s lymphoma (NHL) Ruxience is indicated for the treatment of previously untreated patients with stage III?IV follicular lymphoma in combination with chemotherapy. Ruxience maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Ruxience monotherapy is indicated for treatment of patients with stage III?IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. Ruxience is indicated for the treatment of patients with CD20 positive diffuse large B cell non?Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Chronic lymphocytic leukaemia (CLL) Ruxience in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy. Rheumatoid arthritis Ruxience in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease?modifying anti?rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. Ruxience has been shown to reduce the rate of progression of joint damage as measured by X?ray and to improve physical function, when given in combination with methotrexate. Granulomatosis with polyangiitis and microscopic polyangiitis Ruxience, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). Pemphigus vulgaris Ruxience is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "11/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/04/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "07/04/2020", "last_updated_date": "14/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ruxience" }, { "category": "Human", "name_of_medicine": "Fluad", "ema_product_number": "EMEA/H/C/006538", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000272403", "international_non_proprietary_name_common_name": "influenza vaccine (surface antigen, inactivated, adjuvanted)", "active_substance": "A/Victoria/4897/2022 (H1N1)pdm09 like strain (A/Victoria/4897/2022, IVR-238);A/Croatia/10136RV/2023 (H3N2)-like strain (A/Croatia/10136RV/2023, X-425A);B/Austria/1359417/2021 like strain (B/Austria/1359417/2021, BVR-26)", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in adults 50 years of age and older. Fluad should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Seqirus Netherlands B.V.", "european_commission_decision_date": "09/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "18/10/2024", "last_updated_date": "14/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fluad" }, { "category": "Human", "name_of_medicine": "Fluenz", "ema_product_number": "EMEA/H/C/006514", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000272922", "international_non_proprietary_name_common_name": "influenza vaccine (live attenuated, nasal)", "active_substance": "influenza virus A/Victoria/4897/2022  (H1N1)pdm09 - like strain (A/Norway/31694/2022, MEDI 369815), A A/Croatia/10136RV/2023 (H3N2)-like strain (A/Perth/722/2024, MEDI 392611) B/Austria/1359417/2021 - like strain (B/ Austria/1359417/2021, MEDI 355292)", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fluenz is indicated for active immunisation for the prevention of influenza disease in children and adolescents from 2 years to less than 18 years of age.Fluenz should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "09/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/06/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "31/05/2024", "last_updated_date": "14/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fluenz" }, { "category": "Human", "name_of_medicine": "Sugammadex Fresenius Kabi", "ema_product_number": "EMEA/H/C/005760", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000265804", "international_non_proprietary_name_common_name": "sugammadex", "active_substance": "sugammadex sodium", "therapeutic_area_mesh": "Neuromuscular Blockade", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AB35", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "09/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/07/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "17/05/2022", "last_updated_date": "11/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sugammadex-fresenius-kabi" }, { "category": "Human", "name_of_medicine": "Epoetin Alfa Hexal", "ema_product_number": "EMEA/H/C/000726", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000278097", "international_non_proprietary_name_common_name": "epoetin alfa", "active_substance": "epoetin alfa", "therapeutic_area_mesh": "Anemia;Kidney Failure, Chronic;Blood Transfusion, Autologous;Myelodysplastic Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis; Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Hexal AG", "european_commission_decision_date": "11/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/08/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "04/10/2017", "last_updated_date": "11/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/epoetin-alfa-hexal" }, { "category": "Human", "name_of_medicine": "Binocrit", "ema_product_number": "EMEA/H/C/000725", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000278097", "international_non_proprietary_name_common_name": "epoetin alfa", "active_substance": "epoetin alfa", "therapeutic_area_mesh": "Anemia;Kidney Failure, Chronic;Blood Transfusion, Autologous;Myelodysplastic Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis; treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis; Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "11/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/08/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "04/10/2017", "last_updated_date": "11/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/binocrit" }, { "category": "Human", "name_of_medicine": "Abseamed", "ema_product_number": "EMEA/H/C/000727", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000278097", "international_non_proprietary_name_common_name": "epoetin alfa", "active_substance": "epoetin alfa", "therapeutic_area_mesh": "Anemia;Kidney Failure, Chronic;Blood Transfusion, Autologous;Myelodysplastic Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis; treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre existing anaemia at the start of chemotherapy). Abseamed can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (haemoglobin (Hb) 10-13 g/dl [6.2-8.1 mmol/l], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). Abseamed can be used to reduce exposure to allogeneic blood transfusions in adult non iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with an expected blood loss of 900 to 1800 ml.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Medice Arzneimittel Pütter GmbH Co. KG", "european_commission_decision_date": "11/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/08/2007", "refusal_of_marketing_authorisation_date": "18/06/2009", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "14/11/2016", "last_updated_date": "11/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abseamed" }, { "category": "Human", "name_of_medicine": "Kayfanda", "ema_product_number": "EMEA/H/C/006462", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000269338", "international_non_proprietary_name_common_name": "odevixibat", "active_substance": "odevixibat sesquihydrate", "therapeutic_area_mesh": "Pruritus;Alagille Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A05AX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bile and liver therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kayfanda is indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older (see sections 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ipsen Pharma", "european_commission_decision_date": "07/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "26/07/2024", "last_updated_date": "11/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kayfanda" }, { "category": "Human", "name_of_medicine": "Filsuvez", "ema_product_number": "EMEA/H/C/005035", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249374", "international_non_proprietary_name_common_name": "birch bark extract", "active_substance": "dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w)", "therapeutic_area_mesh": "Epidermolysis Bullosa Dystrophica;Epidermolysis Bullosa, Junctional", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D03AX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Preparations for treatment of wounds and ulcers", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A", "european_commission_decision_date": "15/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/06/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "13/04/2022", "last_updated_date": "11/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/filsuvez" }, { "category": "Human", "name_of_medicine": "Capecitabine Teva", "ema_product_number": "EMEA/H/C/002362", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282000", "international_non_proprietary_name_common_name": "capecitabine", "active_substance": "capecitabine", "therapeutic_area_mesh": "Colonic Neoplasms;Breast Neoplasms;Colorectal Neoplasms;Stomach Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer. Capecitabine Teva is indicated for the treatment of metastatic colorectal cancer. Capecitabine Teva is indicated for first?line treatment of advanced gastric cancer in combination with a platinum?based regimen. Capecitabine Teva in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine Teva is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "10/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/04/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "01/02/2018", "last_updated_date": "11/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/capecitabine-teva" }, { "category": "Human", "name_of_medicine": "Xbryk", "ema_product_number": "EMEA/H/C/006468", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000278769", "international_non_proprietary_name_common_name": "denosumab", "active_substance": "denosumab", "therapeutic_area_mesh": "Neoplasms, Bone Tissue;Giant Cell Tumor of Bone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1). Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "10/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "15/11/2024", "last_updated_date": "10/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xbryk" }, { "category": "Human", "name_of_medicine": "Temozolomide Sun", "ema_product_number": "EMEA/H/C/002198", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000271887", "international_non_proprietary_name_common_name": "temozolomide", "active_substance": "temozolomide", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Temozolomide Sun is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "10/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/07/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "03/08/2018", "last_updated_date": "10/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/temozolomide-sun" }, { "category": "Human", "name_of_medicine": "Evotaz", "ema_product_number": "EMEA/H/C/003904", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0050", "international_non_proprietary_name_common_name": "atazanavir;cobicistat", "active_substance": "cobicistat;atazanavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "EVOTAZ is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "02/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/07/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "22/02/2018", "last_updated_date": "10/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evotaz" }, { "category": "Human", "name_of_medicine": "Ituxredi", "ema_product_number": "EMEA/H/C/006224", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000264022", "international_non_proprietary_name_common_name": "rituximab", "active_substance": "rituximab", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell;Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukaemia (CLL) and rheumatoid arthritis", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Reddy Holding GmbH", "european_commission_decision_date": "09/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "26/07/2024", "last_updated_date": "09/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ituxredi" }, { "category": "Human", "name_of_medicine": "Filgrastim Hexal", "ema_product_number": "EMEA/H/C/000918", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2770", "international_non_proprietary_name_common_name": "filgrastim", "active_substance": "filgrastim", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. \tThe safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Mobilisation of peripheral blood progenitor cells (PBPCs). In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of of ? 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Treatment of persistent neutropenia (ANC ? 0.5 x 109/l), and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Hexal AG", "european_commission_decision_date": "20/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/02/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "24/05/2018", "last_updated_date": "08/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-hexal" }, { "category": "Human", "name_of_medicine": "Zarzio", "ema_product_number": "EMEA/H/C/000917", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2770", "international_non_proprietary_name_common_name": "filgrastim", "active_substance": "filgrastim", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Mobilisation of peripheral blood progenitor cells (PBPC). In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ?0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Treatment of persistent neutropenia (ANC ? 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "20/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/02/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "24/05/2018", "last_updated_date": "08/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zarzio" }, { "category": "Human", "name_of_medicine": "Obgemsa", "ema_product_number": "EMEA/H/C/005957", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000262389", "international_non_proprietary_name_common_name": "vibegron", "active_substance": "vibegron", "therapeutic_area_mesh": "Urinary Bladder, Overactive;Urinary Incontinence", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BD15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Obgemsa is indicated in symptomatic treatment of adult patients with overactive bladder (OAB) syndrome.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pierre Fabre Medicament", "european_commission_decision_date": "04/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/06/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "26/04/2024", "last_updated_date": "08/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/obgemsa" }, { "category": "Human", "name_of_medicine": "Holoclar", "ema_product_number": "EMEA/H/C/002450", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000262697", "international_non_proprietary_name_common_name": "ex vivo expanded autologous human corneal epithelial cells containing stem cells", "active_substance": "ex vivo expanded autologous human corneal epithelial cells containing stem cells", "therapeutic_area_mesh": "Stem Cell Transplantation;Corneal Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA19", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns. A minimum of 1-2 mm2 of undamaged limbus is required for biopsy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Holostem s.r.l.", "european_commission_decision_date": "07/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/12/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/02/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "22/06/2017", "last_updated_date": "08/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/holoclar" }, { "category": "Veterinary", "name_of_medicine": "Stronghold Plus", "ema_product_number": "EMEA/V/C/004194", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "selamectin;sarolaner", "active_substance": "selamectin;sarolaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents;Macrocyclic lactones;combinations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "07/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/stronghold-plus" }, { "category": "Veterinary", "name_of_medicine": "NexGard Combo", "ema_product_number": "EMEA/V/C/005094", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "esafoxolaner;eprinomectin;praziquantel", "active_substance": "eprinomectin;esafoxolaner;praziquantel", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Eprinomectin, combinations;Avermectins;Antiparasitic products, insecticides and repellents", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/04/2021", "last_updated_date": "07/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nexgard-combo" }, { "category": "Veterinary", "name_of_medicine": "Nobilis Multriva IBm+ND+Gm+REOm+EDS", "ema_product_number": "EMEA/V/C/005987", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian infectious bronchitis;Newcastle disease;avian infectious bursal disease;avian reovirus;egg drop syndrome virus vaccine (inactivated)", "active_substance": "infectious bronchitis virus, type Massachusetts, strain M41, inactivated ;infectious bronchitis virus, type 793/B, strain 4/91, inactivated;Newcastle disease virus, strain Ulster, inactivated;Infectious bursal disease virus, strain GB02, inactivated;Infectious bursal disease virus, strain 89/03, inactivated;inactivated avian reovirus strain ARV-1;inactivated avian reovirus strain ARV-4;Eggdrop syndrome-1976 virus, strain BC14, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/05/2025", "last_updated_date": "07/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-multriva-ibmndgmreomeds" }, { "category": "Human", "name_of_medicine": "Circadin", "ema_product_number": "EMEA/H/C/000695", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000285032", "international_non_proprietary_name_common_name": "melatonin", "active_substance": "melatonin", "therapeutic_area_mesh": "Sleep Initiation and Maintenance Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05CH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "RAD Neurim Pharmaceuticals EEC SARL", "european_commission_decision_date": "07/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/06/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "26/07/2018", "last_updated_date": "07/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/circadin" }, { "category": "Human", "name_of_medicine": "Hyftor", "ema_product_number": "EMEA/H/C/005896", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000282602", "international_non_proprietary_name_common_name": "sirolimus", "active_substance": "sirolimus", "therapeutic_area_mesh": "Angiofibroma;Tuberous Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Plusultra pharma GmbH", "european_commission_decision_date": "04/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/05/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "08/06/2023", "last_updated_date": "04/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hyftor" }, { "category": "Human", "name_of_medicine": "Rilonacept FGK Representative Service GmbH", "ema_product_number": "EMEA/H/C/006537", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rilonacept", "active_substance": "rilonacept", "therapeutic_area_mesh": "Pericarditis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of idiopathic pericarditis ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Rilonacept FGK Representative Service GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "12/02/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/02/2025", "last_updated_date": "04/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rilonacept-fgk-representative-service-gmbh" }, { "category": "Human", "name_of_medicine": "Orfadin", "ema_product_number": "EMEA/H/C/000555", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000265995", "international_non_proprietary_name_common_name": "nitisinone", "active_substance": "nitisinone", "therapeutic_area_mesh": "Tyrosinemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hereditary tyrosinemia type 1 (HT 1)Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine. Alkaptonuria (AKU)Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Swedish Orphan Biovitrum International AB", "european_commission_decision_date": "03/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/11/2004", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/02/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "26/01/2017", "last_updated_date": "04/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orfadin" }, { "category": "Human", "name_of_medicine": "Neoatricon", "ema_product_number": "EMEA/H/C/006044", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000279197", "international_non_proprietary_name_common_name": "dopamine hydrochloride", "active_substance": "dopamine hydrochloride;Dopamine", "therapeutic_area_mesh": "Hypotension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01CA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of hypotension in haemodynamically unstable neonates, infants and children < 18 years", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BrePco Biopharma Limited", "european_commission_decision_date": "27/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/05/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "22/03/2024", "last_updated_date": "04/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neoatricon" }, { "category": "Human", "name_of_medicine": "Cufence", "ema_product_number": "EMEA/H/C/004111", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0020", "international_non_proprietary_name_common_name": "trientine dihydrochloride", "active_substance": "trientine dihydrochloride", "therapeutic_area_mesh": "Hepatolenticular Degeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16A", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cufence is indicated for the treatment of Wilson’s disease in patients intolerant to D-Penicillamine therapy, in adults and children aged 5 years or older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Univar Solutions BV", "european_commission_decision_date": "25/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/05/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/07/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "29/07/2019", "last_updated_date": "02/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cufence" }, { "category": "Human", "name_of_medicine": "Idefirix", "ema_product_number": "EMEA/H/C/004849", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0000249767", "international_non_proprietary_name_common_name": "imlifidase", "active_substance": "imlifidase", "therapeutic_area_mesh": "Desensitization, Immunologic;Kidney Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of Idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Hansa Biopharma AB", "european_commission_decision_date": "25/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/08/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "28/08/2020", "last_updated_date": "02/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/idefirix" }, { "category": "Human", "name_of_medicine": "Busulfan Fresenius Kabi", "ema_product_number": "EMEA/H/C/002806", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000279217", "international_non_proprietary_name_common_name": "busulfan", "active_substance": "busulfan", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Alkyl sulfonates", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option. Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "01/07/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/09/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "08/05/2018", "last_updated_date": "01/07/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/busulfan-fresenius-kabi" }, { "category": "Human", "name_of_medicine": "BroPair Spiromax", "ema_product_number": "EMEA/H/C/005591", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000258678", "international_non_proprietary_name_common_name": "salmeterol;fluticasone propionate", "active_substance": "salmeterol xinafoate;fluticasone propionate", "therapeutic_area_mesh": "Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "BroPair Spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting ?? agonists.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "01/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "23/05/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "14/04/2021", "last_updated_date": "30/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bropair-spiromax" }, { "category": "Human", "name_of_medicine": "Emtricitabine/Tenofovir disoproxil Mylan", "ema_product_number": "EMEA/H/C/004050", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000279174", "international_non_proprietary_name_common_name": "emtricitabine;tenofovir disoproxil", "active_substance": "emtricitabine;tenofovir disoproxil maleate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of HIV-1 infection: Emtricitabine/Tenofovir disoproxil Mylan is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1). Emtricitabine/Tenofovir disoproxil Mylan is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1). Pre-exposure prophylaxis (PrEP): Emtricitabine/Tenofovir disoproxil Mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "27/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/12/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "02/06/2017", "last_updated_date": "30/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabine-tenofovir-disoproxil-mylan" }, { "category": "Human", "name_of_medicine": "Vyjuvek", "ema_product_number": "EMEA/H/C/006330", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000281025", "international_non_proprietary_name_common_name": "beremagene geperpavec", "active_substance": "Beremagene geperpavec", "therapeutic_area_mesh": "Epidermolysis Bullosa Dystrophica", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D03AX16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Preparations for treatment of wounds and ulcers", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vyjuvek is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Krystal Biotech Netherlands B.V.", "european_commission_decision_date": "26/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/02/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "28/02/2025", "last_updated_date": "30/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vyjuvek" }, { "category": "Human", "name_of_medicine": "Avamys", "ema_product_number": "EMEA/H/C/000770", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000272178", "international_non_proprietary_name_common_name": "fluticasone furoate", "active_substance": "fluticasone furoate", "therapeutic_area_mesh": "Rhinitis, Allergic, Seasonal;Rhinitis, Allergic, Perennial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R01AD12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Nasal preparations;Corticosteroids", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "25/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "18/08/2017", "last_updated_date": "27/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/avamys" }, { "category": "Human", "name_of_medicine": "Tresiba", "ema_product_number": "EMEA/H/C/002498", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000254608", "international_non_proprietary_name_common_name": "insulin degludec", "active_substance": "insulin degludec", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "26/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/01/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "10/07/2018", "last_updated_date": "27/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tresiba" }, { "category": "Human", "name_of_medicine": "Zoonotic Influenza Vaccine Seqirus", "ema_product_number": "EMEA/H/C/006375", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000249071", "international_non_proprietary_name_common_name": "zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted)", "active_substance": "A/Astrakhan/3212/2020 (H5N8)-like strain (CBER-RG8A) (clade 2.3.4.4b)", "therapeutic_area_mesh": "Influenza A Virus, H5N8 Subtype", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zoonotic Influenza Vaccine Seqirus H5N8 is indicated for active immunisation against H5 subtype influenza A viruses in individuals 6 months of age and above. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Seqirus S.r.l. ", "european_commission_decision_date": "12/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/10/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "14/09/2023", "last_updated_date": "27/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zoonotic-influenza-vaccine-seqirus" }, { "category": "Human", "name_of_medicine": "Miglustat Dipharma", "ema_product_number": "EMEA/H/C/004904", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000263310", "international_non_proprietary_name_common_name": "miglustat", "active_substance": "miglustat", "therapeutic_area_mesh": "Gaucher Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Miglustat Dipharma is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Miglustat Dipharma may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Miglustat Dipharma is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dipharma Arzneimittel GmbH", "european_commission_decision_date": "16/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/12/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/02/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "11/12/2018", "last_updated_date": "25/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/miglustat-dipharma" }, { "category": "Human", "name_of_medicine": "Foclivia", "ema_product_number": "EMEA/H/C/001208", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000274004", "international_non_proprietary_name_common_name": "pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)", "active_substance": "influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1)", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Influenza vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Seqirus S.r.l. ", "european_commission_decision_date": "16/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "03/11/2016", "last_updated_date": "25/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/foclivia" }, { "category": "Human", "name_of_medicine": "Miglustat Gen.Orph", "ema_product_number": "EMEA/H/C/004366", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000279222", "international_non_proprietary_name_common_name": "miglustat", "active_substance": "miglustat", "therapeutic_area_mesh": "Gaucher Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Miglustat Gen.Orph is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.  Miglustat Gen.Orph may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Miglustat Gen.Orph is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gen.Orph", "european_commission_decision_date": "24/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "02/03/2018", "last_updated_date": "24/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/miglustat-genorph" }, { "category": "Human", "name_of_medicine": "Cotellic", "ema_product_number": "EMEA/H/C/003960", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000279872", "international_non_proprietary_name_common_name": "cobimetinib", "active_substance": "cobimetinib hemifumarate", "therapeutic_area_mesh": "Melanoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE38", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "24/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "09/08/2018", "last_updated_date": "24/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cotellic" }, { "category": "Human", "name_of_medicine": "Zessly", "ema_product_number": "EMEA/H/C/004647", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000271864", "international_non_proprietary_name_common_name": "infliximab", "active_substance": "infliximab", "therapeutic_area_mesh": "Arthritis, Psoriatic;Psoriasis;Crohn Disease;Arthritis, Rheumatoid;Colitis, Ulcerative;Spondylitis, Ankylosing", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "19/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/03/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/05/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "18/05/2018", "last_updated_date": "24/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zessly" }, { "category": "Human", "name_of_medicine": "Grepid", "ema_product_number": "EMEA/H/C/001059", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000280379", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as besilate)", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of atherothrombotic events Clopidogrel is indicated in: adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease; adult patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharmathen S.A.", "european_commission_decision_date": "20/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/05/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "31/05/2018", "last_updated_date": "23/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/grepid" }, { "category": "Human", "name_of_medicine": "Memantine Merz", "ema_product_number": "EMEA/H/C/002711", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000248882", "international_non_proprietary_name_common_name": "memantine hydrochloride", "active_substance": "memantine hydrochloride", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other anti-dementia drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with moderate to severe Alzheimer’s disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merz Pharmaceuticals GmbH  ", "european_commission_decision_date": "19/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "13/07/2017", "last_updated_date": "20/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/memantine-merz" }, { "category": "Human", "name_of_medicine": "Yorvipath", "ema_product_number": "EMEA/H/C/005934", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000247280", "international_non_proprietary_name_common_name": "palopegteriparatide", "active_substance": "palopegteriparatide", "therapeutic_area_mesh": "Hypoparathyroidism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Yorvipath is a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ascendis Pharma Bone Diseases A/S", "european_commission_decision_date": "10/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/11/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "15/09/2023", "last_updated_date": "20/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yorvipath" }, { "category": "Human", "name_of_medicine": "Axura", "ema_product_number": "EMEA/H/C/000378", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000248882", "international_non_proprietary_name_common_name": "memantine", "active_substance": "memantine hydrochloride", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other anti-dementia drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with moderate to severe Alzheimer's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merz Pharmaceuticals GmbH", "european_commission_decision_date": "19/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/02/2002", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/05/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "26/06/2018", "last_updated_date": "20/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/axura" }, { "category": "Human", "name_of_medicine": "Colobreathe", "ema_product_number": "EMEA/H/C/001225", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0063", "international_non_proprietary_name_common_name": "colistimethate sodium", "active_substance": "Colistimethate sodium", "therapeutic_area_mesh": "Cystic Fibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01XB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged six years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Essential Pharma Limited", "european_commission_decision_date": "18/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/02/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "08/08/2018", "last_updated_date": "20/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/colobreathe" }, { "category": "Human", "name_of_medicine": "Zelboraf", "ema_product_number": "EMEA/H/C/002409", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000279644", "international_non_proprietary_name_common_name": "vemurafenib", "active_substance": "vemurafenib", "therapeutic_area_mesh": "Melanoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "19/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/02/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "14/08/2018", "last_updated_date": "19/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zelboraf" }, { "category": "Human", "name_of_medicine": "Jetrea", "ema_product_number": "EMEA/H/C/002381", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0053", "international_non_proprietary_name_common_name": "ocriplasmin", "active_substance": "ocriplasmin", "therapeutic_area_mesh": "Retinal Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Jetrea is indicated in adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Inceptua AB", "european_commission_decision_date": "11/12/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/01/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/03/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "30/08/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "30/07/2018", "last_updated_date": "19/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jetrea" }, { "category": "Human", "name_of_medicine": "Pergoveris", "ema_product_number": "EMEA/H/C/000714", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000267259", "international_non_proprietary_name_common_name": "follitropin alfa;lutropin alfa", "active_substance": "follitropin alfa;lutropin alfa", "therapeutic_area_mesh": "Infertility, Female", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03GA30", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pergoveris is indicated for the stimulation of follicular development in women with severe luteinising-hormone (LH) and follicle-stimulating-hormone deficiency. In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/l.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Europe B.V. ", "european_commission_decision_date": "17/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/06/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "20/08/2018", "last_updated_date": "18/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pergoveris" }, { "category": "Human", "name_of_medicine": "Cinryze", "ema_product_number": "EMEA/H/C/001207", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0104", "international_non_proprietary_name_common_name": "C1 inhibitor (human)", "active_substance": "C1 inhibitor (human)", "therapeutic_area_mesh": "Angioedemas, Hereditary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "c1-inhibitor, plasma derived;Drugs used in hereditary angioedema", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (HAE). Routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Manufacturing Austria AG", "european_commission_decision_date": "08/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/03/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/06/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "20/03/2018", "last_updated_date": "18/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cinryze" }, { "category": "Human", "name_of_medicine": "Phelinun", "ema_product_number": "EMEA/H/C/005173", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0005", "international_non_proprietary_name_common_name": "melphalan", "active_substance": "melphalan hydrochloride", "therapeutic_area_mesh": "Multiple Myeloma;Hodgkin Disease;Lymphoma, Non-Hodgkin;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Leukemia, Myeloid, Acute;Neuroblastoma;Ovarian Neoplasms;Hematopoietic Stem Cell Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of: multiple myeloma, malignant lymphoma (Hodgkin, non-Hodgkin lymphoma), acute lymphoblastic and myeloblastic leukemia, childhood neuroblastoma, ovarian cancer, mammary adenocarcinoma. Phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults. Phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as: Myeloablative conditioning (MAC) treatment in case of malignant haematological diseases RIC treatment in case of non-malignant haematological diseases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ADIENNE S.r.l. S.U.", "european_commission_decision_date": "22/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/09/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/11/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "25/11/2020", "last_updated_date": "18/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/phelinun" }, { "category": "Human", "name_of_medicine": "TachoSil", "ema_product_number": "EMEA/H/C/000505", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0131", "international_non_proprietary_name_common_name": "human fibrinogen;human thrombin", "active_substance": "human fibrinogen;human thrombin", "therapeutic_area_mesh": "Hemostasis, Surgical", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BC30", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "TachoSil is indicated in adults and children from 1 month of age for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. TachoSil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Corza Medical GmbH", "european_commission_decision_date": "08/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/06/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "25/05/2018", "last_updated_date": "17/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tachosil" }, { "category": "Human", "name_of_medicine": "Lumeblue (previously Methylthioninium chloride Cosmo)", "ema_product_number": "EMEA/H/C/002776", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0007", "international_non_proprietary_name_common_name": "methylthioninium chloride", "active_substance": "methylthioninium chloride", "therapeutic_area_mesh": "Colorectal Neoplasms;Colonoscopy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V04CX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other diagnostic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cosmo Technologies Ltd", "european_commission_decision_date": "22/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/08/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "26/08/2020", "last_updated_date": "17/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lumeblue" }, { "category": "Human", "name_of_medicine": "Rivastigmine Actavis", "ema_product_number": "EMEA/H/C/002036", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000278907", "international_non_proprietary_name_common_name": "rivastigmine", "active_substance": "rivastigmine hydrogen tartrate", "therapeutic_area_mesh": "Dementia;Alzheimer Disease;Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "13/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/06/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "04/04/2018", "last_updated_date": "13/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rivastigmine-actavis" }, { "category": "Veterinary", "name_of_medicine": "Biobhyo", "ema_product_number": "EMEA/V/C/006336", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Swine dysentery vaccine (inactivated)", "active_substance": "Brachyspira hyodysenteriae, strain AqDys057, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/06/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/biobhyo" }, { "category": "Human", "name_of_medicine": "Zerbaxa", "ema_product_number": "EMEA/H/C/003772", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000263946", "international_non_proprietary_name_common_name": "ceftolozane;tazobactam", "active_substance": "ceftolozane sulfate;tazobactam sodium", "therapeutic_area_mesh": "Bacterial Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01DI54", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zerbaxa is indicated for the treatment of the following infections in adults: Complicated intra abdominal infections; Acute pyelonephritis; Complicated urinary tract infections; Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "16/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "08/05/2018", "last_updated_date": "12/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zerbaxa" }, { "category": "Human", "name_of_medicine": "Nyxoid", "ema_product_number": "EMEA/H/C/004325", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0019", "international_non_proprietary_name_common_name": "naloxone", "active_substance": "naloxone hydrochloride dihydrate", "therapeutic_area_mesh": "Opiate Overdose", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AB15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings. Nyxoid is indicated in adults and adolescents aged 14 years and over. Nyxoid is not a substitute for emergency medical care.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mundipharma Corporation (Ireland) Limited", "european_commission_decision_date": "25/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "10/01/2018", "last_updated_date": "12/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nyxoid" }, { "category": "Human", "name_of_medicine": "Zostavax", "ema_product_number": "EMEA/H/C/000674", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0142/G", "international_non_proprietary_name_common_name": "shingles (herpes zoster) vaccine (live)", "active_substance": "varicella-zoster virus (live, attenuated)", "therapeutic_area_mesh": "Herpes Zoster;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BK02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Viral vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zostavax is indicated for prevention of herpes zoster ('zoster' or shingles) and herpes-zoster-related post-herpetic neuralgia. Zostavax is indicated for immunisation of individuals 50 years of age or older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "30/06/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/03/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/05/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/06/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "15/01/2018", "last_updated_date": "11/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zostavax" }, { "category": "Human", "name_of_medicine": "Rozlytrek", "ema_product_number": "EMEA/H/C/004936", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010874/202406", "international_non_proprietary_name_common_name": "entrectinib", "active_substance": "Entrectinib", "therapeutic_area_mesh": "Cancer;Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor who have no satisfactory treatment options. Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH ", "european_commission_decision_date": "24/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/05/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/07/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "11/09/2020", "last_updated_date": "10/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rozlytrek" }, { "category": "Human", "name_of_medicine": "Vokanamet", "ema_product_number": "EMEA/H/C/002656", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000261685", "international_non_proprietary_name_common_name": "canagliflozin;metformin", "active_substance": "canagliflozin;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vokanamet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: in patients not adequately controlled on their maximally tolerated doses of metformin alone in patients on their maximally tolerated doses of metformin along with other glucose lowering medicinal products including insulin, when these do not provide adequate glycaemic control. in patients already being treated with the combination of canagliflozin and metformin as separate tablets For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "10/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "15/03/2018", "last_updated_date": "10/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vokanamet" }, { "category": "Human", "name_of_medicine": "Apexelsin", "ema_product_number": "EMEA/H/C/005997", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000272569", "international_non_proprietary_name_common_name": "paclitaxel", "active_substance": "paclitaxel", "therapeutic_area_mesh": "Breast Neoplasms;Pancreatic Neoplasms;Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Apexelsin monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Apexelsin in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Apexelsin in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Whiteoak Pharmaceutical B.V.", "european_commission_decision_date": "10/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/07/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "31/05/2024", "last_updated_date": "10/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/apexelsin" }, { "category": "Human", "name_of_medicine": "Jyseleca", "ema_product_number": "EMEA/H/C/005113", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0038", "international_non_proprietary_name_common_name": "filgotinib", "active_substance": "filgotinib maleate", "therapeutic_area_mesh": "Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AF04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). Ulcerative colitis Jyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Alfasigma S.p.A.", "european_commission_decision_date": "02/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/09/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "26/05/2020", "last_updated_date": "10/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jyseleca" }, { "category": "Human", "name_of_medicine": "Pelgraz Paediatric", "ema_product_number": "EMEA/H/C/006348", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "Neutropenia;Febrile Neutropenia;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neutropenia in paediatric patients", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/02/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/02/2025", "last_updated_date": "04/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz-paediatric" }, { "category": "Human", "name_of_medicine": "Beqvez (previously Durveqtix)", "ema_product_number": "EMEA/H/C/004774", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0001", "international_non_proprietary_name_common_name": "fidanacogene elaparvovec", "active_substance": "fidanacogene elaparvovec", "therapeutic_area_mesh": "Hemophilia B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "24/09/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/07/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/05/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "31/05/2024", "last_updated_date": "04/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/beqvez" }, { "category": "Human", "name_of_medicine": "Zeffix", "ema_product_number": "EMEA/H/C/000242", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000262168", "international_non_proprietary_name_common_name": "lamivudine", "active_substance": "lamivudine", "therapeutic_area_mesh": "Hepatitis B, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zeffix is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate; decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "26/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/07/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "25/01/2018", "last_updated_date": "03/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zeffix" }, { "category": "Human", "name_of_medicine": "Cholestagel", "ema_product_number": "EMEA/H/C/000512", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000267594", "international_non_proprietary_name_common_name": "colesevelam", "active_substance": "colesevelam (as hydrochloride)", "therapeutic_area_mesh": "Hypercholesterolemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA)-reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density-lipoprotein-cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone. Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated. Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CHEPLAPHARM Arzneimittel GmbH", "european_commission_decision_date": "03/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/03/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "28/04/2017", "last_updated_date": "03/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cholestagel" }, { "category": "Human", "name_of_medicine": "Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)", "ema_product_number": "EMEA/H/C/002785", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000275731", "international_non_proprietary_name_common_name": "levodopa;carbidopa;entacapone", "active_substance": "levodopa;carbidopa;entacapone", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Corbilta is indicated for the treatment of adult patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Orion Corporation", "european_commission_decision_date": "02/06/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/11/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "06/07/2018", "last_updated_date": "02/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/corbilta" }, { "category": "Veterinary", "name_of_medicine": "Hepizovac", "ema_product_number": "EMEA/V/C/006592", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "epizootic haemorrhagic disease vaccine (inactivated)", "active_substance": "epizootic haemorrhagic disease virus (EHDV), serotype 8, strain EHDV8 SPA 2022/LCV_03 LCV Cod.:O78", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/03/2025", "last_updated_date": "02/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/hepizovac" }, { "category": "Veterinary", "name_of_medicine": "Prazivetin", "ema_product_number": "EMEA/V/C/006247", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "praziquantel", "active_substance": "praziquantel", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents;Anthelmintics;Quinoline derivatives and related substances", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/03/2025", "last_updated_date": "02/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/prazivetin" }, { "category": "Veterinary", "name_of_medicine": "Prevestrus vet", "ema_product_number": "EMEA/V/C/006235", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "finrozole", "active_substance": "finrozole", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Genito urinary system and sex hormones;Sex hormones and modulators of the genital system", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/03/2025", "last_updated_date": "02/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/prevestrus-vet" }, { "category": "Veterinary", "name_of_medicine": "Nobilis Multriva IBm+ND+EDS", "ema_product_number": "EMEA/V/C/006522", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "infectious bronchitis;Newcastle disease;egg drop syndrome virus vaccine (inactivated)", "active_substance": "infectious bronchitis virus, type Massachusetts, strain M41, inactivated ;infectious bronchitis virus, type 793/B, strain 4/91, inactivated;Newcastle disease virus, strain Ulster, inactivated;Eggdrop syndrome-1976 virus, strain BC14, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/03/2025", "last_updated_date": "02/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-multriva-ibmndeds" }, { "category": "Human", "name_of_medicine": "Temozolomide Accord", "ema_product_number": "EMEA/H/C/001125", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000272235", "international_non_proprietary_name_common_name": "temozolomide", "active_substance": "temozolomide", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "28/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/12/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/03/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "23/05/2018", "last_updated_date": "02/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/temozolomide-accord" }, { "category": "Veterinary", "name_of_medicine": "Rheumocam", "ema_product_number": "EMEA/V/C/000121", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Oxicams;Anti-inflammatory and anti-rheumatic products, non-steroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "07/09/2016", "last_updated_date": "02/06/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/rheumocam" }, { "category": "Human", "name_of_medicine": "NovoRapid", "ema_product_number": "EMEA/H/C/000258", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000272759", "international_non_proprietary_name_common_name": "insulin aspart", "active_substance": "insulin aspart", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "NovoRapid is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "28/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/09/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "26/04/2018", "last_updated_date": "28/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/novorapid" }, { "category": "Human", "name_of_medicine": "Xolair", "ema_product_number": "EMEA/H/C/000606", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000273476", "international_non_proprietary_name_common_name": "omalizumab", "active_substance": "omalizumab", "therapeutic_area_mesh": "Asthma;Urticaria;Rhinitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03DX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Allergic asthma Xolair is indicated in adults, adolescents and children (6 to <12 years of age). Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma. Adults and adolescents (12 years of age and older) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Children (6 to <12 years of age) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Chronic rhinosinusitis with nasal polyps (CRSwNP) Xolair is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control. Chronic spontaneous urticaria (CSU) Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "21/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/07/2005", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/10/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "52", "first_published_date": "31/05/2018", "last_updated_date": "28/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xolair" }, { "category": "Human", "name_of_medicine": "Lacosamide Accord", "ema_product_number": "EMEA/H/C/004443", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000274929", "international_non_proprietary_name_common_name": "lacosamide", "active_substance": "lacosamide", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lacosamide Accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. Lacosamide Accord is indicated as adjunctive therapy •         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. •         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "28/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "04/04/2018", "last_updated_date": "28/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lacosamide-accord" }, { "category": "Human", "name_of_medicine": "Pemetrexed medac", "ema_product_number": "EMEA/H/C/003905", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000261770", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Mesothelioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Folic acid analogues;Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed medac in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed medac is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed medac is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "european_commission_decision_date": "28/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "18/05/2018", "last_updated_date": "28/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-medac" }, { "category": "Human", "name_of_medicine": "Privigen", "ema_product_number": "EMEA/H/C/000831", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0210", "international_non_proprietary_name_common_name": "human normal immunoglobulin (IVIg)", "active_substance": "human normal immunoglobulin (IVIg)", "therapeutic_area_mesh": "Purpura, Thrombocytopenic, Idiopathic;Bone Marrow Transplantation;Immunologic Deficiency Syndromes;Guillain-Barre Syndrome;Mucocutaneous Lymph Node Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Replacement therapy in adults, and children and adolescents (0-18 years) in: primary immunodeficiency (PID) syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who have failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, and children and adolescents (0-18 years) in: primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain-Barré syndrome; Kawasaki disease; chronic inflammatory demyelinating polyneuropathy (CIDP). Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CSL Behring GmbH", "european_commission_decision_date": "25/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/02/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/04/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "28/11/2017", "last_updated_date": "28/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/privigen" }, { "category": "Human", "name_of_medicine": "Ovaleap", "ema_product_number": "EMEA/H/C/002608", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000248727", "international_non_proprietary_name_common_name": "follitropin alfa", "active_substance": "follitropin alfa", "therapeutic_area_mesh": "Anovulation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03GA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "In adult women Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate; Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer; Ovaleap in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L. In adult men Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Theramex Ireland Limited", "european_commission_decision_date": "16/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "16/05/2018", "last_updated_date": "27/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ovaleap" }, { "category": "Human", "name_of_medicine": "Kinselby", "ema_product_number": "EMEA/H/C/006259", "medicine_status": "Opinion", "opinion_status": "Negative", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "resminostat", "active_substance": "resminostat mesilate", "therapeutic_area_mesh": "Mycosis Fungoides;Sezary Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with advanced stage mycosis fungoides (MF) and Sézary syndrome (SS)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "4Sc AG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/05/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kinselby" }, { "category": "Human", "name_of_medicine": "Cinainu", "ema_product_number": "EMEA/H/C/004155", "medicine_status": "Application withdrawn", "opinion_status": "Negative", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dry aqueous extract of paullinia cupana seed;dry hydroethanolic extract of theobroma cacao seed;liquid ethanolic extract 30 per cent (W/W) of Allium cepa fresh bulb and Citrus limon fresh fruit", "active_substance": "dry aqueous extract of paullinia cupana seed;dry hydroethanolic extract of theobroma cacao seed;liquid ethanolic extract 30 per cent (W/W) of Allium cepa fresh bulb and Citrus limon fresh fruit", "therapeutic_area_mesh": "Alopecia Areata", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other dermatologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of alopecia areata in children and adolescents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Legacy Healthcare (France) S.A.S.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2024", "withdrawal_of_application_date": "26/02/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/03/2025", "last_updated_date": "26/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cinainu" }, { "category": "Human", "name_of_medicine": "Lacosamide UCB", "ema_product_number": "EMEA/H/C/005243", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000266348", "international_non_proprietary_name_common_name": "lacosamide", "active_substance": "lacosamide", "therapeutic_area_mesh": "Epilepsies, Partial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma S.A.", "european_commission_decision_date": "12/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/08/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "12/09/2019", "last_updated_date": "23/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lacosamide-ucb" }, { "category": "Human", "name_of_medicine": "Ovitrelle", "ema_product_number": "EMEA/H/C/000320", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000267272", "international_non_proprietary_name_common_name": "choriogonadotropin alfa", "active_substance": "choriogonadotropin alfa", "therapeutic_area_mesh": "Anovulation;Reproductive Techniques, Assisted;Infertility, Female", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03GA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ovitrelle is indicated in the treatment of: women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth; anovulatory or oligo-ovulatory women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Europe B.V.", "european_commission_decision_date": "23/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/10/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/02/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "04/12/2016", "last_updated_date": "23/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ovitrelle" }, { "category": "Human", "name_of_medicine": "Pedmarqsi", "ema_product_number": "EMEA/H/C/005130", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000263648", "international_non_proprietary_name_common_name": "sodium thiosulfate", "active_substance": "sodium thiosulfate", "therapeutic_area_mesh": "Ear Diseases;Ototoxicity", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Norgine B.V.", "european_commission_decision_date": "22/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/05/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "02/06/2023", "last_updated_date": "23/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pedmarqsi" }, { "category": "Human", "name_of_medicine": "Komboglyze", "ema_product_number": "EMEA/H/C/002059", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000258017", "international_non_proprietary_name_common_name": "saxagliptin;metformin hydrochloride", "active_substance": "metformin hydrochloride;saxagliptin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Combinations of oral blood glucose lowering drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets. Komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB ", "european_commission_decision_date": "08/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/11/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "26/06/2017", "last_updated_date": "23/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/komboglyze" }, { "category": "Human", "name_of_medicine": "Teriparatide Ascend", "ema_product_number": "EMEA/H/C/005687", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "teriparatide", "active_substance": "teriparatide", "therapeutic_area_mesh": "Osteoporosis;Osteoporosis, Postmenopausal;Bone Resorption", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ascend GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "06/05/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/05/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/teriparatide-ascend" }, { "category": "Human", "name_of_medicine": "Revestive", "ema_product_number": "EMEA/H/C/002345", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000272450", "international_non_proprietary_name_common_name": "teduglutide", "active_substance": "teduglutide", "therapeutic_area_mesh": "Malabsorption Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery. Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland", "european_commission_decision_date": "22/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/08/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "22/01/2018", "last_updated_date": "23/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/revestive" }, { "category": "Human", "name_of_medicine": "Nerlynx", "ema_product_number": "EMEA/H/C/004030", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000265110", "international_non_proprietary_name_common_name": "neratinib", "active_substance": "neratinib", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EH02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pierre Fabre Medicament", "european_commission_decision_date": "22/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/06/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/08/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "31/08/2018", "last_updated_date": "23/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nerlynx" }, { "category": "Human", "name_of_medicine": "Conbriza", "ema_product_number": "EMEA/H/C/000913", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000268528", "international_non_proprietary_name_common_name": "bazedoxifene", "active_substance": "bazedoxifene", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03XC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Conbriza is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. A significant reduction in the incidence of vertebral fractures has been demonstrated; efficacy on hip fractures has not been established. When determining the choice of Conbriza or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "19/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/02/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/04/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "02/08/2018", "last_updated_date": "20/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/conbriza" }, { "category": "Human", "name_of_medicine": "Pelgraz", "ema_product_number": "EMEA/H/C/003961", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000272230", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "19/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "26/10/2018", "last_updated_date": "19/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz" }, { "category": "Human", "name_of_medicine": "Brinavess", "ema_product_number": "EMEA/H/C/001215", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0044", "international_non_proprietary_name_common_name": "vernakalant hydrochloride", "active_substance": "vernakalant hydrochloride", "therapeutic_area_mesh": "Atrial Fibrillation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01BG11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults: for non-surgery patients: atrial fibrillation </= 7 days duration; for post-cardiac surgery patients: atrial fibrillation </= 3 days duration.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Advanz Pharma Limited", "european_commission_decision_date": "19/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/09/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "09/01/2018", "last_updated_date": "19/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/brinavess" }, { "category": "Human", "name_of_medicine": "Vipdomet", "ema_product_number": "EMEA/H/C/002654", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000263319", "international_non_proprietary_name_common_name": "alogliptin;metformin", "active_substance": "alogliptin benzoate;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Combinations of oral blood glucose lowering drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vipdomet is indicated in the treatment of adult patients aged 18 years and older with type-2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin; in combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone; in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "19/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "16/10/2017", "last_updated_date": "19/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vipdomet" }, { "category": "Human", "name_of_medicine": "Buprenorphine Neuraxpharm", "ema_product_number": "EMEA/H/C/006188", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000267606", "international_non_proprietary_name_common_name": "buprenorphine", "active_substance": "buprenorphine hydrochloride", "therapeutic_area_mesh": "Opioid-Related Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07BC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Substitution treatment of opioid drug dependence, within a comprehensive therapeutic monitoring framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents 15 years of age and older, who have agreed to be treated for addiction.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Neuraxpharm Pharmaceuticals S.L.", "european_commission_decision_date": "16/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/12/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "18/10/2024", "last_updated_date": "16/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/buprenorphine-neuraxpharm" }, { "category": "Human", "name_of_medicine": "Deqsiga", "ema_product_number": "EMEA/H/C/006423", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "human normal immunoglobulin", "active_substance": "human normal immunoglobulin", "therapeutic_area_mesh": "Immunologic Deficiency Syndromes;Purpura, Thrombocytopenic, Idiopathic;Guillain-Barre Syndrome;Mucocutaneous Lymph Node Syndrome;Polyradiculoneuropathy, Chronic Inflammatory Demyelinating", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Replacement therapy in adults, children and adolescents (0 to 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production.  - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of < 4 g/L.*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccinesImmunomodulation in adults, children and adolescents (0 to 18 years) in: - Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - Guillain Barré syndrome. - Kawasaki disease (in conjunction with acetylsalicylic acid; see section 4.2). - Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). - Multifocal Motor Neuropathy (MMN).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Manufacturing Austria AG", "european_commission_decision_date": "02/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/02/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/05/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/02/2025", "last_updated_date": "16/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/deqsiga" }, { "category": "Human", "name_of_medicine": "Riluzole Zentiva", "ema_product_number": "EMEA/H/C/002622", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000269434", "international_non_proprietary_name_common_name": "riluzole", "active_substance": "riluzole", "therapeutic_area_mesh": "Amyotrophic Lateral Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS. Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor-neurone disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva k.s.", "european_commission_decision_date": "15/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/05/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "08/05/2018", "last_updated_date": "15/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/riluzole-zentiva" }, { "category": "Human", "name_of_medicine": "Rytelo", "ema_product_number": "EMEA/H/C/006105", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000272668", "international_non_proprietary_name_common_name": "imetelstat", "active_substance": "imetelstat", "therapeutic_area_mesh": "Anemia;Myelodysplastic Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX80", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of transfusion-dependent anaemia in adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Geron Netherlands B.V.", "european_commission_decision_date": "14/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/03/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "13/12/2024", "last_updated_date": "15/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rytelo" }, { "category": "Human", "name_of_medicine": "Faslodex", "ema_product_number": "EMEA/H/C/000540", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000248153", "international_non_proprietary_name_common_name": "fulvestrant", "active_substance": "fulvestrant", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy;Anti-estrogens", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "14/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/03/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "21/03/2018", "last_updated_date": "15/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/faslodex" }, { "category": "Human", "name_of_medicine": "Clopidogrel Krka", "ema_product_number": "EMEA/H/C/001056", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000267857", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrochloride)", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "14/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "17/04/2018", "last_updated_date": "14/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-krka" }, { "category": "Human", "name_of_medicine": "Zyllt", "ema_product_number": "EMEA/H/C/001058", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000268052", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrogen sulfate)", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Acute Coronary Syndrome;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation: - In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "13/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "24/04/2018", "last_updated_date": "14/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zyllt" }, { "category": "Human", "name_of_medicine": "Clopidogrel Krka d.d. (previously Zopya)", "ema_product_number": "EMEA/H/C/001137", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000267861", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrochloride)", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35days), ischaemic stroke (from 7days until less than 6months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Norpharm Regulatory Services Ltd", "european_commission_decision_date": "13/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "06/07/2017", "last_updated_date": "13/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-krka-dd" }, { "category": "Human", "name_of_medicine": "Clopidogrel TAD", "ema_product_number": "EMEA/H/C/001136", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000268055", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrochloride)", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Tad Pharma GmbH", "european_commission_decision_date": "13/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "10/05/2018", "last_updated_date": "13/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-tad" }, { "category": "Human", "name_of_medicine": "Actelsar HCT", "ema_product_number": "EMEA/H/C/002676", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000248682", "international_non_proprietary_name_common_name": "telmisartan;hydrochlorothiazide", "active_substance": "telmisartan;hydrochlorothiazide", "therapeutic_area_mesh": "Essential Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system;Angiotensin II antagonists and diuretics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "08/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/01/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/03/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "19/06/2018", "last_updated_date": "13/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/actelsar-hct" }, { "category": "Human", "name_of_medicine": "Xyrem", "ema_product_number": "EMEA/H/C/000593", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000268777", "international_non_proprietary_name_common_name": "sodium oxybate", "active_substance": "sodium oxybate", "therapeutic_area_mesh": "Cataplexy;Narcolepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of narcolepsy with cataplexy in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma Ltd", "european_commission_decision_date": "12/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/10/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "13/08/2018", "last_updated_date": "12/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xyrem" }, { "category": "Human", "name_of_medicine": "Olanzapine Teva", "ema_product_number": "EMEA/H/C/000810", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000256216", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V. ", "european_commission_decision_date": "12/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/12/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "19/02/2018", "last_updated_date": "12/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/olanzapine-teva" }, { "category": "Human", "name_of_medicine": "Omjjara", "ema_product_number": "EMEA/H/C/005768", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0004/G", "international_non_proprietary_name_common_name": "momelotinib", "active_substance": "Momelotinib dihydrochloride monohydrate", "therapeutic_area_mesh": "Splenomegaly;Myeloproliferative Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "ANTINEOPLASTIC AGENTS", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Omjjara is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "27/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/01/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "10/11/2023", "last_updated_date": "12/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/omjjara" }, { "category": "Human", "name_of_medicine": "Givlaari", "ema_product_number": "EMEA/H/C/004775", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000265950", "international_non_proprietary_name_common_name": "givosiran", "active_substance": "Givosiran", "therapeutic_area_mesh": "Porphyrias, Hepatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Various alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Alnylam Netherlands B.V.", "european_commission_decision_date": "08/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/03/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "09/03/2020", "last_updated_date": "08/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/givlaari" }, { "category": "Human", "name_of_medicine": "Tacforius", "ema_product_number": "EMEA/H/C/004435", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000266646", "international_non_proprietary_name_common_name": "tacrolimus", "active_substance": "tacrolimus monohydrate", "therapeutic_area_mesh": "Liver Transplantation;Kidney Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "08/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/10/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/12/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "08/12/2017", "last_updated_date": "08/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tacforius" }, { "category": "Human", "name_of_medicine": "Ongentys", "ema_product_number": "EMEA/H/C/002790", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2702", "international_non_proprietary_name_common_name": "opicapone", "active_substance": "opicapone", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bial - Portela Cª, S.A.", "european_commission_decision_date": "11/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/04/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/06/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "17/01/2017", "last_updated_date": "07/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ongentys" }, { "category": "Human", "name_of_medicine": "Evenity", "ema_product_number": "EMEA/H/C/004465", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000268076", "international_non_proprietary_name_common_name": "romosozumab", "active_substance": "romosozumab", "therapeutic_area_mesh": "Osteoporosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Evenity is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma S.A.", "european_commission_decision_date": "06/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "24/02/2020", "last_updated_date": "07/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evenity" }, { "category": "Human", "name_of_medicine": "Vectibix", "ema_product_number": "EMEA/H/C/000741", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0105", "international_non_proprietary_name_common_name": "panitumumab", "active_substance": "panitumumab", "therapeutic_area_mesh": "Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): in first-line in combination with Folfox or Folfiri. in second-line in combination with Folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "13/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/12/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "04/06/2018", "last_updated_date": "07/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vectibix" }, { "category": "Human", "name_of_medicine": "Daurismo", "ema_product_number": "EMEA/H/C/004878", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0015", "international_non_proprietary_name_common_name": "glasdegib", "active_substance": "Glasdegib maleate", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX63", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "31/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/04/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/06/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "10/07/2020", "last_updated_date": "07/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/daurismo" }, { "category": "Human", "name_of_medicine": "Urorec", "ema_product_number": "EMEA/H/C/001092", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000268274", "international_non_proprietary_name_common_name": "silodosin", "active_substance": "silodosin", "therapeutic_area_mesh": "Prostatic Hyperplasia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04CA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Ireland Ltd", "european_commission_decision_date": "06/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/01/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "12/04/2018", "last_updated_date": "07/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/urorec" }, { "category": "Human", "name_of_medicine": "Sitagliptin / Metformin hydrochloride Sun", "ema_product_number": "EMEA/H/C/005778", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000263136", "international_non_proprietary_name_common_name": "sitagliptin;metformin hydrochloride", "active_substance": "sitagliptin fumarate;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin hydrochloride SUN is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Sitagliptin/Metformin hydrochloride SUN is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Sitagliptin/Metformin hydrochloride SUN is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR? agonist. Sitagliptin/Metformin hydrochloride SUN is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "11/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/01/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/03/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "24/01/2023", "last_updated_date": "06/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-metformin-hydrochloride-sun" }, { "category": "Human", "name_of_medicine": "Posaconazole Accord", "ema_product_number": "EMEA/H/C/005005", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000267279", "international_non_proprietary_name_common_name": "posaconazole", "active_substance": "posaconazole", "therapeutic_area_mesh": "Mycoses", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults: Invasive aspergillosis; Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients:  Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "05/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/05/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/07/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "28/08/2019", "last_updated_date": "06/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/posaconazole-accord" }, { "category": "Human", "name_of_medicine": "Arsenic trioxide Mylan", "ema_product_number": "EMEA/H/C/005235", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0013/G", "international_non_proprietary_name_common_name": "arsenic trioxide", "active_substance": "arsenic trioxide", "therapeutic_area_mesh": "Leukemia, Promyelocytic, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Arsenic trioxide Mylan is indicated for induction of remission, and consolidation in adult patients with:- Newly diagnosed low to intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 103/?l) in combination with all trans retinoic acid (ATRA)- Relapsed/refractory acute promyelocytic leukaemia (APL) (Previous treatment should have included a retinoid and chemotherapy)characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic acid receptor alpha (PML/RAR alpha) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not beenexamined.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Ireland Limited", "european_commission_decision_date": "14/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/04/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "14/04/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "17/04/2020", "last_updated_date": "06/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/arsenic-trioxide-mylan" }, { "category": "Human", "name_of_medicine": "Ketoconazole Esteve (previously Ketoconazole HRA)", "ema_product_number": "EMEA/H/C/003906", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000248405", "international_non_proprietary_name_common_name": "ketoconazole", "active_substance": "Ketoconazole", "therapeutic_area_mesh": "Cushing Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ketoconazole Esteve is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.", "accelerated_assessment": "Yes", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Esteve Pharmaceuticals, S.A.", "european_commission_decision_date": "04/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/11/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "22/08/2017", "last_updated_date": "05/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ketoconazole-esteve" }, { "category": "Human", "name_of_medicine": "Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan)", "ema_product_number": "EMEA/H/C/004996", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000268788", "international_non_proprietary_name_common_name": "clopidogrel;acetylsalicylic acid", "active_substance": "acetylsalicylic acid;clopidogrel hydrogen sulfate", "therapeutic_area_mesh": "Acute Coronary Syndrome;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC30", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": " Clopidogrel/Acetylsalicylic acid Viatris is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Viatris is a fixed-dose combination medicinal product for continuation of therapy in: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention - ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "02/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "24/01/2020", "last_updated_date": "05/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-viatris" }, { "category": "Human", "name_of_medicine": "Ecansya (previously Capecitabine Krka)", "ema_product_number": "EMEA/H/C/002605", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00000531/202404", "international_non_proprietary_name_common_name": "capecitabine", "active_substance": "capecitabine", "therapeutic_area_mesh": "Colonic Neoplasms;Breast Neoplasms;Colorectal Neoplasms;Stomach Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Ecansya is indicated for the treatment of metastatic colorectal cancer. Ecansya is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Ecansya in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Ecansya is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "04/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/04/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "09/12/2016", "last_updated_date": "05/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ecansya" }, { "category": "Human", "name_of_medicine": "Capecitabine Accord", "ema_product_number": "EMEA/H/C/002386", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00000531/202404", "international_non_proprietary_name_common_name": "capecitabine", "active_substance": "capecitabine", "therapeutic_area_mesh": "Colonic Neoplasms;Breast Neoplasms;Colorectal Neoplasms;Stomach Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Capecitabine Accord is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine Accord is indicated for the treatment of metastatic colorectal cancer. Capecitabine Accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine Accord in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine Accord is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "04/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/04/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "09/01/2017", "last_updated_date": "05/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/capecitabine-accord" }, { "category": "Human", "name_of_medicine": "NeoRecormon", "ema_product_number": "EMEA/H/C/000116", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000262770", "international_non_proprietary_name_common_name": "epoetin beta", "active_substance": "epoetin beta", "therapeutic_area_mesh": "Kidney Failure, Chronic;Anemia;Cancer;Blood Transfusion, Autologous", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients; treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy; increasing the yield of autologous blood from patients in a pre-donation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "01/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/10/1996", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/07/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "09/08/2018", "last_updated_date": "02/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neorecormon" }, { "category": "Human", "name_of_medicine": "Capecitabine Medac", "ema_product_number": "EMEA/H/C/002568", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00000531/202404", "international_non_proprietary_name_common_name": "capecitabine", "active_substance": "capecitabine", "therapeutic_area_mesh": "Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine Medac is indicated for the treatment of metastatic colorectal cancer. Capecitabine Medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine Medac in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine Medac is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "european_commission_decision_date": "28/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "16/06/2017", "last_updated_date": "02/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/capecitabine-medac" }, { "category": "Human", "name_of_medicine": "Xeloda", "ema_product_number": "EMEA/H/C/000316", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00000531/202404", "international_non_proprietary_name_common_name": "capecitabine", "active_substance": "capecitabine", "therapeutic_area_mesh": "Colonic Neoplasms;Breast Neoplasms;Colorectal Neoplasms;Stomach Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer. Xeloda is indicated for the treatment of metastatic colorectal cancer. Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Xeloda in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Xeloda is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CHEPLAPHARM Arzneimittel GmbH", "european_commission_decision_date": "28/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/10/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/02/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "22/03/2018", "last_updated_date": "02/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xeloda" }, { "category": "Human", "name_of_medicine": "Eptifibatide Accord", "ema_product_number": "EMEA/H/C/004104", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000267275", "international_non_proprietary_name_common_name": "eptifibatide", "active_substance": "eptifibatide", "therapeutic_area_mesh": "Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin. Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes. Patients most likely to benefit from Eptifibatide Accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "02/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "11/01/2016", "last_updated_date": "02/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eptifibatide-accord" }, { "category": "Human", "name_of_medicine": "Alprolix", "ema_product_number": "EMEA/H/C/004142", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000262414", "international_non_proprietary_name_common_name": "eftrenonacog alfa", "active_substance": "eftrenonacog alfa", "therapeutic_area_mesh": "Hemophilia B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vitamin K and other hemostatics;Blood coagulation factors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Swedish Orphan Biovitrum AB (publ)", "european_commission_decision_date": "30/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/05/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "06/07/2018", "last_updated_date": "02/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alprolix" }, { "category": "Veterinary", "name_of_medicine": "Pirsue", "ema_product_number": "EMEA/V/C/000054", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pirlimycin", "active_substance": "pirlimycin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "02/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/pirsue" }, { "category": "Human", "name_of_medicine": "Extavia", "ema_product_number": "EMEA/H/C/000933", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0116/G", "international_non_proprietary_name_common_name": "interferon beta-1b", "active_substance": "interferon beta-1b", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Extavia is indicated for the treatment of: patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis; patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years; patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "08/12/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/03/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/05/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "25/04/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "14/06/2018", "last_updated_date": "30/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/extavia" }, { "category": "Human", "name_of_medicine": "Alofisel", "ema_product_number": "EMEA/H/C/004258", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0044/G", "international_non_proprietary_name_common_name": "darvadstrocel", "active_substance": "darvadstrocel", "therapeutic_area_mesh": "Rectal Fistula", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "14/09/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/03/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/12/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "08/05/2018", "last_updated_date": "29/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alofisel" }, { "category": "Human", "name_of_medicine": "Twynsta", "ema_product_number": "EMEA/H/C/001224", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000342548", "international_non_proprietary_name_common_name": "telmisartan;amlodipine", "active_substance": "telmisartan;amlodipine", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension in adults: Add-on therapy Twynsta is indicated in adults whose blood pressure is not adequately controlled on amlodipine. Replacement therapy Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "23/04/2026", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/10/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "22/05/2018", "last_updated_date": "28/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/twynsta" }, { "category": "Human", "name_of_medicine": "Alunbrig", "ema_product_number": "EMEA/H/C/004248", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0056", "international_non_proprietary_name_common_name": "brigatinib", "active_substance": "brigatinib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE43", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "13/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "26/11/2018", "last_updated_date": "25/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alunbrig" }, { "category": "Human", "name_of_medicine": "Elocta", "ema_product_number": "EMEA/H/C/003964", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000262312", "international_non_proprietary_name_common_name": "efmoroctocog alfa", "active_substance": "efmoroctocog alfa", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Elocta can be used for all age groups.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Swedish Orphan Biovitrum AB (publ)", "european_commission_decision_date": "25/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "30/01/2018", "last_updated_date": "25/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elocta" }, { "category": "Human", "name_of_medicine": "Dazluma", "ema_product_number": "EMEA/H/C/006068", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "troriluzole", "active_substance": "troriluzole hydrochloride monohydrate", "therapeutic_area_mesh": "Spinocerebellar Ataxias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with spinocerebellar ataxia genotype 3 (SCA3)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biohaven Bioscience Ireland Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "24/03/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/04/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dazluma" }, { "category": "Human", "name_of_medicine": "Regkirona", "ema_product_number": "EMEA/H/C/005854", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0016", "international_non_proprietary_name_common_name": "regdanvimab", "active_substance": "regdanvimab", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BD06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Regdanvimab is indicated for the treatment of adults with coronavirus disease 2019 (COVID-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "25/08/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/11/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/11/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "14/04/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "12/11/2021", "last_updated_date": "24/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/regkirona" }, { "category": "Human", "name_of_medicine": "Vevizye", "ema_product_number": "EMEA/H/C/006250", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000262160", "international_non_proprietary_name_common_name": "ciclosporin", "active_substance": "ciclosporin", "therapeutic_area_mesh": "Keratoconjunctivitis Sicca", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoires Théa", "european_commission_decision_date": "23/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "26/07/2024", "last_updated_date": "24/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vevizye" }, { "category": "Human", "name_of_medicine": "Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)", "ema_product_number": "EMEA/H/C/000211", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000242970 ", "international_non_proprietary_name_common_name": "telmisartan", "active_substance": "telmisartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "03/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/12/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "04/04/2018", "last_updated_date": "23/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kinzalmono" }, { "category": "Human", "name_of_medicine": "Pritor", "ema_product_number": "EMEA/H/C/000210", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000242970 ", "international_non_proprietary_name_common_name": "telmisartan", "active_substance": "telmisartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "03/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/12/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "13/04/2018", "last_updated_date": "23/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pritor" }, { "category": "Human", "name_of_medicine": "Evra", "ema_product_number": "EMEA/H/C/000410", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000263529", "international_non_proprietary_name_common_name": "norelgestromin;ethinyl estradiol", "active_substance": "norelgestromin;Ethinyl estradiol", "therapeutic_area_mesh": "Contraception", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Female contraception. Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "16/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "23/06/2017", "last_updated_date": "22/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evra" }, { "category": "Human", "name_of_medicine": "Elaprase", "ema_product_number": "EMEA/H/C/000700", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000263366", "international_non_proprietary_name_common_name": "idursulfase", "active_substance": "idursulfase", "therapeutic_area_mesh": "Mucopolysaccharidosis II", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland Branch", "european_commission_decision_date": "16/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "21/06/2018", "last_updated_date": "16/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elaprase" }, { "category": "Human", "name_of_medicine": "Tamiflu", "ema_product_number": "EMEA/H/C/000402", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000247267", "international_non_proprietary_name_common_name": "oseltamivir", "active_substance": "oseltamivir", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AH02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of influenza Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.Prevention of influenza Post-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. The appropriate use of Tamiflu for prevention of influenza should be determined on a case-by-case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older. Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic-influenza outbreak. Tamiflu is not a substitute for influenza vaccination. The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "15/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2002", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "43", "first_published_date": "09/08/2018", "last_updated_date": "15/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tamiflu" }, { "category": "Human", "name_of_medicine": "Inovelon", "ema_product_number": "EMEA/H/C/000660", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0067", "international_non_proprietary_name_common_name": "rufinamide", "active_substance": "rufinamide", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AF03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eisai GmbH", "european_commission_decision_date": "28/11/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "03/08/2018", "last_updated_date": "15/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/inovelon" }, { "category": "Human", "name_of_medicine": "Valdoxan", "ema_product_number": "EMEA/H/C/000915", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000265736 ", "international_non_proprietary_name_common_name": "agomelatine", "active_substance": "agomelatine", "therapeutic_area_mesh": "Depressive Disorder, Major", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of major depressive episodes in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "14/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/02/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "11/09/2017", "last_updated_date": "15/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/valdoxan" }, { "category": "Veterinary", "name_of_medicine": "Omeprazole TriviumVet", "ema_product_number": "EMEA/V/C/005345", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "omeprazole", "active_substance": "omeprazole", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Alimentary tract and metabolism;Drugs for acid related disorders;Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/02/2025", "last_updated_date": "15/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/omeprazole-triviumvet" }, { "category": "Veterinary", "name_of_medicine": "Elmaro", "ema_product_number": "EMEA/V/C/006389", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "maropitant", "active_substance": "Maropitant citrate monohydrate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Alimentary tract and metabolism;Other antiemetics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/02/2025", "last_updated_date": "15/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/elmaro" }, { "category": "Veterinary", "name_of_medicine": "Vectormune HVT-AIV", "ema_product_number": "EMEA/V/C/006288", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Avian influenza vaccine", "active_substance": "turkey herpesvirus, strain rHVT/AI-H5 (cell-associated), expressing haemagglutinin gene of Avian influenza subtype H5, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live viral vaccines;Domestic fowl", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/02/2025", "last_updated_date": "15/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vectormune-hvt-aiv" }, { "category": "Human", "name_of_medicine": "Mircera", "ema_product_number": "EMEA/H/C/000739", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0104/G", "international_non_proprietary_name_common_name": "methoxy polyethylene glycol-epoetin beta", "active_substance": "Methoxy polyethylene glycol-epoetin beta", "therapeutic_area_mesh": "Anemia;Kidney Failure, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1). Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "30/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/07/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "09/08/2018", "last_updated_date": "15/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mircera" }, { "category": "Human", "name_of_medicine": "Prometax", "ema_product_number": "EMEA/H/C/000255", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000263657", "international_non_proprietary_name_common_name": "rivastigmine", "active_substance": "rivastigmine", "therapeutic_area_mesh": "Alzheimer Disease;Parkinson Disease;Dementia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Almirall, S.A.", "european_commission_decision_date": "14/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/12/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "50", "first_published_date": "08/05/2018", "last_updated_date": "15/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prometax" }, { "category": "Human", "name_of_medicine": "Skojoy", "ema_product_number": "EMEA/H/C/006551", "medicine_status": "Application withdrawn", "opinion_status": "Positive", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Retinal Vein Occlusion;Choroidal Neovascularization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of age-related macular degeneration (AMD) and visual impairment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Technology (Ireland) UC", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2025", "withdrawal_of_application_date": "12/03/2025", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/01/2025", "last_updated_date": "14/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/skojoy" }, { "category": "Human", "name_of_medicine": "Cinqaero", "ema_product_number": "EMEA/H/C/003912", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000261646", "international_non_proprietary_name_common_name": "reslizumab", "active_substance": "reslizumab", "therapeutic_area_mesh": "Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03DX08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other systemic drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "11/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/06/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/08/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "14/12/2017", "last_updated_date": "11/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cinqaero" }, { "category": "Human", "name_of_medicine": "Edurant", "ema_product_number": "EMEA/H/C/002264", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000265340", "international_non_proprietary_name_common_name": "rilpivirine", "active_substance": "rilpivirine hydrochloride", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AG05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in paediatric patients 2 to less than 18 years of age and weighing at least 14 kg to less than 25 kg without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, and with a viral load ≤ 100,000 HIV 1 RNA copies/ml (see sections 4.4 and 5.1).Genotypic resistance testing should guide the use of EDURANT (see sections 4.4 and 5.1).EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults and paediatric patients weighing at least 25 kg without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, and with a viral load ≤ 100,000 HIV 1 RNA copies/ml (see sections 4.4 and 5.1).Genotypic resistance testing should guide the use of EDURANT (see sections 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.   ", "european_commission_decision_date": "11/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/11/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "08/05/2018", "last_updated_date": "11/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/edurant" }, { "category": "Human", "name_of_medicine": "Sialanar", "ema_product_number": "EMEA/H/C/003883", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0031/G", "international_non_proprietary_name_common_name": "glycopyrronium bromide", "active_substance": "glycopyrronium bromide", "therapeutic_area_mesh": "Sialorrhea", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A03AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for functional gastrointestinal disorders", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Proveca Pharma Limited", "european_commission_decision_date": "10/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "11/05/2017", "last_updated_date": "11/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sialanar" }, { "category": "Human", "name_of_medicine": "Moventig", "ema_product_number": "EMEA/H/C/002810", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA-10317-202409", "international_non_proprietary_name_common_name": "naloxegol", "active_substance": "naloxegol oxalate", "therapeutic_area_mesh": "Constipation;Opioid-Related Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A06AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Peripheral opioid receptor antagonists;Drugs for constipation", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Grunenthal GmbH", "european_commission_decision_date": "10/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/12/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "23/07/2018", "last_updated_date": "11/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/moventig" }, { "category": "Human", "name_of_medicine": "Relvar Ellipta", "ema_product_number": "EMEA/H/C/002673", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000247757", "international_non_proprietary_name_common_name": "fluticasone furoate;vilanterol", "active_substance": "fluticasone furoate;vilanterol", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Adrenergics and other drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Asthma indication: Relvar Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists. patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist. COPD indication: Relvar Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite bronchodilator therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "12/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/11/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "26/07/2018", "last_updated_date": "10/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/relvar-ellipta" }, { "category": "Human", "name_of_medicine": "Competact", "ema_product_number": "EMEA/H/C/000655", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000262689", "international_non_proprietary_name_common_name": "pioglitazone;metformin", "active_substance": "pioglitazone;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Competact is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CHEPLAPHARM Arzneimittel GmbH", "european_commission_decision_date": "08/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/07/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "12/12/2016", "last_updated_date": "09/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/competact" }, { "category": "Human", "name_of_medicine": "Quinsair", "ema_product_number": "EMEA/H/C/002789", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0039", "international_non_proprietary_name_common_name": "levofloxacin", "active_substance": "levofloxacin", "therapeutic_area_mesh": "Cystic Fibrosis;Respiratory Tract Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01MA12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A", "european_commission_decision_date": "01/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/12/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/03/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "07/06/2018", "last_updated_date": "09/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/quinsair" }, { "category": "Human", "name_of_medicine": "Rasagiline ratiopharm", "ema_product_number": "EMEA/H/C/003957", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000255892", "international_non_proprietary_name_common_name": "rasagiline", "active_substance": "rasagiline", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rasagiline ratiopharm is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "07/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/01/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "21/06/2018", "last_updated_date": "09/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rasagiline-ratiopharm" }, { "category": "Human", "name_of_medicine": "Kentera (previously Oxybutynin Nicobrand)", "ema_product_number": "EMEA/H/C/000532", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000255892", "international_non_proprietary_name_common_name": "oxybutynin", "active_substance": "oxybutynin", "therapeutic_area_mesh": "Urinary Incontinence, Urge", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V. ", "european_commission_decision_date": "07/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/06/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "03/05/2018", "last_updated_date": "08/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kentera" }, { "category": "Human", "name_of_medicine": "Azilect", "ema_product_number": "EMEA/H/C/000574", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000255892", "international_non_proprietary_name_common_name": "rasagiline", "active_substance": "rasagiline", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Azilect is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end-of-dose fluctuations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "07/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/08/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/02/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "21/06/2018", "last_updated_date": "08/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/azilect" }, { "category": "Human", "name_of_medicine": "Ajovy", "ema_product_number": "EMEA/H/C/004833", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0052", "international_non_proprietary_name_common_name": "fremanezumab", "active_substance": "fremanezumab", "therapeutic_area_mesh": "Migraine Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02CD03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcitonin gene-related peptide (CGRP) antagonists", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ajovy is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva GmbH", "european_commission_decision_date": "27/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/01/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/03/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "17/04/2019", "last_updated_date": "04/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ajovy" }, { "category": "Human", "name_of_medicine": "MabThera", "ema_product_number": "EMEA/H/C/000165", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000254621", "international_non_proprietary_name_common_name": "rituximab", "active_substance": "rituximab", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;Leukemia, Lymphocytic, Chronic, B-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "MabThera is indicated in adults for the following indications: Non Hodgkin’s lymphoma (NHL) MabThera is indicated for the treatment of previously untreated adult patients with stage III?IV follicular lymphoma in combination with chemotherapy. MabThera maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. MabThera monotherapy is indicated for treatment of adult patients with stage III?IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. MabThera is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non?Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. MabThera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ? 6 months  to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL). Chronic lymphocytic leukaemia (CLL) MabThera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy. Rheumatoid arthritis MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease?modifying anti?rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. MabThera has been shown to reduce the rate of progression of joint damage as measured by X?ray and to improve physical function, when given in combination with methotrexate. Granulomatosis with polyangiitis and microscopic polyangiitis MabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). MabThera, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ? 2 to < 18 years old) with severe, active GPA (Wegener’s) and MPA. Pemphigus vulgaris MabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "03/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/06/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "63", "first_published_date": "09/08/2018", "last_updated_date": "03/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mabthera" }, { "category": "Human", "name_of_medicine": "Litak", "ema_product_number": "EMEA/H/C/000504", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00000787/202402", "international_non_proprietary_name_common_name": "cladribine", "active_substance": "cladribine", "therapeutic_area_mesh": "Leukemia, Hairy Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Litak is indicated for the treatment of hairy-cell leukaemia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lipomed GmbH", "european_commission_decision_date": "19/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/04/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "07/03/2018", "last_updated_date": "03/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/litak" }, { "category": "Human", "name_of_medicine": "Yondelis", "ema_product_number": "EMEA/H/C/000773", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0070", "international_non_proprietary_name_common_name": "trabectedin", "active_substance": "trabectedin", "therapeutic_area_mesh": "Ovarian Neoplasms;Sarcoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Yondelis is indicated for the treatment of patients with advanced soft-tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharma Mar S.A.", "european_commission_decision_date": "13/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "25/06/2018", "last_updated_date": "03/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yondelis" }, { "category": "Human", "name_of_medicine": "Evista", "ema_product_number": "EMEA/H/C/000184", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000257013", "international_non_proprietary_name_common_name": "raloxifene", "active_substance": "raloxifene hydrochloride", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03XC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Evista is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Evista or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Substipharm", "european_commission_decision_date": "01/04/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/08/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "17/11/2017", "last_updated_date": "01/04/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evista" }, { "category": "Human", "name_of_medicine": "Ontilyv", "ema_product_number": "EMEA/H/C/005782", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2702", "international_non_proprietary_name_common_name": "opicapone", "active_substance": "opicapone", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04;N04BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ontilyv is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bial Portela & Companhia S.A.", "european_commission_decision_date": "11/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/02/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "21/02/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "14/12/2021", "last_updated_date": "28/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ontilyv" }, { "category": "Human", "name_of_medicine": "Nexavar", "ema_product_number": "EMEA/H/C/000690", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0059", "international_non_proprietary_name_common_name": "sorafenib", "active_substance": "sorafenib", "therapeutic_area_mesh": "Carcinoma, Hepatocellular;Carcinoma, Renal Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma. Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Differentiated thyroid carcinoma Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "13/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/07/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "25/06/2018", "last_updated_date": "28/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nexavar" }, { "category": "Human", "name_of_medicine": "Rolufta Ellipta (previously Rolufta)", "ema_product_number": "EMEA/H/C/004654", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2816", "international_non_proprietary_name_common_name": "umeclidinium", "active_substance": "umeclidinium bromide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03BB07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rolufta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "14/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/01/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/03/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "27/06/2018", "last_updated_date": "28/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rolufta-ellipta" }, { "category": "Human", "name_of_medicine": "Respreeza", "ema_product_number": "EMEA/H/C/002739", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000245783", "international_non_proprietary_name_common_name": "alpha1-proteinase inhibitor (human)", "active_substance": "human alpha1-proteinase inhibitor", "therapeutic_area_mesh": "Genetic Diseases, Inborn;Lung Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null,null), PiSZ). Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CSL Behring GmbH", "european_commission_decision_date": "26/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/08/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "22/02/2018", "last_updated_date": "27/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/respreeza" }, { "category": "Human", "name_of_medicine": "VeraSeal", "ema_product_number": "EMEA/H/C/004446", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000255532", "international_non_proprietary_name_common_name": "human fibrinogen;human thrombin", "active_substance": "human fibrinogen, human thrombin", "therapeutic_area_mesh": "Hemostasis, Surgical", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Supportive treatment in adults where standard surgical techniques are insufficient: for improvement of haemostasis as suture support in vascular surgery", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Instituto Grifols, S.A.", "european_commission_decision_date": "27/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "10/11/2017", "last_updated_date": "27/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/veraseal" }, { "category": "Human", "name_of_medicine": "Febuxostat Krka", "ema_product_number": "EMEA/H/C/004773", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000258495", "international_non_proprietary_name_common_name": "febuxostat", "active_substance": "febuxostat", "therapeutic_area_mesh": "Hyperuricemia;Gout", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M04AA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antigout preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Febuxostat Krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Krka is indicated in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "26/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/01/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/03/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "29/03/2019", "last_updated_date": "27/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/febuxostat-krka" }, { "category": "Human", "name_of_medicine": "Samsca", "ema_product_number": "EMEA/H/C/000980", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0051", "international_non_proprietary_name_common_name": "tolvaptan", "active_substance": "tolvaptan", "therapeutic_area_mesh": "Inappropriate ADH Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C03XA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diuretics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Otsuka Pharmaceutical Netherlands B.V.", "european_commission_decision_date": "13/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/05/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/08/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "29/06/2018", "last_updated_date": "26/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/samsca" }, { "category": "Human", "name_of_medicine": "Onpattro", "ema_product_number": "EMEA/H/C/004699", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000248933", "international_non_proprietary_name_common_name": "patisiran", "active_substance": "patisiran sodium", "therapeutic_area_mesh": "Amyloidosis, Familial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.", "accelerated_assessment": "Yes", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Alnylam Netherlands B.V.", "european_commission_decision_date": "24/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/08/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "27/07/2018", "last_updated_date": "25/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/onpattro" }, { "category": "Human", "name_of_medicine": "Buvidal", "ema_product_number": "EMEA/H/C/004651", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000258074", "international_non_proprietary_name_common_name": "buprenorphine", "active_substance": "buprenorphine", "therapeutic_area_mesh": "Opioid-Related Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07BC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Camurus AB", "european_commission_decision_date": "21/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "18/12/2018", "last_updated_date": "21/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/buvidal" }, { "category": "Human", "name_of_medicine": "Mycapssa", "ema_product_number": "EMEA/H/C/005826", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "octreotide", "active_substance": "octreotide acetate", "therapeutic_area_mesh": "Acromegaly", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01CB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amryt Pharmaceuticals DAC", "european_commission_decision_date": "02/12/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/12/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "26/02/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/12/2022", "last_updated_date": "21/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mycapssa" }, { "category": "Human", "name_of_medicine": "Sivextro", "ema_product_number": "EMEA/H/C/002846", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0054", "international_non_proprietary_name_common_name": "tedizolid phosphate", "active_substance": "tedizolid", "therapeutic_area_mesh": "Soft Tissue Infections;Skin Diseases, Bacterial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01XX11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use;Other antibacterials", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sivextro tablets are indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults, adolescents and children weighing at least 35 kg.Consideration should be given to official guidance on the appropriate use of antibacterial agents. Sivextro powder for concentrate for solution for infusion is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) from birth. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "28/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/01/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/03/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "08/08/2018", "last_updated_date": "20/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sivextro" }, { "category": "Human", "name_of_medicine": "Scintimun", "ema_product_number": "EMEA/H/C/001045", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000253479", "international_non_proprietary_name_common_name": "besilesomab", "active_substance": "besilesomab", "therapeutic_area_mesh": "Osteomyelitis;Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09HA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only and the approved indication is scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. Scintimun should not be used for the diagnosis of diabetic foot infection.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Telix Innovations", "european_commission_decision_date": "17/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "22/09/2016", "last_updated_date": "20/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/scintimun" }, { "category": "Human", "name_of_medicine": "Tenofovir disoproxil Zentiva", "ema_product_number": "EMEA/H/C/004120", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000256696", "international_non_proprietary_name_common_name": "tenofovir disoproxil", "active_substance": "tenofovir disoproxil phosphate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "HIV?1 infection Tenofovir disoproxil Zentiva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV?1 infected adults. In adults, the demonstration of the benefit of tenofovir disoproxil in HIV?1 infection is based on results of one study in treatment?naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre?treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml). Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV?1 infected adolescents, with NRTI (nucleotide reverse transcriptase inhibitor) resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. The choice of Tenofovir disoproxil Zentiva to treat antiretroviral?experienced patients with HIV?1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1); evidence of lamivudine-resistant hepatitis B virus (see sections 4.8 and 5.1); decompensated liver disease (see sections 4.4, 4.8 and 5.1). Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with: compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis (see sections 4.4, 4.8 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva k.s.", "european_commission_decision_date": "19/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "18/01/2018", "last_updated_date": "19/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tenofovir-disoproxil-zentiva" }, { "category": "Human", "name_of_medicine": "Emtricitabine/Tenofovir disoproxil Zentiva", "ema_product_number": "EMEA/H/C/004137", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000256683", "international_non_proprietary_name_common_name": "emtricitabine;tenofovir disoproxil", "active_substance": "emtricitabine;tenofovir disoproxil phosphate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of HIV-1 infection Emtricitabine/Tenofovir disoproxil Zentiva is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents. Pre-exposure prophylaxis (PrEP) Emtricitabine/Tenofovir disoproxil Zentiva is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva k.s.", "european_commission_decision_date": "18/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "13/10/2017", "last_updated_date": "19/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabine-tenofovir-disoproxil-zentiva" }, { "category": "Human", "name_of_medicine": "Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva", "ema_product_number": "EMEA/H/C/004250", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000256672", "international_non_proprietary_name_common_name": "efavirenz;emtricitabine;tenofovir disoproxil", "active_substance": "efavirenz;emtricitabine;tenofovir disoproxil phosphate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva prior to initiation of their first antiretroviral treatment regimen. The demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil. No data are currently available from clinical studies with combination efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients. No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva k.s.", "european_commission_decision_date": "18/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/05/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "09/01/2018", "last_updated_date": "18/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/efavirenz-emtricitabine-tenofovir-disoproxil-zentiva" }, { "category": "Human", "name_of_medicine": "Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)", "ema_product_number": "EMEA/H/C/004836", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0034", "international_non_proprietary_name_common_name": "beclometasone;formoterol", "active_substance": "formoterol fumarate dihydrate;glycopyrronium;beclometasone dipropionate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptoms control and prevention of exacerbations see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A.", "european_commission_decision_date": "04/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "06/03/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "23/04/2018", "last_updated_date": "18/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/riarify" }, { "category": "Veterinary", "name_of_medicine": "Leucofeligen FeLV/RCP", "ema_product_number": "EMEA/V/C/000143", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "feline calicivirosis, feline viral rhinotrachieitis, feline infectious enteritis (feline panleucopenia) vaccine (live), feline leukaemia vaccine (inactivated)", "active_substance": "purified p45 feline leukaemia virus envelope antigen;live feline calicivirus (strain F9);live feline viral rhinotracheitis virus (strain F2);live feline panleucopenia virus", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for felidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/12/2016", "last_updated_date": "17/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/leucofeligen-felv-rcp" }, { "category": "Veterinary", "name_of_medicine": "Cimalgex", "ema_product_number": "EMEA/V/C/000162", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "cimicoxib", "active_substance": "cimicoxib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "07/01/2016", "last_updated_date": "17/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cimalgex" }, { "category": "Veterinary", "name_of_medicine": "Cytopoint", "ema_product_number": "EMEA/V/C/003939", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "lokivetmab", "active_substance": "lokivetmab", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Other dermatological preparations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/01/2018", "last_updated_date": "17/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cytopoint" }, { "category": "Human", "name_of_medicine": "Skilarence", "ema_product_number": "EMEA/H/C/002157", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000251714", "international_non_proprietary_name_common_name": "dimethyl fumarate", "active_substance": "dimethyl fumarate", "therapeutic_area_mesh": "Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Almirall, S.A.", "european_commission_decision_date": "17/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/04/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/06/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "20/06/2018", "last_updated_date": "17/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/skilarence" }, { "category": "Human", "name_of_medicine": "Revinty Ellipta", "ema_product_number": "EMEA/H/C/002745", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000247760", "international_non_proprietary_name_common_name": "fluticasone furoate;vilanterol", "active_substance": "fluticasone furoate;vilanterol trifenatate", "therapeutic_area_mesh": "Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Adrenergics and other drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Asthma Indication Revinty Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists. COPD Indication Revinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite bronchodilator therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "12/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/03/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/05/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "21/08/2018", "last_updated_date": "14/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/revinty-ellipta" }, { "category": "Veterinary", "name_of_medicine": "Prevexxion RN", "ema_product_number": "EMEA/V/C/005058", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Marek's disease vaccine (live recombinant)", "active_substance": "Live recombinant Marek’s disease (MD) virus, serotype 1, strain RN1250", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Avian herpes virus (marek's disease)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/04/2021", "last_updated_date": "14/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/prevexxion-rn" }, { "category": "Veterinary", "name_of_medicine": "Mhyosphere PCV ID", "ema_product_number": "EMEA/V/C/005272", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Mycoplasma hyopneumoniae and porcine circovirus vaccine (inactivated, recombinant)", "active_substance": "Mycoplasma hyopneumoniae, strain 7304 (Nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated viral and inactivated bacterial vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/02/2021", "last_updated_date": "14/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/mhyosphere-pcv-id" }, { "category": "Veterinary", "name_of_medicine": "Porcilis PCV", "ema_product_number": "EMEA/V/C/000135", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "adjuvanted inactivated vaccine against porcine circovirus", "active_substance": "porcine circovirus type 2 ORF2 subunit antigen", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/02/2017", "last_updated_date": "14/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/porcilis-pcv" }, { "category": "Human", "name_of_medicine": "Silodyx", "ema_product_number": "EMEA/H/C/001209", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000255291", "international_non_proprietary_name_common_name": "silodosin", "active_substance": "silodosin", "therapeutic_area_mesh": "Prostatic Hyperplasia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04CA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Ireland Ltd", "european_commission_decision_date": "10/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/01/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "12/04/2018", "last_updated_date": "14/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/silodyx" }, { "category": "Human", "name_of_medicine": "Gencebok", "ema_product_number": "EMEA/H/C/005435", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0012", "international_non_proprietary_name_common_name": "caffeine citrate", "active_substance": "Caffeine citrate", "therapeutic_area_mesh": "Apnea", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06BC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of primary apnoea of premature newborns.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gennisium Pharma", "european_commission_decision_date": "07/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/08/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "27/08/2020", "last_updated_date": "12/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gencebok" }, { "category": "Human", "name_of_medicine": "Paxneury", "ema_product_number": "EMEA/H/C/006312", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "guanfacine", "active_substance": "guanfacine hydrochloride", "therapeutic_area_mesh": "Attention Deficit Disorder with Hyperactivity", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02AC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Paxneury is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6‑17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Paxneury must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Neuraxpharm Pharmaceuticals S.L.", "european_commission_decision_date": "26/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/12/2024", "last_updated_date": "11/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/paxneury" }, { "category": "Human", "name_of_medicine": "Andembry", "ema_product_number": "EMEA/H/C/006116", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "garadacimab", "active_substance": "garadacimab", "therapeutic_area_mesh": "Angioedemas, Hereditary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Andembry is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CSL Behring GmbH", "european_commission_decision_date": "10/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/12/2024", "last_updated_date": "11/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/andembry" }, { "category": "Human", "name_of_medicine": "Emcitate", "ema_product_number": "EMEA/H/C/005220", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tiratricol", "active_substance": "tiratricol", "therapeutic_area_mesh": "Thyrotoxicosis;Heredodegenerative Disorders, Nervous System", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H03AA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Thyroid therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Emcitate is indicated for the treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley Syndrome), from birth.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Rare Thyroid Therapeutics International AB", "european_commission_decision_date": "12/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/02/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/12/2024", "last_updated_date": "11/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emcitate" }, { "category": "Human", "name_of_medicine": "Inaqovi", "ema_product_number": "EMEA/H/C/005823", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000247810", "international_non_proprietary_name_common_name": "cedazuridine;decitabine", "active_substance": "cedazuridine;decitabine", "therapeutic_area_mesh": "Leukemia, Myeloid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC58", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Otsuka Pharmaceutical Netherlands B.V.", "european_commission_decision_date": "10/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "21/07/2023", "last_updated_date": "10/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/inaqovi" }, { "category": "Human", "name_of_medicine": "Sutent", "ema_product_number": "EMEA/H/C/000687", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000255150", "international_non_proprietary_name_common_name": "sunitinib", "active_substance": "sunitinib", "therapeutic_area_mesh": "Gastrointestinal Stromal Tumors;Carcinoma, Renal Cell;Neuroendocrine Tumors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Gastrointestinal stromal tumour (GIST) Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. Experience with Sutent as first-line treatment is limited (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "10/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/07/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "41", "first_published_date": "22/02/2018", "last_updated_date": "10/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sutent" }, { "category": "Human", "name_of_medicine": "Silodosin Recordati", "ema_product_number": "EMEA/H/C/004964", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000255260", "international_non_proprietary_name_common_name": "silodosin", "active_substance": "silodosin", "therapeutic_area_mesh": "Prostatic Hyperplasia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04CA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals;Alpha-adrenoreceptor antagonists", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Ireland Ltd", "european_commission_decision_date": "10/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/01/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "22/01/2019", "last_updated_date": "10/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/silodosin-recordati" }, { "category": "Human", "name_of_medicine": "BeneFIX", "ema_product_number": "EMEA/H/C/000139", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000252321", "international_non_proprietary_name_common_name": "nonacog alfa", "active_substance": "nonacog alfa", "therapeutic_area_mesh": "Hemophilia B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor-IX deficiency).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "06/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/08/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "43", "first_published_date": "26/06/2017", "last_updated_date": "07/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/benefix" }, { "category": "Veterinary", "name_of_medicine": "Nobilis Multriva REOm", "ema_product_number": "EMEA/V/C/006501", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian reovirus vaccine (inactivated)", "active_substance": "inactivated avian reovirus strain ARV-1;inactivated avian reovirus strain ARV-4", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/01/2025", "last_updated_date": "07/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-multriva-reom" }, { "category": "Veterinary", "name_of_medicine": "Equilis Prequenza", "ema_product_number": "EMEA/V/C/000094", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "vaccine against equine influenza in horses", "active_substance": "equine influenza-virus strains: A/equine-2/South Africa/4/03, A/equine-2/Newmarket/2/93", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "equine influenza virus", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/04/2013", "last_updated_date": "07/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/equilis-prequenza" }, { "category": "Veterinary", "name_of_medicine": "Equilis Te", "ema_product_number": "EMEA/V/C/000093", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "adjuvanted vaccine against tetanus", "active_substance": "tetanus toxoid", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for equidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/09/2016", "last_updated_date": "07/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/equilis-te" }, { "category": "Veterinary", "name_of_medicine": "Equilis Prequenza Te", "ema_product_number": "EMEA/V/C/000095", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "vaccine against equine influenza and tetanus in horses", "active_substance": "equine influenza-virus strains: A/equine-2/South Africa/4/03, A/equine-2/Newmarket/2/93, tetanus toxoid", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "equine influenza virus + clostridium", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/09/2016", "last_updated_date": "07/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/equilis-prequenza-te" }, { "category": "Human", "name_of_medicine": "Dynastat", "ema_product_number": "EMEA/H/C/000381", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000248141", "international_non_proprietary_name_common_name": "parecoxib", "active_substance": "parecoxib sodium", "therapeutic_area_mesh": "Pain, Postoperative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M01AH04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiinflammatory and antirheumatic products;Coxibs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the short-term treatment of postoperative pain in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "04/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/03/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "21/06/2018", "last_updated_date": "05/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dynastat" }, { "category": "Human", "name_of_medicine": "Quofenix", "ema_product_number": "EMEA/H/C/004860", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0030", "international_non_proprietary_name_common_name": "delafloxacin", "active_substance": "delafloxacin meglumine", "therapeutic_area_mesh": "Community-Acquired Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01MA23", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Quofenix is indicated for the treatment of the following infections in adults: acute bacterial skin and skin structure infections (ABSSSI), community-acquired pneumonia (CAP), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "A. Menarini Industrie Farmaceutiche Riunite s.r.l.", "european_commission_decision_date": "25/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/12/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "20/12/2019", "last_updated_date": "05/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/quofenix" }, { "category": "Veterinary", "name_of_medicine": "Bluevac-3", "ema_product_number": "EMEA/V/C/006575", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bluetongue virus vaccine (inactivated)", "active_substance": "inactivated bluetongue virus, serotype 3", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Ovidae;Immunologicals for Bovidae;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/01/2025", "last_updated_date": "05/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bluevac-3" }, { "category": "Human", "name_of_medicine": "Tarceva", "ema_product_number": "EMEA/H/C/000618", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000256063", "international_non_proprietary_name_common_name": "erlotinib", "active_substance": "erlotinib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Pancreatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Non-small cell lung cancer (NSCLC) Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours. Pancreatic cancer Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer. When prescribing Tarceva, factors associated with prolonged survival should be taken into account.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cheplapharm Registration GmbH", "european_commission_decision_date": "04/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "09/08/2018", "last_updated_date": "05/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tarceva" }, { "category": "Human", "name_of_medicine": "ReFacto AF", "ema_product_number": "EMEA/H/C/000232", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000255442", "international_non_proprietary_name_common_name": "moroctocog alfa", "active_substance": "moroctocog alfa", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). ReFacto AF is appropriate for use in adults and children of all ages, including newborns. ReFacto AF does not contain von-Willebrand factor, and hence is not indicated in von-Willebrand's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "03/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/04/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "41", "first_published_date": "02/08/2018", "last_updated_date": "05/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/refacto-af" }, { "category": "Human", "name_of_medicine": "Toviaz", "ema_product_number": "EMEA/H/C/000723", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000256192", "international_non_proprietary_name_common_name": "fesoterodine", "active_substance": "fesoterodine fumarate", "therapeutic_area_mesh": "Urinary Bladder, Overactive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BD11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of the symptoms (increased urinary frequency and / or urgency and / or urgency incontinence) that may occur in patients with overactive-bladder syndrome.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "03/03/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/04/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "30/07/2018", "last_updated_date": "04/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/toviaz" }, { "category": "Human", "name_of_medicine": "Ryzodeg", "ema_product_number": "EMEA/H/C/002499", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0047/G", "international_non_proprietary_name_common_name": "insulin degludec;insulin aspart", "active_substance": "insulin aspart;insulin degludec", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AD06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "15/02/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/01/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "12/10/2017", "last_updated_date": "04/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ryzodeg" }, { "category": "Human", "name_of_medicine": "Mirvaso", "ema_product_number": "EMEA/H/C/002642", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0039", "international_non_proprietary_name_common_name": "brimonidine", "active_substance": "brimonidine tartrate", "therapeutic_area_mesh": "Skin Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D11AX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other dermatological preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Galderma International", "european_commission_decision_date": "11/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/02/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "26/04/2018", "last_updated_date": "04/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mirvaso" }, { "category": "Human", "name_of_medicine": "Nepexto", "ema_product_number": "EMEA/H/C/004711", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0033", "international_non_proprietary_name_common_name": "etanercept", "active_substance": "etanercept", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Arthritis, Psoriatic;Spondylarthropathies;Spondylitis, Ankylosing;Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Nepexto in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Nepexto can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.  Nepexto is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Nepexto, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Etanercept has not been studied in children aged less than 2 years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biosimilar Collaborations Ireland Limited", "european_commission_decision_date": "12/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/03/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/05/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "04/06/2020", "last_updated_date": "03/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nepexto" }, { "category": "Human", "name_of_medicine": "Spherox", "ema_product_number": "EMEA/H/C/002736", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000255173", "international_non_proprietary_name_common_name": "spheroids of human autologous matrix-associated chondrocytes", "active_substance": "spheroids of human autologous matrix-associated chondrocytes", "therapeutic_area_mesh": "Cartilage Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Repair Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CO.DON Gmbh", "european_commission_decision_date": "27/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/05/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "26/04/2018", "last_updated_date": "03/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/spherox" }, { "category": "Human", "name_of_medicine": "Litfulo", "ema_product_number": "EMEA/H/C/006025", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000245562", "international_non_proprietary_name_common_name": "ritlecitinib", "active_substance": "ritlecitinib tosilate", "therapeutic_area_mesh": "Alopecia Areata", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AF08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "26/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "17/07/2023", "last_updated_date": "03/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/litfulo" }, { "category": "Human", "name_of_medicine": "Modigraf", "ema_product_number": "EMEA/H/C/000954", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00002839/202403", "international_non_proprietary_name_common_name": "tacrolimus", "active_substance": "tacrolimus", "therapeutic_area_mesh": "Graft Rejection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma Europe B.V.", "european_commission_decision_date": "12/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/05/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "17/05/2018", "last_updated_date": "03/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/modigraf" }, { "category": "Human", "name_of_medicine": "Torisel", "ema_product_number": "EMEA/H/C/000799", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000246449", "international_non_proprietary_name_common_name": "temsirolimus", "active_substance": "temsirolimus", "therapeutic_area_mesh": "Carcinoma, Renal Cell;Lymphoma, Mantle-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Renal-cell carcinoma Torisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors. Mantle-cell lymphoma Torisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "25/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "08/08/2018", "last_updated_date": "03/03/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/torisel" }, { "category": "Human", "name_of_medicine": "Envarsus", "ema_product_number": "EMEA/H/C/002655", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00002839/202403", "international_non_proprietary_name_common_name": "tacrolimus", "active_substance": "tacrolimus", "therapeutic_area_mesh": "Graft Rejection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici S.p.A.", "european_commission_decision_date": "12/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/07/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "05/05/2017", "last_updated_date": "28/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/envarsus" }, { "category": "Human", "name_of_medicine": "Advagraf", "ema_product_number": "EMEA/H/C/000712", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00002839/202403", "international_non_proprietary_name_common_name": "tacrolimus", "active_substance": "tacrolimus", "therapeutic_area_mesh": "Graft Rejection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma Europe BV", "european_commission_decision_date": "12/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "17/05/2018", "last_updated_date": "27/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/advagraf" }, { "category": "Human", "name_of_medicine": "Fasenra", "ema_product_number": "EMEA/H/C/004433", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0054", "international_non_proprietary_name_common_name": "benralizumab", "active_substance": "Benralizumab", "therapeutic_area_mesh": "Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03DX10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "AsthmaFasenra is indicated as an add on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long acting β agonists (see section 5.1).Eosinophilic granulomatosis with polyangiitis (EGPA)Fasenra is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "13/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "28/02/2018", "last_updated_date": "27/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fasenra" }, { "category": "Human", "name_of_medicine": "Somavert", "ema_product_number": "EMEA/H/C/000409", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000254772", "international_non_proprietary_name_common_name": "pegvisomant", "active_substance": "pegvisomant", "therapeutic_area_mesh": "Acromegaly", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01AX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated. Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF -I concentrations or was not tolerated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "25/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2002", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/11/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "23/08/2018", "last_updated_date": "27/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/somavert" }, { "category": "Human", "name_of_medicine": "GeGant", "ema_product_number": "EMEA/H/C/005165", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "germanium (68Ge) chloride;gallium (68Ga) chloride", "active_substance": "gallium (68Ga) chloride;germanium (68Ge) chloride", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated for in vitro labelling of kits for radiopharmaceutical preparation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ITM Medical Isotopes GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "15/04/2024", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/04/2024", "last_updated_date": "26/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gegant" }, { "category": "Human", "name_of_medicine": "Aripiprazole Accord", "ema_product_number": "EMEA/H/C/004021", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000254891", "international_non_proprietary_name_common_name": "aripiprazole", "active_substance": "aripiprazole", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "24/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "15/02/2018", "last_updated_date": "26/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aripiprazole-accord" }, { "category": "Human", "name_of_medicine": "Brimica Genuair", "ema_product_number": "EMEA/H/C/003969", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "SW/0044", "international_non_proprietary_name_common_name": "aclidinium;formoterol fumarate dihydrate", "active_substance": "formoterol fumarate dihydrate;aclidinium bromide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Brimica Genuair is indicated as a maintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Covis Pharma Europe B.V.", "european_commission_decision_date": "20/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "18/05/2018", "last_updated_date": "25/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/brimica-genuair" }, { "category": "Human", "name_of_medicine": "Bretaris Genuair", "ema_product_number": "EMEA/H/C/002706", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "SW/0057", "international_non_proprietary_name_common_name": "aclidinium bromide", "active_substance": "aclidinium bromide", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03BB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Covis Pharma Europe B.V.", "european_commission_decision_date": "20/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/07/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "18/05/2018", "last_updated_date": "25/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bretaris-genuair" }, { "category": "Veterinary", "name_of_medicine": "Poulvac Procerta HVT-IBD-ND", "ema_product_number": "EMEA/V/C/006306", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "turkey herpes virus, strain HVT-IBD-ND, expressing the VP2 protein of IBDV and the F protein of NDV, live recombinant", "active_substance": "Live recombinant turkey herpes virus, strain HVT-IBD-ND, expressing the VP2 protein of IBDV and the F protein of NDV", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI01AD16", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live viral vaccines;avian herpes virus (marek's disease) + avian infectious bursal disease virus (gumboro disease) + newcastle disease virus/paramyxovirus", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/12/2024", "last_updated_date": "24/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/poulvac-procerta-hvt-ibd-nd" }, { "category": "Veterinary", "name_of_medicine": "Icthiovac ERM", "ema_product_number": "EMEA/V/C/006309", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated vaccine against yersiniosis", "active_substance": "inactivated vaccine against yersiniosis", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI10AB04", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Atlantic salmon;Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "06/12/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/12/2024", "last_updated_date": "24/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/icthiovac-erm" }, { "category": "Human", "name_of_medicine": "Zoely", "ema_product_number": "EMEA/H/C/001213", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00002182/202401", "international_non_proprietary_name_common_name": "nomegestrol;estradiol", "active_substance": "nomegestrol acetate;estradiol", "therapeutic_area_mesh": "Contraception", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03AA14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Oral contraception", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Theramex Ireland Limited", "european_commission_decision_date": "14/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "12/07/2018", "last_updated_date": "19/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zoely" }, { "category": "Human", "name_of_medicine": "Apretude", "ema_product_number": "EMEA/H/C/005756", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00000116/202403", "international_non_proprietary_name_common_name": "cabotegravir", "active_substance": "cabotegravir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AJ04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare B.V.", "european_commission_decision_date": "09/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "17/07/2023", "last_updated_date": "19/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/apretude" }, { "category": "Human", "name_of_medicine": "Thyrogen", "ema_product_number": "EMEA/H/C/000220", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0000236228", "international_non_proprietary_name_common_name": "thyrotropin alfa", "active_substance": "thyrotropin alfa", "therapeutic_area_mesh": "Thyroid Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anterior pituitary lobe hormones and analogues;Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (THST).   Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels.  Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi B.V.", "european_commission_decision_date": "13/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/03/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "30/01/2018", "last_updated_date": "19/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/thyrogen" }, { "category": "Human", "name_of_medicine": "Galvus", "ema_product_number": "EMEA/H/C/000771", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000240310", "international_non_proprietary_name_common_name": "vildagliptin", "active_substance": "vildagliptin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BH02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "28/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/07/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/09/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "26/04/2018", "last_updated_date": "19/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/galvus" }, { "category": "Human", "name_of_medicine": "Blenrep", "ema_product_number": "EMEA/H/C/004935", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "R/017", "international_non_proprietary_name_common_name": "belantamab mafodotin", "active_substance": "belantamab mafodotin", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC39", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "23/02/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/08/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "23/02/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "17/09/2020", "last_updated_date": "19/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep1" }, { "category": "Human", "name_of_medicine": "GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.)", "ema_product_number": "EMEA/H/C/004882", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0016", "international_non_proprietary_name_common_name": "budesonide;formoterol fumarate dihydrate", "active_substance": "Budesonide;formoterol fumarate dihydrate", "therapeutic_area_mesh": "Asthma;Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only. Asthma Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. or -in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. COPD Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V. ", "european_commission_decision_date": "10/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/04/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "07/04/2020", "last_updated_date": "18/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/goresp-digihaler" }, { "category": "Human", "name_of_medicine": "Opfolda", "ema_product_number": "EMEA/H/C/005695", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0010/G", "international_non_proprietary_name_common_name": "miglustat", "active_substance": "miglustat", "therapeutic_area_mesh": "Glycogen Storage Disease Type II", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset Pompe disease (acid ?- glucosidase [GAA] deficiency).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amicus Therapeutics Europe Limited", "european_commission_decision_date": "24/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/06/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "24/04/2023", "last_updated_date": "14/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opfolda" }, { "category": "Human", "name_of_medicine": "Bortezomib Fresenius Kabi", "ema_product_number": "EMEA/H/C/005074", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000244627", "international_non_proprietary_name_common_name": "bortezomib", "active_substance": "bortezomib", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "13/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "25/11/2019", "last_updated_date": "13/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bortezomib-fresenius-kabi" }, { "category": "Human", "name_of_medicine": "Docetaxel Accord", "ema_product_number": "EMEA/H/C/002539", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000246935", "international_non_proprietary_name_common_name": "docetaxel", "active_substance": "docetaxel", "therapeutic_area_mesh": "Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "04/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/03/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/05/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "18/06/2018", "last_updated_date": "13/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/docetaxel-accord" }, { "category": "Human", "name_of_medicine": "Dimethyl fumarate Neuraxpharm", "ema_product_number": "EMEA/H/C/006500", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000246862", "international_non_proprietary_name_common_name": "dimethyl fumarate", "active_substance": "dimethyl fumarate", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dimethyl fumarate Neuraxpharm is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Neuraxpharm Pharmaceuticals S.L.", "european_commission_decision_date": "12/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "11/07/2024", "last_updated_date": "13/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-neuraxpharm" }, { "category": "Human", "name_of_medicine": "Nimenrix", "ema_product_number": "EMEA/H/C/002226", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000248574", "international_non_proprietary_name_common_name": "meningococcal groups A, C, W-135 and Y conjugate vaccine", "active_substance": "Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid", "therapeutic_area_mesh": "Meningitis, Meningococcal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AH08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "12/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/02/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/04/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "41", "first_published_date": "15/03/2018", "last_updated_date": "13/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nimenrix" }, { "category": "Human", "name_of_medicine": "Skytrofa (previously Lonapegsomatropin Ascendis Pharma)", "ema_product_number": "EMEA/H/C/005367", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0036", "international_non_proprietary_name_common_name": "lonapegsomatropin", "active_substance": "Lonapegsomatropin", "therapeutic_area_mesh": "Growth and Development", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01AC09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD])", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ascendis Pharma Endocrinology Division A/S", "european_commission_decision_date": "22/05/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/11/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "10/11/2021", "last_updated_date": "12/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/skytrofa" }, { "category": "Human", "name_of_medicine": "Pemetrexed Fresenius Kabi", "ema_product_number": "EMEA/H/C/003895", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00002330/202402", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Mesothelioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Malignant pleural mesothelioma Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Fresenius Kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Fresenius Kabi is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "19/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/05/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/07/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "06/07/2018", "last_updated_date": "12/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-fresenius-kabi" }, { "category": "Human", "name_of_medicine": "Repaglinide Teva", "ema_product_number": "EMEA/H/C/001067", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000248206", "international_non_proprietary_name_common_name": "repaglinide", "active_substance": "repaglinide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2-diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "11/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/06/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "25/05/2016", "last_updated_date": "11/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/repaglinide-teva" }, { "category": "Veterinary", "name_of_medicine": "Tolfenamic acid VMD", "ema_product_number": "EMEA/V/C/006234", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tolfenamic acid", "active_substance": "tolfenamic acid", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products, non-steroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/12/2024", "last_updated_date": "06/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/tolfenamic-acid-vmd" }, { "category": "Human", "name_of_medicine": "Vumerity", "ema_product_number": "EMEA/H/C/005437", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0019", "international_non_proprietary_name_common_name": "diroximel fumarate", "active_substance": "Diroximel fumarate (BIIB098)", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see Section 5.1 for important information on the populations for which efficacy has been established).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biogen Netherlands B.V.", "european_commission_decision_date": "04/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "14/09/2021", "last_updated_date": "05/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vumerity" }, { "category": "Human", "name_of_medicine": "Penbraya", "ema_product_number": "EMEA/H/C/006165", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meningococcal groups A, C, W, Y conjugate and group B vaccine (recombinant, adsorbed)", "active_substance": "Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group W polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group B fHBP protein subfamily A;Neisseria meningitidis group B fHBP protein subfamily B", "therapeutic_area_mesh": "Meningitis, Meningococcal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AH11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines, meningococcal vaccines ", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Penbraya is indicated for active immunisation of individuals 10 years of age and older to prevent invasive disease caused by Neisseria meningitidis groups A, B, C, W, and Y. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "20/01/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/09/2024", "last_updated_date": "05/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/penbraya" }, { "category": "Human", "name_of_medicine": "Emtricitabine/Tenofovir disoproxil Krka d.d.", "ema_product_number": "EMEA/H/C/004686", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000242563", "international_non_proprietary_name_common_name": "emtricitabine;tenofovir disoproxil", "active_substance": "emtricitabine;tenofovir disoproxil succinate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Emtricitabine/Tenofovir disoproxil Krka d.d. is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Krka d.d. is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "KRKA, d.d., Novo mesto", "european_commission_decision_date": "31/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/04/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "25/07/2018", "last_updated_date": "05/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabine-tenofovir-disoproxil-krka-dd" }, { "category": "Human", "name_of_medicine": "Enyglid", "ema_product_number": "EMEA/H/C/001065", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000242537", "international_non_proprietary_name_common_name": "repaglinide", "active_substance": "repaglinide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "27/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "24/06/2016", "last_updated_date": "05/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enyglid" }, { "category": "Human", "name_of_medicine": "Repaglinide Krka", "ema_product_number": "EMEA/H/C/001066", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000242547", "international_non_proprietary_name_common_name": "repaglinide", "active_substance": "repaglinide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "03/02/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/11/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "27/10/2017", "last_updated_date": "04/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/repaglinide-krka" }, { "category": "Human", "name_of_medicine": "Izelvay", "ema_product_number": "EMEA/H/C/006153", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avacincaptad pegol", "active_substance": "avacincaptad pegol", "therapeutic_area_mesh": "Macular Degeneration;Geographic Atrophy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA32", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated for the treatment of adults with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma Europe B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "24/10/2024", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/11/2024", "last_updated_date": "04/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/izelvay" }, { "category": "Human", "name_of_medicine": "Fortacin", "ema_product_number": "EMEA/H/C/002693", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0040", "international_non_proprietary_name_common_name": "lidocaine;prilocaine", "active_substance": "lidocaine;prilocaine", "therapeutic_area_mesh": "Sexual Dysfunction, Physiological", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N01BB20", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anesthetics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of primary premature ejaculation in adult men.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Ireland Ltd.", "european_commission_decision_date": "31/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "25/11/2013", "last_updated_date": "03/02/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fortacin" }, { "category": "Human", "name_of_medicine": "Emtricitabine/Tenofovir disoproxil Krka", "ema_product_number": "EMEA/H/C/004215", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000242560", "international_non_proprietary_name_common_name": "emtricitabine;tenofovir disoproxil", "active_substance": "emtricitabine;tenofovir disoproxil succinate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of HIV-1 infection Emtricitabine/tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Krka is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years (see section 5.1 Pre-exposure prophylaxis (PrEP) Emtricitabine/Tenofovir disoproxil Krka is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "KRKA, d.d., Novo mesto", "european_commission_decision_date": "31/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "25/07/2018", "last_updated_date": "31/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabine-tenofovir-disoproxil-krka" }, { "category": "Human", "name_of_medicine": "Tavneos", "ema_product_number": "EMEA/H/C/005523", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010967/202403", "international_non_proprietary_name_common_name": "avacopan", "active_substance": "avacopan", "therapeutic_area_mesh": "Microscopic Polyangiitis;Wegener Granulomatosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Vifor Fresenius Medical Care Renal Pharma France", "european_commission_decision_date": "15/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/11/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "10/11/2021", "last_updated_date": "31/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tavneos" }, { "category": "Veterinary", "name_of_medicine": "Carprofen Orion", "ema_product_number": "EMEA/V/C/006249", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "carprofen", "active_substance": "carprofen", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Musculo-skeletal system;Anti-inflammatory and anti-rheumatic products, non-steroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/11/2024", "last_updated_date": "31/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/carprofen-orion" }, { "category": "Human", "name_of_medicine": "Nugalviq", "ema_product_number": "EMEA/H/C/006270", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "govorestat", "active_substance": "govorestat", "therapeutic_area_mesh": "Galactosemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX24", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Various alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adults and children aged 2 years and older with a confirmed diagnosis of classic galactosemia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Advanz Pharma Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "10/12/2024", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/01/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nugalviq" }, { "category": "Veterinary", "name_of_medicine": "Neocolipor", "ema_product_number": "EMEA/V/C/000035", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "neonatal piglet colibacillosis vaccine (inactivated)", "active_substance": "E. coli adhesin F4 (F4ab, F4ac, F4ad);E. coli adhesin F5;E. coli adhesin F6;E. coli adhesin F41", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/12/2014", "last_updated_date": "31/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/neocolipor" }, { "category": "Human", "name_of_medicine": "Celldemic", "ema_product_number": "EMEA/H/C/006052", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2707", "international_non_proprietary_name_common_name": "zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)", "active_substance": "Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Celldemic is indicated for active immunisation against H5N1 subtype of Influenza A virus in adults and infants from 6 months of age and above. Celldemic should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Seqirus Netherlands B.V.", "european_commission_decision_date": "14/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "23/02/2024", "last_updated_date": "29/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/celldemic" }, { "category": "Human", "name_of_medicine": "Edarbi", "ema_product_number": "EMEA/H/C/002293", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000246998", "international_non_proprietary_name_common_name": "azilsartan medoxomil", "active_substance": "azilsartan medoxomil", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Edarbi is indicated for the treatment of essential hypertension in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "29/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/09/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/12/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "20/03/2018", "last_updated_date": "29/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/edarbi" }, { "category": "Human", "name_of_medicine": "Augtyro", "ema_product_number": "EMEA/H/C/006005", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "repotrectinib", "active_substance": "repotrectinib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX28", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Augtyro as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). Augtyro as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or  have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "13/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/01/2025", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/11/2024", "last_updated_date": "28/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/augtyro" }, { "category": "Human", "name_of_medicine": "Telmisartan Actavis", "ema_product_number": "EMEA/H/C/001168", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000245919", "international_non_proprietary_name_common_name": "telmisartan", "active_substance": "telmisartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type 2 diabetes mellitus with documented target organ damage.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "28/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/06/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/09/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "21/08/2018", "last_updated_date": "28/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/telmisartan-actavis" }, { "category": "Human", "name_of_medicine": "Darunavir Krka", "ema_product_number": "EMEA/H/C/004273", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000241954", "international_non_proprietary_name_common_name": "darunavir", "active_substance": "darunavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "400 and 800 mg Darunavir Krka, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir Krka 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART)-naïve (see section 4.2). ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ? 100 cells x 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1). 600 mg Darunavir Krka, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir Krka 600 mg tablets may be used to provide suitable dose regimens (see section 4.2): For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated. For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "KRKA, d.d., Novo mesto", "european_commission_decision_date": "17/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/01/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "13/06/2018", "last_updated_date": "28/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/darunavir-krka" }, { "category": "Human", "name_of_medicine": "Sitagliptin Accord", "ema_product_number": "EMEA/H/C/005598", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0003/G", "international_non_proprietary_name_common_name": "sitagliptin", "active_substance": "sitagliptin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For adult patients with type 2 diabetes mellitus, Sitagliptin Accord is indicated to improve glycaemic control: as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (PPARy) agonist (i.e. a thiazolidinedione) when use of a PPARy agonist is appropriate and when diet and exercise plus the PPARy agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a PPARy agonist and metformin when use of a PPARy agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin Accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "24/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/04/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "22/02/2022", "last_updated_date": "27/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-accord" }, { "category": "Human", "name_of_medicine": "Lojuxta", "ema_product_number": "EMEA/H/C/002578", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000244756", "international_non_proprietary_name_common_name": "lomitapide", "active_substance": "Lomitapide", "therapeutic_area_mesh": "Hypercholesterolemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lojuxta is indicated as an adjunct to a low?fat diet and other lipid?lowering medicinal products with or without low-density-lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinaemia and secondary causes of hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici SpA", "european_commission_decision_date": "27/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/07/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "27/08/2018", "last_updated_date": "27/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lojuxta" }, { "category": "Human", "name_of_medicine": "Izba", "ema_product_number": "EMEA/H/C/002738", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000245405", "international_non_proprietary_name_common_name": "travoprost", "active_substance": "travoprost", "therapeutic_area_mesh": "Ocular Hypertension;Glaucoma, Open-Angle", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01EE04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals;Antiglaucoma preparations and miotics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1). Decrease of elevated intraocular pressure in paediatric patients aged 3 years to < 18 years with ocular hypertension or paediatric glaucoma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "22/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/02/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "15/02/2018", "last_updated_date": "27/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/izba" }, { "category": "Human", "name_of_medicine": "Renagel", "ema_product_number": "EMEA/H/C/000254", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0123", "international_non_proprietary_name_common_name": "sevelamer", "active_substance": "sevelamer", "therapeutic_area_mesh": "Renal Dialysis;Hyperphosphatemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AE02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Renagel is indicated for the control of hyperphosphataemia in adult patients receiving  haemodialysis or peritoneal dialysis. Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "13/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/01/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "38", "first_published_date": "15/12/2017", "last_updated_date": "22/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/renagel" }, { "category": "Human", "name_of_medicine": "Levodopa/Carbidopa/Entacapone Orion", "ema_product_number": "EMEA/H/C/002441", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0041", "international_non_proprietary_name_common_name": "levodopa;carbidopa;entacapone", "active_substance": "levodopa;carbidopa;entacapone", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Nervous system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Orion Corporation", "european_commission_decision_date": "21/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "08/02/2018", "last_updated_date": "22/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levodopa-carbidopa-entacapone-orion" }, { "category": "Human", "name_of_medicine": "Skycovion", "ema_product_number": "EMEA/H/C/005998", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "GBP510", "active_substance": "GBP510", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SK Chemicals GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "01/09/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/09/2023", "last_updated_date": "22/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/skycovion" }, { "category": "Human", "name_of_medicine": "Masitinib AB Science", "ema_product_number": "EMEA/H/C/005897", "medicine_status": "Refused", "opinion_status": "Negative", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "masitinib", "active_substance": "Masitinib mesilate", "therapeutic_area_mesh": "Amyotrophic Lateral Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "In combination with riluzole for the treatment of adult patients with amyotrophic lateral sclerosis (ALS)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AB Science", "european_commission_decision_date": "19/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "19/12/2024", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/06/2024", "last_updated_date": "22/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/masitinib-ab-science" }, { "category": "Human", "name_of_medicine": "Inlyta", "ema_product_number": "EMEA/H/C/002406", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000245212", "international_non_proprietary_name_common_name": "axitinib", "active_substance": "axitinib", "therapeutic_area_mesh": "Carcinoma, Renal Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EK01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "21/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/05/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/09/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "03/08/2018", "last_updated_date": "22/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/inlyta" }, { "category": "Human", "name_of_medicine": "Thalidomide BMS (previously Thalidomide Celgene)", "ema_product_number": "EMEA/H/C/000823", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0080", "international_non_proprietary_name_common_name": "thalidomide", "active_substance": "thalidomide", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "21/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/04/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "08/08/2018", "last_updated_date": "22/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/thalidomide-bms" }, { "category": "Human", "name_of_medicine": "Efavirenz/Emtricitabine/Tenofovir disoproxil Krka", "ema_product_number": "EMEA/H/C/004274", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000241468", "international_non_proprietary_name_common_name": "efavirenz;emtricitabine;tenofovir disoproxil", "active_substance": "efavirenz;emtricitabine;tenofovir disoproxil succinate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Krka prior to initiation of their first antiretroviral treatment regimen. The demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil. No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients. No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "KRKA, d.d., Novo mesto", "european_commission_decision_date": "16/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/02/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "08/02/2018", "last_updated_date": "22/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/efavirenz-emtricitabine-tenofovir-disoproxil-krka" }, { "category": "Human", "name_of_medicine": "Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma)", "ema_product_number": "EMEA/H/C/005922", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0005/G", "international_non_proprietary_name_common_name": "dabigatran etexilate", "active_substance": "dabigatran etexilate mesilate", "therapeutic_area_mesh": "Venous Thromboembolism;Arthroplasty, Replacement", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AE07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dabigatran etexilate Leon Farma 75 mg Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age. Dabigatran etexilate Leon Farma 110 mg Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age. Dabigatran etexilate Leon Farma 150 mg Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults Treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva GmbH", "european_commission_decision_date": "20/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/02/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "12/12/2023", "last_updated_date": "21/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dabigatran-etexilate-teva" }, { "category": "Human", "name_of_medicine": "Posaconazole AHCL", "ema_product_number": "EMEA/H/C/005028", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000244236", "international_non_proprietary_name_common_name": "posaconazole", "active_substance": "posaconazole", "therapeutic_area_mesh": "Mycoses", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Posaconazole AHCL oral suspension is indicated for use in the treatment of the following fungal infections in adults: Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole AHCL oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients: Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "16/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/05/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/07/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "28/08/2019", "last_updated_date": "21/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/posaconazole-ahcl" }, { "category": "Human", "name_of_medicine": "Potactasol", "ema_product_number": "EMEA/H/C/002282", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0022", "international_non_proprietary_name_common_name": "topotecan", "active_substance": "topotecan", "therapeutic_area_mesh": "Uterine Cervical Neoplasms;Small Cell Lung Carcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy- patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "17/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/10/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/01/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "20/03/2018", "last_updated_date": "20/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/potactasol" }, { "category": "Human", "name_of_medicine": "Levitra", "ema_product_number": "EMEA/H/C/000475", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00003098/202403", "international_non_proprietary_name_common_name": "vardenafil", "active_substance": "vardenafil", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Levitra to be effective, sexual stimulation is required. Levitra is not indicated for use by women.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG ", "european_commission_decision_date": "13/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/03/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "19/04/2018", "last_updated_date": "20/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levitra" }, { "category": "Human", "name_of_medicine": "Ocaliva", "ema_product_number": "EMEA/H/C/004093", "medicine_status": "Revoked", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0048", "international_non_proprietary_name_common_name": "obeticholic acid", "active_substance": "obeticholic acid", "therapeutic_area_mesh": "Liver Cirrhosis, Biliary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A05AA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bile and liver therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Advanz Pharma Limited", "european_commission_decision_date": "16/04/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/12/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "30/08/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "21/03/2018", "last_updated_date": "20/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ocaliva" }, { "category": "Human", "name_of_medicine": "Gavreto", "ema_product_number": "EMEA/H/C/005413", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0021", "international_non_proprietary_name_common_name": "pralsetinib", "active_substance": "pralsetinib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX23", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Blueprint Medicines (Netherlands) B.V.", "european_commission_decision_date": "17/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/11/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "24/10/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "14/09/2021", "last_updated_date": "17/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gavreto" }, { "category": "Human", "name_of_medicine": "Kinzalkomb", "ema_product_number": "EMEA/H/C/000415", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG1812", "international_non_proprietary_name_common_name": "telmisartan;hydrochlorothiazide", "active_substance": "telmisartan;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. Kinzalkomb fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone. Kinzalkomb fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "07/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "41", "first_published_date": "12/04/2018", "last_updated_date": "17/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kinzalkomb" }, { "category": "Human", "name_of_medicine": "PritorPlus", "ema_product_number": "EMEA/H/C/000414", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG1812", "international_non_proprietary_name_common_name": "telmisartan;hydrochlorothiazide", "active_substance": "telmisartan;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. PritorPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone. PritorPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on PritorPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "07/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/04/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "13/04/2018", "last_updated_date": "17/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pritorplus" }, { "category": "Human", "name_of_medicine": "Pravafenix", "ema_product_number": "EMEA/H/C/001243", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0037", "international_non_proprietary_name_common_name": "fenofibrate;pravastatin", "active_substance": "fenofibrate;pravastatin", "therapeutic_area_mesh": "Dyslipidemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10BA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pravafenix is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the treatment of mixed hyperlipidaemia in adult patients at high cardiovascular risk to reduce triglycerides and increase HDL C when LDL C levels are adequately controlled while on a treatment with pravastatin 40 mg monotherapy or on another moderate-intensity statin regimen.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoires SMB S.A.", "european_commission_decision_date": "21/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/04/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "14/01/2016", "last_updated_date": "17/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pravafenix" }, { "category": "Human", "name_of_medicine": "Pheburane", "ema_product_number": "EMEA/H/C/002500", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0041", "international_non_proprietary_name_common_name": "sodium phenylbutyrate", "active_substance": "sodium phenylbutyrate", "therapeutic_area_mesh": "Carbamoyl-Phosphate Synthase I Deficiency Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Various alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of chronic management of urea-cycle disorders.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eurocept International B. V.", "european_commission_decision_date": "17/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/02/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/07/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "20/07/2017", "last_updated_date": "14/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pheburane" }, { "category": "Human", "name_of_medicine": "Pepaxti", "ema_product_number": "EMEA/H/C/005681", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0015", "international_non_proprietary_name_common_name": "melphalan flufenamide", "active_substance": "Melphalan flufenamide hydrochloride", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AA10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Oncopeptides AB (publ)", "european_commission_decision_date": "09/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/08/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "21/06/2022", "last_updated_date": "13/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pepaxti" }, { "category": "Veterinary", "name_of_medicine": "Previcox", "ema_product_number": "EMEA/V/C/000082", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "firocoxib", "active_substance": "firocoxib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "05/12/2014", "last_updated_date": "10/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/previcox" }, { "category": "Human", "name_of_medicine": "PreHevbri", "ema_product_number": "EMEA/H/C/005466", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0008", "international_non_proprietary_name_common_name": "hepatitis B surface antigen", "active_substance": "hepatitis B surface antigen", "therapeutic_area_mesh": "Hepatitis B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "PreHevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis B virus in adults. It can be expected that hepatitis D will also be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. The use of PreHevbri should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "VBI Vaccines B.V.", "european_commission_decision_date": "25/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/04/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "22/02/2022", "last_updated_date": "10/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prehevbri" }, { "category": "Veterinary", "name_of_medicine": "Dany's BienenWohl", "ema_product_number": "EMEA/V/C/004667", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "oxalic acid dihydrate", "active_substance": "oxalic acid dihydrate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/06/2018", "last_updated_date": "10/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/danys-bienenwohl" }, { "category": "Veterinary", "name_of_medicine": "Oxybee", "ema_product_number": "EMEA/V/C/004296", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "oxalic acid dehydrate", "active_substance": "oxalic acid dihydrate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/02/2018", "last_updated_date": "10/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/oxybee" }, { "category": "Human", "name_of_medicine": "Epixram", "ema_product_number": "EMEA/H/C/006186", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "levetiracetam", "active_substance": "", "therapeutic_area_mesh": "Epilepsy;Epilepsy, Generalized;Myoclonic Epilepsy, Juvenile", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of partial onset seizures.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Neuraxpharm Pharmaceuticals S.L.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "19/09/2024", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/10/2024", "last_updated_date": "09/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/epixram" }, { "category": "Human", "name_of_medicine": "GONAL-f", "ema_product_number": "EMEA/H/C/000071", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0176/G", "international_non_proprietary_name_common_name": "follitropin alfa", "active_substance": "follitropin alfa", "therapeutic_area_mesh": "Anovulation;Reproductive Techniques, Assisted;Infertility, Female;Hypogonadism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03GA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate. Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in-vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT). GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/l. GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Europe B.V.", "european_commission_decision_date": "06/01/2025", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/10/1995", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "03/08/2018", "last_updated_date": "09/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gonal-f" }, { "category": "Human", "name_of_medicine": "Renvela", "ema_product_number": "EMEA/H/C/000993", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0066", "international_non_proprietary_name_common_name": "sevelamer carbonate", "active_substance": "sevelamer carbonate", "therapeutic_area_mesh": "Hyperphosphatemia;Renal Dialysis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AE02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ? 1.78 mmol/l. Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "19/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/03/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/06/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "22/02/2018", "last_updated_date": "08/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/renvela" }, { "category": "Veterinary", "name_of_medicine": "Vaxxon ND Clone", "ema_product_number": "EMEA/V/C/006296", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Newcastle disease virus, strain clone, live attenuated", "active_substance": "Newcastle disease virus, strain Clone, live attenuated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Live viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/10/2024", "last_updated_date": "08/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vaxxon-nd-clone" }, { "category": "Veterinary", "name_of_medicine": "Duotic", "ema_product_number": "EMEA/V/C/006102", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "betamethasone acetate;terbinafine", "active_substance": "betamethasone acetate;terbinafine", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Sensory organs;Otologicals;Corticosteroids and antiinfectives in combination", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/10/2024", "last_updated_date": "08/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/duotic" }, { "category": "Human", "name_of_medicine": "Tecfidera", "ema_product_number": "EMEA/H/C/002601", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0088", "international_non_proprietary_name_common_name": "dimethyl fumarate", "active_substance": "dimethyl fumarate", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biogen Netherlands B.V.", "european_commission_decision_date": "18/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/01/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "09/11/2017", "last_updated_date": "06/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tecfidera" }, { "category": "Human", "name_of_medicine": "Apremilast Viatris", "ema_product_number": "EMEA/H/C/006193", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "apremilast", "active_substance": "apremilast", "therapeutic_area_mesh": "Arthritis, Psoriatic;Psoriasis;Behcet Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA32", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of psoriatic arthritis, psoriasis, Behçet’s disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/09/2024", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/10/2024", "last_updated_date": "06/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/apremilast-viatris" }, { "category": "Human", "name_of_medicine": "Stalevo", "ema_product_number": "EMEA/H/C/000511", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0102", "international_non_proprietary_name_common_name": "levodopa;carbidopa;entacapone", "active_substance": "levodopa;carbidopa;entacapone", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Orion Corporation", "european_commission_decision_date": "12/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/10/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "08/02/2018", "last_updated_date": "06/01/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/stalevo" }, { "category": "Veterinary", "name_of_medicine": "Nobivac L4", "ema_product_number": "EMEA/V/C/002010", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "canine leptospirosis vaccine (inactivated)", "active_substance": "Leptospira interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000);L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001);L. interrogans serogroup Australis serovar Bratislava (strain As-05-073);L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/07/2017", "last_updated_date": "19/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobivac-l4" }, { "category": "Veterinary", "name_of_medicine": "Versican Plus DHPPi", "ema_product_number": "EMEA/V/C/003679", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus", "active_substance": "canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B and canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "19/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/versican-plus-dhppi" }, { "category": "Veterinary", "name_of_medicine": "Versican Plus DHPPi/L4", "ema_product_number": "EMEA/V/C/003678", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "live, attenuated Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus inactivated", "active_substance": "canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B, canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091...", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "19/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/versican-plus-dhppi-l4" }, { "category": "Human", "name_of_medicine": "Idelvion", "ema_product_number": "EMEA/H/C/003955", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0076", "international_non_proprietary_name_common_name": "albutrepenonacog alfa", "active_substance": "albutrepenonacog alfa", "therapeutic_area_mesh": "Hemophilia B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CSL Behring GmbH", "european_commission_decision_date": "17/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/02/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/05/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "21/12/2017", "last_updated_date": "19/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/idelvion" }, { "category": "Veterinary", "name_of_medicine": "Purevax RCP FeLV", "ema_product_number": "EMEA/V/C/000089", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia", "active_substance": "attenuated feline rhinotracheitis herpesvirus (FHV F2 strain);inactivated feline calicivirosis antigens (FCV 431 and G1 strains);attenuated feline panleucopenia virus (PLI IV);FeLV recombinant canarypox virus (vCP97)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for felidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "05/05/2015", "last_updated_date": "19/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/purevax-rcp-felv" }, { "category": "Veterinary", "name_of_medicine": "Purevax RCP", "ema_product_number": "EMEA/V/C/000090", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia", "active_substance": "attenuated feline panleucopenia virus (PLI IV)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for felidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/01/2015", "last_updated_date": "19/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/purevax-rcp" }, { "category": "Veterinary", "name_of_medicine": "Purevax FeLV", "ema_product_number": "EMEA/V/C/000056", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "vaccine against feline leukaemia", "active_substance": "feline leukaemia virus recombinant canarypox virus (vCP97)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for felidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/05/2014", "last_updated_date": "19/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/purevax-felv" }, { "category": "Human", "name_of_medicine": "Zyprexa Velotab", "ema_product_number": "EMEA/H/C/000287", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0103/G", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CHEPLAPHARM Registration GmbH", "european_commission_decision_date": "16/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/10/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/02/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "23/02/2017", "last_updated_date": "18/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zyprexa-velotab" }, { "category": "Human", "name_of_medicine": "Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)", "ema_product_number": "EMEA/H/C/003971", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0038", "international_non_proprietary_name_common_name": "sevelamer carbonate", "active_substance": "sevelamer carbonate", "therapeutic_area_mesh": "Hyperphosphatemia;Renal Dialysis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AE02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L. Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "12/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/01/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "25/07/2018", "last_updated_date": "18/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sevelamer-carbonate-winthrop" }, { "category": "Human", "name_of_medicine": "Voncento", "ema_product_number": "EMEA/H/C/002493", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0066", "international_non_proprietary_name_common_name": "human coagulation factor VIII / human von willebrand factor", "active_substance": "human coagulation factor VIII;human von willebrand factor", "therapeutic_area_mesh": "Hemophilia A;von Willebrand Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Blood coagulation factors;von Willebrand factor and coagulation factor VIII in combination;Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Von Willebrand disease (VWD) Prophylaxis and treatment of haemorrhage or surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. Haemophilia A (congenital factor-VIII deficiency) Prophylaxis and treatment of bleeding in patients with haemophilia A.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CSL Behring GmbH", "european_commission_decision_date": "17/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/08/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "26/04/2018", "last_updated_date": "18/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/voncento" }, { "category": "Human", "name_of_medicine": "Firdapse (previously Zenas)", "ema_product_number": "EMEA/H/C/001032", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "S/0071", "international_non_proprietary_name_common_name": "amifampridine", "active_substance": "amifampridine", "therapeutic_area_mesh": "Lambert-Eaton Myasthenic Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SERB SA", "european_commission_decision_date": "22/07/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/10/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/12/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "13/07/2018", "last_updated_date": "18/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/firdapse" }, { "category": "Human", "name_of_medicine": "Signifor", "ema_product_number": "EMEA/H/C/002052", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0072/G", "international_non_proprietary_name_common_name": "pasireotide", "active_substance": "pasireotide", "therapeutic_area_mesh": "Acromegaly;Pituitary ACTH Hypersecretion", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01CB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Signifor is indicated for the treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. Signifor is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Rare Diseases", "european_commission_decision_date": "16/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/04/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "12/04/2018", "last_updated_date": "18/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/signifor" }, { "category": "Human", "name_of_medicine": "Wilzin", "ema_product_number": "EMEA/H/C/000535", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0036/G", "international_non_proprietary_name_common_name": "zinc", "active_substance": "zinc", "therapeutic_area_mesh": "Hepatolenticular Degeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Wilson's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Rare Diseases", "european_commission_decision_date": "16/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/10/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "14/02/2017", "last_updated_date": "18/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/wilzin" }, { "category": "Human", "name_of_medicine": "Vizimpro", "ema_product_number": "EMEA/H/C/004779", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0012", "international_non_proprietary_name_common_name": "dacomitinib", "active_substance": "dacomitinib monohydrate", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EB07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "11/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/01/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/04/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "05/06/2019", "last_updated_date": "17/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vizimpro" }, { "category": "Human", "name_of_medicine": "Durysta", "ema_product_number": "EMEA/H/C/005916", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bimatoprost", "active_substance": "bimatoprost", "therapeutic_area_mesh": "Glaucoma, Open-Angle;Ocular Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01EE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated for the reduction of intraocular pressure (IOP) in adults with open angle glaucoma (OAG) or ocular hypertension (OHT) who are unsuitable for topical IOP-lowering medications.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/09/2024", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/09/2024", "last_updated_date": "17/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/durysta" }, { "category": "Human", "name_of_medicine": "Naglazyme", "ema_product_number": "EMEA/H/C/000640", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0097", "international_non_proprietary_name_common_name": "galsulfase", "active_substance": "galsulfase", "therapeutic_area_mesh": "Mucopolysaccharidosis VI", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Naglazyme is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine-4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1). As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease. A key issue is to treat young patients aged <5 years suffering from a severe form of the disease, even though patients <5 years were not included in the pivotal phase-3 study.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioMarin International Limited", "european_commission_decision_date": "12/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/01/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "13/07/2018", "last_updated_date": "16/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/naglazyme" }, { "category": "Human", "name_of_medicine": "Vedrop", "ema_product_number": "EMEA/H/C/000920", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0052/G", "international_non_proprietary_name_common_name": "tocofersolan", "active_substance": "tocofersolan", "therapeutic_area_mesh": "Cholestasis;Vitamin E Deficiency", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A11HA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vitamins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vedrop is indicated in vitamin-E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Rare Diseases", "european_commission_decision_date": "10/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "24/07/2018", "last_updated_date": "16/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vedrop" }, { "category": "Human", "name_of_medicine": "Bamlanivimab and etesevimab for COVID-19", "ema_product_number": "EMEA/H/C/005836", "medicine_status": "Withdrawn from rolling review", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "bamlanivimab;Etesevimab", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "11/03/2021", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "02/11/2021", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "29/10/2021", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "02/11/2021", "last_updated_date": "13/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bamlanivimab-etesevimab-covid-19" }, { "category": "Human", "name_of_medicine": "Ledaga", "ema_product_number": "EMEA/H/C/002826", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0040", "international_non_proprietary_name_common_name": "chlormethine", "active_substance": "chlormethine", "therapeutic_area_mesh": "Mycosis Fungoides", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Helsinn Birex Pharmaceuticals Ltd.", "european_commission_decision_date": "11/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/03/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "20/11/2017", "last_updated_date": "12/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ledaga" }, { "category": "Human", "name_of_medicine": "Cystadane", "ema_product_number": "EMEA/H/C/000678", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0042/G", "international_non_proprietary_name_common_name": "betaine anhydrous", "active_substance": "Betaine anhydrous", "therapeutic_area_mesh": "Homocystinuria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adjunctive treatment of homocystinuria, involving deficiencies or defects in: cystathionine beta-synthase (CBS); 5,10-methylene-tetrahydrofolate reductase (MTHFR); cobalamin cofactor metabolism (cbl). Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Rare Diseases", "european_commission_decision_date": "10/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "24/07/2018", "last_updated_date": "12/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cystadane" }, { "category": "Human", "name_of_medicine": "Isturisa", "ema_product_number": "EMEA/H/C/004821", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0024/G", "international_non_proprietary_name_common_name": "osilodrostat", "active_substance": "osilodrostat phosphate", "therapeutic_area_mesh": "Cushing Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H02CA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Corticosteroids for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Isturisa is indicated for the treatment of endogenous Cushing’s syndrome in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Rare Diseases", "european_commission_decision_date": "18/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/11/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "18/02/2020", "last_updated_date": "12/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/isturisa" }, { "category": "Human", "name_of_medicine": "Cystagon", "ema_product_number": "EMEA/H/C/000125", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0074/G", "international_non_proprietary_name_common_name": "mercaptamine bitartrate", "active_substance": "mercaptamine bitartrate", "therapeutic_area_mesh": "Cystinosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cystagon is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Rare Diseases", "european_commission_decision_date": "10/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/06/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "24/07/2018", "last_updated_date": "11/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cystagon" }, { "category": "Human", "name_of_medicine": "Alli (previously Orlistat GSK)", "ema_product_number": "EMEA/H/C/000854", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0074", "international_non_proprietary_name_common_name": "orlistat", "active_substance": "orlistat", "therapeutic_area_mesh": "Obesity", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A08AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiobesity preparations, excl. diet products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Alli is indicated for weight loss in adults who are overweight (body mass index, BMI, 28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Haleon Ireland Dungarvan Limited", "european_commission_decision_date": "04/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/05/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/07/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "29/06/2017", "last_updated_date": "05/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alli" }, { "category": "Human", "name_of_medicine": "Esperoct", "ema_product_number": "EMEA/H/C/004883", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0023", "international_non_proprietary_name_common_name": "turoctocog alfa pegol", "active_substance": "turoctocog alfa pegol", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Esperoct can be used for all age groups.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "21/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "28/06/2019", "last_updated_date": "05/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/esperoct" }, { "category": "Human", "name_of_medicine": "Bevespi Aerosphere", "ema_product_number": "EMEA/H/C/004245", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0021", "international_non_proprietary_name_common_name": "glycopyrronium;formoterol fumarate dihydrate", "active_substance": "glycopyrronium;formoterol fumarate dihydrate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "formoterol and glycopyrronium bromide", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bevespi Aerosphere is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "02/12/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/12/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "05/02/2019", "last_updated_date": "03/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bevespi-aerosphere" }, { "category": "Human", "name_of_medicine": "Lumykras", "ema_product_number": "EMEA/H/C/005522", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0010/G", "international_non_proprietary_name_common_name": "sotorasib", "active_substance": "sotorasib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX73", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "21/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "11/11/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/01/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "10/11/2021", "last_updated_date": "03/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lumykras" }, { "category": "Human", "name_of_medicine": "Tavlesse", "ema_product_number": "EMEA/H/C/005012", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0018", "international_non_proprietary_name_common_name": "fostamatinib", "active_substance": "Fostamatinib disodium", "therapeutic_area_mesh": "Thrombocytopenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other systemic hemostatics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tavlesse is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Instituto Grifols S.A.", "european_commission_decision_date": "13/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "11/02/2020", "last_updated_date": "02/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tavlesse" }, { "category": "Veterinary", "name_of_medicine": "Prevexxion RN+HVT+IBD", "ema_product_number": "EMEA/V/C/005057", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "infectious bursal disease;Marek's disease vaccine (live recombinant)", "active_substance": "Live recombinant Marek’s disease virus, serotype 1, strain RN1250; Live recombinant turkey herpesvirus, expressing the VP2 protein of infectious bursal disease virus, strain vHVT013-69", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;avian herpes virus (marek's disease) + avian infectious bursal disease virus (gumboro disease) + newcastle disease virus/paramyxovirus", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/04/2021", "last_updated_date": "02/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/prevexxion-rnhvtibd" }, { "category": "Veterinary", "name_of_medicine": "Metacam", "ema_product_number": "EMEA/V/C/000033", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/03/2018", "last_updated_date": "02/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/metacam" }, { "category": "Human", "name_of_medicine": "Sancuso", "ema_product_number": "EMEA/H/C/002296", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0064", "international_non_proprietary_name_common_name": "granisetron", "active_substance": "granisetron", "therapeutic_area_mesh": "Vomiting;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A04AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiemetics and antinauseants;Serotonin (5HT3) antagonists", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days. Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Grünenthal GmbH", "european_commission_decision_date": "22/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/04/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "19/07/2018", "last_updated_date": "02/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sancuso" }, { "category": "Veterinary", "name_of_medicine": "Frontpro (previously Afoxolaner Merial)", "ema_product_number": "EMEA/V/C/005126", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "afoxolaner", "active_substance": "afoxolaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/05/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "07/06/2019", "last_updated_date": "02/12/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/frontpro" }, { "category": "Human", "name_of_medicine": "Lutetium (177Lu) chloride Billev (previously Illuzyce)", "ema_product_number": "EMEA/H/C/005859", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0005/G", "international_non_proprietary_name_common_name": "lutetium (177Lu) chloride", "active_substance": "lutetium (177Lu) chloride", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V10X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Therapeutic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lutetium (177Lu) chloride Billev is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Billev Pharma Aps", "european_commission_decision_date": "07/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "18/07/2022", "last_updated_date": "29/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lutetium-177lu-chloride-billev" }, { "category": "Human", "name_of_medicine": "Onivyde pegylated liposomal (previously Onivyde)", "ema_product_number": "EMEA/H/C/004125", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0038", "international_non_proprietary_name_common_name": "irinotecan hydrochloride trihydrate", "active_substance": "irinotecan anhydrous free-base", "therapeutic_area_mesh": "Pancreatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CE02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "ONIVYDE pegylated liposomal is indicated:- in combination with oxaliplatin, 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas,- in combination with 5-FU and LV for the treatment of metastatic adenocarcinoma of the pancreas, in adult patients who have progressed following gemcitabine based therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "28/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/10/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "22/05/2017", "last_updated_date": "29/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal" }, { "category": "Human", "name_of_medicine": "Akantior", "ema_product_number": "EMEA/H/C/005858", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "polihexanide", "active_substance": "Polihexanide", "therapeutic_area_mesh": "Acanthamoeba Keratitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01AX24", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Akantior is indicated for the treatment of Acanthamoeba keratitis in adults and children from 12 years of age.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SIFI SPA", "european_commission_decision_date": "22/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/05/2024", "last_updated_date": "29/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/akantior" }, { "category": "Human", "name_of_medicine": "Duloxetine Zentiva", "ema_product_number": "EMEA/H/C/003935", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000226488", "international_non_proprietary_name_common_name": "duloxetine", "active_substance": "duloxetine", "therapeutic_area_mesh": "Neuralgia;Depressive Disorder, Major;Anxiety Disorders;Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antidepressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment depressive disorder, diabetic neuropathic pain, anxiety disorder. Duloxetine Zentiva is indicated in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva, k.s.", "european_commission_decision_date": "19/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/08/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "17/05/2017", "last_updated_date": "29/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duloxetine-zentiva" }, { "category": "Human", "name_of_medicine": "Xultophy", "ema_product_number": "EMEA/H/C/002647", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG-1796", "international_non_proprietary_name_common_name": "insulin degludec;liraglutide", "active_substance": "insulin degludec;liraglutide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE56", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xultophy is indicated for the treatment of adults with type-2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "25/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "07/06/2018", "last_updated_date": "28/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xultophy" }, { "category": "Human", "name_of_medicine": "Fruzaqla", "ema_product_number": "EMEA/H/C/005979", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0004/G", "international_non_proprietary_name_common_name": "fruquintinib", "active_substance": "fruquintinib", "therapeutic_area_mesh": "Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EK", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fruzaqla as monotherapy is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF agents, and anti EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine tipiracil or regorafenib.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland", "european_commission_decision_date": "26/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "10/07/2024", "last_updated_date": "27/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla" }, { "category": "Human", "name_of_medicine": "Rixubis", "ema_product_number": "EMEA/H/C/003771", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0045", "international_non_proprietary_name_common_name": "nonacog gamma", "active_substance": "nonacog gamma", "therapeutic_area_mesh": "Hemophilia B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Baxalta Innovations GmbH", "european_commission_decision_date": "22/09/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/12/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "13/06/2017", "last_updated_date": "27/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rixubis" }, { "category": "Human", "name_of_medicine": "Vaniqa", "ema_product_number": "EMEA/H/C/000325", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0059", "international_non_proprietary_name_common_name": "eflornithine", "active_substance": "eflornithine", "therapeutic_area_mesh": "Hirsutism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D11AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other dermatological preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of facial hirsutism in women.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Almirall, S.A.", "european_commission_decision_date": "29/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/03/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "05/04/2017", "last_updated_date": "27/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vaniqa" }, { "category": "Human", "name_of_medicine": "Cervarix", "ema_product_number": "EMEA/H/C/000721", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2365", "international_non_proprietary_name_common_name": "human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)", "active_substance": "human papillomavirus1 type 16 L1 protein;human papillomavirus type 18 L1 protein", "therapeutic_area_mesh": "Papillomavirus Infections;Uterine Cervical Dysplasia;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BM02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Cervarix should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "26/04/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "42", "first_published_date": "17/05/2018", "last_updated_date": "26/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cervarix" }, { "category": "Human", "name_of_medicine": "Senshio", "ema_product_number": "EMEA/H/C/002780", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0048", "international_non_proprietary_name_common_name": "ospemifene", "active_substance": "ospemifene", "therapeutic_area_mesh": "Postmenopause", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03XC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Shionogi B.V.", "european_commission_decision_date": "01/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/01/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "13/09/2017", "last_updated_date": "25/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/senshio" }, { "category": "Human", "name_of_medicine": "Kauliv", "ema_product_number": "EMEA/H/C/004932", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0005/G", "international_non_proprietary_name_common_name": "teriparatide", "active_substance": "teriparatide", "therapeutic_area_mesh": "Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kauliv is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Strides Pharma (Cyprus) Limited", "european_commission_decision_date": "22/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/01/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "18/07/2022", "last_updated_date": "25/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kauliv" }, { "category": "Human", "name_of_medicine": "Pombiliti", "ema_product_number": "EMEA/H/C/005703", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0012", "international_non_proprietary_name_common_name": "cipaglucosidase alfa", "active_substance": "Cipaglucosidase alfa", "therapeutic_area_mesh": "Glycogen Storage Disease Type II", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset Pompe disease (acid ?-glucosidase [GAA] deficiency).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amicus Therapeutics Europe Limited", "european_commission_decision_date": "12/09/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/03/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "09/12/2022", "last_updated_date": "22/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pombiliti" }, { "category": "Human", "name_of_medicine": "Bydureon", "ema_product_number": "EMEA/H/C/002020", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0081", "international_non_proprietary_name_common_name": "exenatide", "active_substance": "exenatide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4.4, 4.5 and 5.1 for available data on different combinations). Bydureon is indicated for treatment of type 2 diabetes mellitus in combination with: Metformin Sulphonylurea Thiazolidinedione Metformin and sulphonylurea Metformin and thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "20/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/04/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/06/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "10/11/2017", "last_updated_date": "21/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bydureon" }, { "category": "Veterinary", "name_of_medicine": "Fevaxyn Pentofel", "ema_product_number": "EMEA/V/C/000030", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated feline panleukopenia virus, calicivirus, rhinotracheitis virus, leukaemia virus and Chlamydophila felis", "active_substance": "inactivated feline rhinotracheitis virus;inactivated feline calicivirus;inactivated feline Chlamydophila felis;inactivated feline leukaemia virus;inactivated feline panleukopenia virus", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "21/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/fevaxyn-pentofel" }, { "category": "Human", "name_of_medicine": "Tenkasi (previously Orbactiv)", "ema_product_number": "EMEA/H/C/003785", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0046", "international_non_proprietary_name_common_name": "oritavancin", "active_substance": "oritavancin (diphosphate)", "therapeutic_area_mesh": "Soft Tissue Infections;Skin Diseases, Bacterial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01XA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Menarini International Operations Luxembourg S.A.", "european_commission_decision_date": "19/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/03/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "25/06/2018", "last_updated_date": "20/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tenkasi" }, { "category": "Human", "name_of_medicine": "Nezglyal", "ema_product_number": "EMEA/H/C/005757", "medicine_status": "Refused", "opinion_status": "Negative", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "leriglitazone", "active_substance": "leriglitazone hydrochloride", "therapeutic_area_mesh": "Adrenoleukodystrophy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX23", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nezglyal is indicated for the treatment of male ALD patients aged 2 years and older with brain lesions to delay progression of cerebral adrenoleukodystrophy (cALD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Minoryx Therapeutics S.L.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "22/07/2024", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/01/2024", "last_updated_date": "20/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nezglyal" }, { "category": "Human", "name_of_medicine": "Ganfort", "ema_product_number": "EMEA/H/C/000668", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0042", "international_non_proprietary_name_common_name": "bimatoprost;timolol", "active_substance": "bimatoprost;timolol", "therapeutic_area_mesh": "Glaucoma, Open-Angle;Ocular Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01ED51", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "15/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/05/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "06/04/2017", "last_updated_date": "18/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ganfort" }, { "category": "Human", "name_of_medicine": "Lumigan", "ema_product_number": "EMEA/H/C/000391", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0067", "international_non_proprietary_name_common_name": "bimatoprost", "active_substance": "bimatoprost", "therapeutic_area_mesh": "Glaucoma, Open-Angle;Ocular Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01EE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Prostaglandin analogues;Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "15/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/03/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "38", "first_published_date": "18/05/2017", "last_updated_date": "18/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lumigan" }, { "category": "Human", "name_of_medicine": "Celsunax", "ema_product_number": "EMEA/H/C/005135", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0001", "international_non_proprietary_name_common_name": "ioflupane (123I)", "active_substance": "ioflupane (123i)", "therapeutic_area_mesh": "Radionuclide Imaging;Dementia;Movement Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09AB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Celsunax is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum: In adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy. Celsunax is unable to discriminate between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy. In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease. Celsunax is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pinax Pharma GmbH", "european_commission_decision_date": "14/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/06/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "01/07/2021", "last_updated_date": "15/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/celsunax" }, { "category": "Human", "name_of_medicine": "Buccolam", "ema_product_number": "EMEA/H/C/002267", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0061", "international_non_proprietary_name_common_name": "midazolam", "active_substance": "midazolam", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05CD08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults.BUCCOLAM must only be used by parents/carers where the patient has been diagnosed to have epilepsy.For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. See section 4.2.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Neuraxpharm Pharmaceuticals S.L.", "european_commission_decision_date": "21/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/09/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "25/07/2018", "last_updated_date": "13/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/buccolam" }, { "category": "Veterinary", "name_of_medicine": "Convenia", "ema_product_number": "EMEA/V/C/000098", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "cefovecin", "active_substance": "cefovecin (as sodium salt)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/04/2018", "last_updated_date": "11/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/convenia" }, { "category": "Veterinary", "name_of_medicine": "Cepedex", "ema_product_number": "EMEA/V/C/004376", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dexmedetomidine", "active_substance": "Dexmedetomidine hydrochloride", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Psycholeptics;Hypnotics and sedatives", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "04/05/2017", "last_updated_date": "11/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cepedex" }, { "category": "Veterinary", "name_of_medicine": "Cardalis", "ema_product_number": "EMEA/V/C/002524", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "benazepril hydrochloride;spironolactone", "active_substance": "benazepril hydrochloride;spironolactone", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "CARDIOVASCULAR SYSTEM", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/06/2017", "last_updated_date": "11/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cardalis" }, { "category": "Human", "name_of_medicine": "Omidria", "ema_product_number": "EMEA/H/C/003702", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0028/G", "international_non_proprietary_name_common_name": "phenylephrine;ketorolac", "active_substance": "ketorolac;phenylephrine", "therapeutic_area_mesh": "Lens Implantation, Intraocular;Pain, Postoperative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Omidria is indicated in adults for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Rayner Surgical (Ireland) Limited", "european_commission_decision_date": "29/05/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/07/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "31/01/2018", "last_updated_date": "08/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/omidria" }, { "category": "Veterinary", "name_of_medicine": "Canigen L4", "ema_product_number": "EMEA/V/C/004079", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "canine leptospirosis vaccine (inactivated)", "active_substance": "Inactivated Leptospira strains: L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000); L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001); L. interrogans serogroup Australis serovar Bratislava (strain As-05-073); L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/09/2017", "last_updated_date": "07/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/canigen-l4" }, { "category": "Veterinary", "name_of_medicine": "Broadline", "ema_product_number": "EMEA/V/C/002700", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "eprinomectin, fipronil, praziquantel, (S)-methoprene", "active_substance": "eprinomectin;fipronil;praziquantel;(S)-methoprene", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/06/2017", "last_updated_date": "07/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/broadline" }, { "category": "Veterinary", "name_of_medicine": "Bovela", "ema_product_number": "EMEA/V/C/003703", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bovine viral diarrhoea vaccine (modified live)", "active_substance": "modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9 and modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/12/2017", "last_updated_date": "07/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bovela" }, { "category": "Veterinary", "name_of_medicine": "Versican Plus Pi/L4", "ema_product_number": "EMEA/V/C/003683", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0012", "international_non_proprietary_name_common_name": "canine parainfluenza virus and Leptospira", "active_substance": "Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090 and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 (all inactivated)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "06/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/versican-plus-pi-l4" }, { "category": "Veterinary", "name_of_medicine": "Versican Plus Pi", "ema_product_number": "EMEA/V/C/003681", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0012", "international_non_proprietary_name_common_name": "canine parainfluenza virus", "active_substance": "canine parainfluenza type-2 virus, strain CPiV-2 Bio 15 (live attenuated)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "06/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/versican-plus-pi" }, { "category": "Veterinary", "name_of_medicine": "Versican Plus L4", "ema_product_number": "EMEA/V/C/003680", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0009", "international_non_proprietary_name_common_name": "canine leptospirosis vaccine (inactivated)", "active_substance": "Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 (all inactivated)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "06/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/versican-plus-l4" }, { "category": "Veterinary", "name_of_medicine": "Innovax-ND-IBD", "ema_product_number": "EMEA/V/C/004422", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2102/G", "international_non_proprietary_name_common_name": "Newcastle disease;infectious bursal disease;Marek's disease vaccine (live recombinant)", "active_substance": "cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of ND virus and the VP2 protein of IBD virus", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Live viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/08/2017", "last_updated_date": "06/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/innovax-nd-ibd" }, { "category": "Veterinary", "name_of_medicine": "Vaxxitek HVT+IBD", "ema_product_number": "EMEA/V/C/000065", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1450", "international_non_proprietary_name_common_name": "infectious bursal disease;Marek's disease vaccine (live recombinant)", "active_substance": "recombinant turkey herpesvirus, strain vhvt013-69, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Live viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/02/2018", "last_updated_date": "06/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vaxxitek-hvtibd" }, { "category": "Veterinary", "name_of_medicine": "Poulvac E. coli", "ema_product_number": "EMEA/V/C/002007", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0018", "international_non_proprietary_name_common_name": "Escherichia coli aroA gene deleted, type O78, strain EC34195 (live)", "active_substance": "Live aroA gene deleted Escherichia coli, type 078, strain EC34195", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "09/09/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/04/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/05/2017", "last_updated_date": "06/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/poulvac-e-coli" }, { "category": "Veterinary", "name_of_medicine": "Porcilis PCV M Hyo", "ema_product_number": "EMEA/V/C/003796", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0014", "international_non_proprietary_name_common_name": "porcine circovirus type 2 ORF2 subunit antigen;mycoplasma hyopneumoniae vaccine (inactivated)", "active_substance": "Porcine circovirus type 2 (PCV2) ORF2 subunit antigen, Mycoplasma hyopneumoniae J strain inactivated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "15/06/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/06/2018", "last_updated_date": "06/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/porcilis-pcv-m-hyo" }, { "category": "Human", "name_of_medicine": "Byetta", "ema_product_number": "EMEA/H/C/000698", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0082", "international_non_proprietary_name_common_name": "exenatide", "active_substance": "exenatide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Byetta is indicated for treatment of type-2 diabetes mellitus in combination with: metformin; sulphonylureas; thiazolidinediones; metformin and a sulphonylurea; metformin and a thiazolidinedione; in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and / or pioglitazone in adults who have not achieved adequate glycaemic control with these agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "05/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/11/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "26/06/2018", "last_updated_date": "06/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/byetta" }, { "category": "Human", "name_of_medicine": "Pemetrexed Sandoz", "ema_product_number": "EMEA/H/C/004011", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000224542", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed disodium hemipentahydrate", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Mesothelioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Malignant pleural mesothelioma Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Sandoz in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Sandoz is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "04/09/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/10/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "24/04/2018", "last_updated_date": "06/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-sandoz" }, { "category": "Veterinary", "name_of_medicine": "Porcilis ColiClos", "ema_product_number": "EMEA/V/C/002011", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "vaccine to provide passive immunity to the progeny against Escherichia coli and Clostridium perfringens in pigs", "active_substance": "Clostridium perfringens type C / Escherichia coli F4ab / E. coli F4ac / E. coli F5 / E. coli F6 / E. coli LT", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "05/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/porcilis-coliclos" }, { "category": "Veterinary", "name_of_medicine": "ArthriCox", "ema_product_number": "EMEA/V/C/005993", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "firocoxib", "active_substance": "firocoxib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products;Anti-inflammatory and anti-rheumatic products, non-steroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/09/2024", "last_updated_date": "05/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/arthricox" }, { "category": "Veterinary", "name_of_medicine": "Cirbloc M Hyo", "ema_product_number": "EMEA/V/C/006131", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "mycoplasma hyopneumoniae, strain 2940, inactivated;porcine circovirus 2, ORF2 capsid protein", "active_substance": "mycoplasma hyopneumoniae, strain 2940, inactivated;porcine circovirus 2, ORF2 capsid protein", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated viral and inactivated bacterial vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/09/2024", "last_updated_date": "05/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cirbloc-m-hyo" }, { "category": "Veterinary", "name_of_medicine": "Nobivac DP Plus", "ema_product_number": "EMEA/V/C/005251", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "canine distemper vaccine (live, attenuated) and canine parvovirus vaccine (live, recombinant)", "active_substance": "Live attenuated canine distemper virus strain Onderstepoort: 105.1 – 106.5 TCID50;Live recombinant canine parvovirus strain 630a: 105.1 – 106.7 TCID50", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/08/2021", "last_updated_date": "05/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobivac-dp-plus" }, { "category": "Veterinary", "name_of_medicine": "Hiprabovis IBR Marker Live", "ema_product_number": "EMEA/V/C/000158", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "live gene-deleted vaccine for intramuscular use for active immunisation of cattle against infectious bovine rhinotracheitis", "active_substance": "live gE- tk- double-gene-deleted bovine herpes virus type 1, strain CEDDEL: 106.3–107.3 CCID50", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/06/2017", "last_updated_date": "05/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/hiprabovis-ibr-marker-live" }, { "category": "Human", "name_of_medicine": "Vidaza", "ema_product_number": "EMEA/H/C/000978", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0062", "international_non_proprietary_name_common_name": "azacitidine", "active_substance": "azacitidine", "therapeutic_area_mesh": "Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:  intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification. Vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "01/11/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/10/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/12/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "18/05/2017", "last_updated_date": "05/11/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vidaza" }, { "category": "Human", "name_of_medicine": "Gliolan", "ema_product_number": "EMEA/H/C/000744", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0030", "international_non_proprietary_name_common_name": "5-aminolevulinic acid hydrochloride", "active_substance": "5-aminolevulinic acid hydrochloride", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (World Health Organization grade III and IV).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Photonamic GmbH & Co. KG", "european_commission_decision_date": "30/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/06/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/09/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "19/07/2018", "last_updated_date": "30/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gliolan" }, { "category": "Human", "name_of_medicine": "Translarna", "ema_product_number": "EMEA/H/C/002720", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0071", "international_non_proprietary_name_common_name": "ataluren", "active_substance": "ataluren", "therapeutic_area_mesh": "Muscular Dystrophy, Duchenne", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Translarna is indicated for the treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older. Efficacy has not been demonstrated in non-ambulatory patients. The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "PTC Therapeutics International Limited", "european_commission_decision_date": "28/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/01/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/07/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/03/2025", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "23/07/2018", "last_updated_date": "29/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/translarna" }, { "category": "Veterinary", "name_of_medicine": "Suvaxyn Aujeszky 783 + O/W", "ema_product_number": "EMEA/V/C/000038", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "live attenuated Aujeszky's disease virus", "active_substance": "live attenuated Aujeszky's disease virus", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "28/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/suvaxyn-aujeszky-783-o-w" }, { "category": "Human", "name_of_medicine": "Oxervate", "ema_product_number": "EMEA/H/C/004209", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0064", "international_non_proprietary_name_common_name": "cenegermin", "active_substance": "recombinant human nerve growth factor", "therapeutic_area_mesh": "Keratitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dompe' Farmaceutici S.p.A.", "european_commission_decision_date": "23/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/05/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "06/07/2017", "last_updated_date": "25/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/oxervate" }, { "category": "Human", "name_of_medicine": "Suliqua", "ema_product_number": "EMEA/H/C/004243", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0044", "international_non_proprietary_name_common_name": "insulin glargine;lixisenatide", "active_substance": "insulin glargine;lixisenatide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE54", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "22/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "14/09/2017", "last_updated_date": "25/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/suliqua" }, { "category": "Human", "name_of_medicine": "Tracleer", "ema_product_number": "EMEA/H/C/000401", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0107", "international_non_proprietary_name_common_name": "bosentan", "active_substance": "bosentan (as monohydrate)", "therapeutic_area_mesh": "Scleroderma, Systemic;Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.Efficacy has been shown in: Primary (idiopathic and familial) PAH; PAH secondary to scleroderma without significant interstitial pulmonary disease; PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology. Some improvements have also been shown in patients with PAH WHO functional class II. Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.  ", "european_commission_decision_date": "23/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/02/2002", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/05/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "45", "first_published_date": "20/11/2017", "last_updated_date": "25/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tracleer" }, { "category": "Veterinary", "name_of_medicine": "BTVPUR", "ema_product_number": "EMEA/V/C/002231", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated vaccine against bluetongue virus serotypes 1 and 8", "active_substance": "bluetongue-virus serotype-1 antigen;bluetongue virus serotype 8 antigen", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/04/2016", "last_updated_date": "24/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/btvpur" }, { "category": "Veterinary", "name_of_medicine": "Nobilis Influenza H5N2", "ema_product_number": "EMEA/V/C/000118", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1348", "international_non_proprietary_name_common_name": "adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5", "active_substance": "inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "18/03/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/06/2016", "last_updated_date": "24/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-influenza-h5n2" }, { "category": "Human", "name_of_medicine": "Onbevzi", "ema_product_number": "EMEA/H/C/005640", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0005", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Colorectal Neoplasms;Breast Neoplasms;Ovarian Neoplasms;Fallopian Tube Neoplasms;Peritoneal Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Uterine Cervical Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Onbevzi in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Onbevzi in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Onbevzi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Onbevzi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Onbevzi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Onbevzi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Onbevzi, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Onbevzi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Samsung Bioepis NL B.V.", "european_commission_decision_date": "11/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/11/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "05/03/2021", "last_updated_date": "24/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/onbevzi" }, { "category": "Human", "name_of_medicine": "Jylamvo", "ema_product_number": "EMEA/H/C/003756", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0023/G", "international_non_proprietary_name_common_name": "methotrexate", "active_substance": "methotrexate", "therapeutic_area_mesh": "Arthritis, Psoriatic;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Psoriasis;Arthritis, Rheumatoid;Arthritis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients. In oncology Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Oresund Pharma ApS", "european_commission_decision_date": "21/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/01/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/03/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "22/05/2018", "last_updated_date": "24/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jylamvo" }, { "category": "Veterinary", "name_of_medicine": "ProteqFlu", "ema_product_number": "EMEA/V/C/000073", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "equine influenza vaccine (live recombinant)", "active_substance": "Vcp 2242 virus / Vcp1529 virus / Vcp1533 virus / vCP3011 virus", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals;Live viral vaccines equine influenza virus", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "11/07/2014", "last_updated_date": "24/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/proteqflu" }, { "category": "Veterinary", "name_of_medicine": "Solensia", "ema_product_number": "EMEA/V/C/005179", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "frunevetmab", "active_substance": "frunevetmab", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Nervous system;Other analgesics and antipyretics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/06/2020", "last_updated_date": "24/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/solensia" }, { "category": "Human", "name_of_medicine": "Stayveer", "ema_product_number": "EMEA/H/C/002644", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0042", "international_non_proprietary_name_common_name": "bosentan monohydrate", "active_substance": "bosentan (as monohydrate)", "therapeutic_area_mesh": "Hypertension, Pulmonary;Scleroderma, Systemic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with World Health Organization (WHO) functional class III. Efficacy has been shown in: primary (idiopathic and familial) PAH; PAH secondary to scleroderma without significant interstitial pulmonary disease; PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger’s physiology. Some improvements have also been shown in patients with PAH WHO functional class II. Stayveer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital-ulcer disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "22/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/06/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "26/09/2017", "last_updated_date": "24/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/stayveer" }, { "category": "Veterinary", "name_of_medicine": "ProteqFlu-Te", "ema_product_number": "EMEA/V/C/000074", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "equine influenza (live recombinant) and tetanus vaccine", "active_substance": "Clostridium tetani toxoid / Vcp 2242 virus / Vcp1529 virus / Vcp1533 virus / vCP3011 virus", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for equidae;Live viral and inactivated bacterial vaccines;equine influenza virus + clostridium", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/07/2014", "last_updated_date": "24/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/proteqflu-te" }, { "category": "Veterinary", "name_of_medicine": "Innovax-ILT", "ema_product_number": "EMEA/V/C/003869", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian infectious laryngotracheitis and Marek’s disease vaccine (live)", "active_substance": "cell-associated live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "04/04/2018", "last_updated_date": "23/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/innovax-ilt" }, { "category": "Human", "name_of_medicine": "Memantine LEK", "ema_product_number": "EMEA/H/C/002630", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0010", "international_non_proprietary_name_common_name": "memantine", "active_substance": "memantine hydrochloride", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics;Other anti-dementia drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with moderate to severe Alzheimer’s disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharmathen S.A.", "european_commission_decision_date": "20/10/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/02/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/04/2013", "refusal_of_marketing_authorisation_date": "21/02/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "06/09/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "08/01/2018", "last_updated_date": "23/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/memantine-lek" }, { "category": "Human", "name_of_medicine": "Zydelig", "ema_product_number": "EMEA/H/C/003843", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0059", "international_non_proprietary_name_common_name": "idelalisib", "active_substance": "Idelalisib", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX47", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;Other antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zydelig is indicated in combination with an anti?CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies. Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "20/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "07/06/2018", "last_updated_date": "21/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zydelig" }, { "category": "Veterinary", "name_of_medicine": "Purevax RC", "ema_product_number": "EMEA/V/C/000091", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "vaccine against feline viral rhinotracheitis and feline calicivirosis", "active_substance": "attenuated feline rhinotracheitis herpesvirus (FHV F2 strain);inactivated feline calicivirosis antigens (FCV 431 and G1 strains)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/01/2015", "last_updated_date": "18/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/purevax-rc" }, { "category": "Human", "name_of_medicine": "Zytiga", "ema_product_number": "EMEA/H/C/002321", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0075", "international_non_proprietary_name_common_name": "abiraterone", "active_substance": "abiraterone acetate", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zytiga is indicated with prednisone or prednisolone for: the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.", "european_commission_decision_date": "16/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/09/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "12/06/2018", "last_updated_date": "18/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zytiga" }, { "category": "Human", "name_of_medicine": "Velcade", "ema_product_number": "EMEA/H/C/000539", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0103", "international_non_proprietary_name_common_name": "bortezomib", "active_substance": "bortezomib", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Velcade as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Velcade in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high dose chemotherapy with haematopoietic stem cell transplantation. Velcade in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation. Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "16/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/04/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "46", "first_published_date": "21/02/2017", "last_updated_date": "18/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/velcade" }, { "category": "Human", "name_of_medicine": "Ciambra", "ema_product_number": "EMEA/H/C/003788", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0008", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed disodium hemipentahydrate", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Mesothelioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Malignant pleural mesothelioma Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Ciambra is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Ciambra is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Menarini International Operations Luxembourg S.A.", "european_commission_decision_date": "17/08/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/12/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "12/10/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "03/08/2018", "last_updated_date": "17/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ciambra" }, { "category": "Human", "name_of_medicine": "Aldurazyme", "ema_product_number": "EMEA/H/C/000477", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0090", "international_non_proprietary_name_common_name": "laronidase", "active_substance": "laronidase", "therapeutic_area_mesh": "Mucopolysaccharidosis I", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi B.V.", "european_commission_decision_date": "09/09/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/02/2003", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/06/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "24/11/2021", "last_updated_date": "17/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aldurazyme" }, { "category": "Human", "name_of_medicine": "Gefitinib Mylan", "ema_product_number": "EMEA/H/C/004826", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0008", "international_non_proprietary_name_common_name": "gefitinib", "active_substance": "gefitinib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with activating mutations of EGFR TK.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Pharmaceuticals Limited", "european_commission_decision_date": "23/06/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/09/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "10/10/2018", "last_updated_date": "17/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gefitinib-mylan" }, { "category": "Veterinary", "name_of_medicine": "Purevax Rabies", "ema_product_number": "EMEA/V/C/002003", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rabies recombinant canarypox virus (vCP65)", "active_substance": "vCP65 virus", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "02/12/2015", "last_updated_date": "17/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/purevax-rabies" }, { "category": "Veterinary", "name_of_medicine": "Suvaxyn PRRS MLV", "ema_product_number": "EMEA/V/C/004276", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "porcine respiratory and reproductive syndrome virus, live", "active_substance": "modified live porcine respiratory and reproductive syndrome virus", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/08/2018", "last_updated_date": "17/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/suvaxyn-prrs-mlv" }, { "category": "Veterinary", "name_of_medicine": "Nobilis IB 4-91", "ema_product_number": "EMEA/V/C/000036", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "live attenuated vaccine against avian infectious bronchitis", "active_substance": "live attenuated avian infectious bronchitis virus variant strain 4-91", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/11/2017", "last_updated_date": "17/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-ib-4-91" }, { "category": "Human", "name_of_medicine": "Reyataz", "ema_product_number": "EMEA/H/C/000494", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0141/G", "international_non_proprietary_name_common_name": "atazanavir sulfate", "active_substance": "atazanavir (as sulfate)", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reyataz capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2). Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (? 4 PI mutations). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1). Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2). Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (? 4 PI mutations). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "05/09/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/03/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "57", "first_published_date": "22/02/2018", "last_updated_date": "16/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/reyataz" }, { "category": "Human", "name_of_medicine": "Mevlyq", "ema_product_number": "EMEA/H/C/006134", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0001", "international_non_proprietary_name_common_name": "eribulin", "active_substance": "Eribulin mesylate", "therapeutic_area_mesh": "Breast Neoplasms;Liposarcoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX41", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mevlyq is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. Mevlyq is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "YES Pharmaceutical Development Services GmbH", "european_commission_decision_date": "14/10/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/02/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "15/12/2023", "last_updated_date": "16/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mevlyq" }, { "category": "Veterinary", "name_of_medicine": "Versican Plus Pi/L4R", "ema_product_number": "EMEA/V/C/003682", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "canine parainfluenza virus, leptospira and rabies virus", "active_substance": "canine parainfluenza virus, leptospira and rabies virus.", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for canidae;Live and inactivated viral and bacterial vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "14/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/versican-plus-pi-l4r" }, { "category": "Veterinary", "name_of_medicine": "Equip WNV (previously Duvaxyn WNV)", "ema_product_number": "EMEA/V/C/000137", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "vaccine to aid in prevention of West Nile virus", "active_substance": "inactivated West Nile virus, strain VM-2", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for equidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "14/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/equip-wnv" }, { "category": "Veterinary", "name_of_medicine": "Versican Plus DHPPi/L4R", "ema_product_number": "EMEA/V/C/002759", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "live, attenuated Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus inactivated and Leptospira", "active_substance": "canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B, canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091...", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "live canine distemper virus + live canine adenovirus + live parainfl.virus + live canine parvovirus + inactivated rabies + inactivated leptospira;Immunologicals for canidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "14/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/versican-plus-dhppi-l4r" }, { "category": "Veterinary", "name_of_medicine": "Aivlosin", "ema_product_number": "EMEA/V/C/000083", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tylvalosin", "active_substance": "tylvalosin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiinfectives for systemic use;Antibacterials for systemic use;Macrolides", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/12/2017", "last_updated_date": "14/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/aivlosin" }, { "category": "Veterinary", "name_of_medicine": "Porcilis PCV ID", "ema_product_number": "EMEA/V/C/003942", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "porcine circovirus vaccine (inactivated)", "active_substance": "porcine circovirus type 2 ORF2 subunit antigen", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/03/2018", "last_updated_date": "14/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/porcilis-pcv-id" }, { "category": "Veterinary", "name_of_medicine": "Arti-Cell Forte", "ema_product_number": "EMEA/V/C/004727", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells", "active_substance": "chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Other drugs for disorders of the musculo-skeletal system", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/06/2018", "last_updated_date": "14/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/arti-cell-forte" }, { "category": "Human", "name_of_medicine": "Halaven", "ema_product_number": "EMEA/H/C/002084", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0070", "international_non_proprietary_name_common_name": "eribulin", "active_substance": "Eribulin", "therapeutic_area_mesh": "Breast Neoplasms;Liposarcoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX41", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease (see section 5.1). Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments. Halaven is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eisai GmbH", "european_commission_decision_date": "26/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/03/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "16/11/2017", "last_updated_date": "11/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/halaven" }, { "category": "Veterinary", "name_of_medicine": "Purevax RCPCh FeLV", "ema_product_number": "EMEA/V/C/000085", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia, feline leukeamia and feline Chlamydophila infections", "active_substance": "attenuated feline rhinotracheitis herpesvirus (FHV F2 strain);inactivated feline calicivirosis antigens (FCV 431 and G1 strains);attenuated feline panleucopenia virus (PLI IV);FeLV recombinant canarypox virus (vCP97);attenuated Chlamydophila felis (905 strain)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for felidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "05/05/2015", "last_updated_date": "11/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/purevax-rcpch-felv" }, { "category": "Veterinary", "name_of_medicine": "Purevax RCPCh", "ema_product_number": "EMEA/V/C/000088", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline Chlamydophila infections", "active_substance": "attenuated feline rhinotracheitis herpesvirus (FHV F2 strain);inactivated feline calicivirosis antigens (FCV 431 and G1 strains);attenuated Chlamydophila felis (905 strain);attenuated feline panleucopenia virus (PLI IV)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for felidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "05/05/2015", "last_updated_date": "11/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/purevax-rcpch" }, { "category": "Veterinary", "name_of_medicine": "Innovax-ND-ILT", "ema_product_number": "EMEA/V/C/005190", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Marek's disease vaccine, Newcastle disease vaccine & infectious laryngotracheitis vaccine (live recombinant)", "active_substance": "cell-associated live recombinant turkey herpesvirus (strain HVT/NDV/ILT) expressing the fusion protein of newcastle disease virus and the glycoproteins gD and gI of infectious laryngotracheitis virus", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "03/02/2021", "last_updated_date": "11/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/innovax-nd-ilt" }, { "category": "Veterinary", "name_of_medicine": "Divence IBR Marker Live", "ema_product_number": "EMEA/V/C/006260", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bovine herpesvirus type 1 (live) vaccine", "active_substance": "infectious bovine rhinotracheitis virus, strain CEDDEL, gE- tk- double-gene deleted, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae;Live viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/06/2024", "last_updated_date": "10/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/divence-ibr-marker-live" }, { "category": "Human", "name_of_medicine": "Oxbryta", "ema_product_number": "EMEA/H/C/004869", "medicine_status": "Suspended", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010983/202308", "international_non_proprietary_name_common_name": "voxelotor", "active_substance": "voxelotor", "therapeutic_area_mesh": "Anemia;Anemia, Hemolytic;Anemia, Sickle Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "17/05/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "14/12/2021", "last_updated_date": "08/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/oxbryta" }, { "category": "Veterinary", "name_of_medicine": "Zeleris", "ema_product_number": "EMEA/V/C/004099", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "florfenicol;meloxicam", "active_substance": "florfenicol;meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use;Amphenicols;combinations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/05/2017", "last_updated_date": "03/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zeleris" }, { "category": "Human", "name_of_medicine": "Viekirax", "ema_product_number": "EMEA/H/C/003839", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "EMEA/H/C/WS/2430", "international_non_proprietary_name_common_name": "ombitasvir;paritaprevir;ritonavir", "active_substance": "ombitasvir;paritaprevir;ritonavir", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AP53", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. For hepatitis C virus (HCV) genotype specific activity.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Deutschland GmbH & Co. KG", "european_commission_decision_date": "12/08/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/01/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "25/09/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "31/08/2018", "last_updated_date": "02/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/viekirax" }, { "category": "Human", "name_of_medicine": "Exviera", "ema_product_number": "EMEA/H/C/003837", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2430", "international_non_proprietary_name_common_name": "dasabuvir", "active_substance": "dasabuvir sodium", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AP09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. For hepatitis C virus (HCV) genotype specific activity.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Ltd", "european_commission_decision_date": "12/08/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2004", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/01/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "25/09/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "10/04/2018", "last_updated_date": "01/10/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exviera" }, { "category": "Human", "name_of_medicine": "Dificlir", "ema_product_number": "EMEA/H/C/002087", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0052/G", "international_non_proprietary_name_common_name": "fidaxomicin", "active_substance": "fidaxomicin", "therapeutic_area_mesh": "Clostridium Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A07AA12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antidiarrheals, intestinal antiinflammatory / antiinfective agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg. Consideration should be given to official guidelines on the appropriate use of antibacterial agents. Dificlir granules for oral suspension is indicated for the treatment of Clostridioides  difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age. Consideration should be given to official guidelines on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Tillotts Pharma GmbH", "european_commission_decision_date": "01/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/09/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/12/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "17/05/2018", "last_updated_date": "30/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dificlir" }, { "category": "Human", "name_of_medicine": "Kinharto", "ema_product_number": "EMEA/H/C/006112", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "omecamtiv mecarbil", "active_substance": "omecamtiv mecarbil dihydrochloride hydrate", "therapeutic_area_mesh": "Heart Failure, Systolic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01CX10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction less than 30%", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cytokinetics (Ireland) Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "07/05/2024", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "07/05/2024", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/05/2024", "last_updated_date": "30/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kinharto" }, { "category": "Human", "name_of_medicine": "Giapreza", "ema_product_number": "EMEA/H/C/004930", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0031", "international_non_proprietary_name_common_name": "angiotensin II", "active_substance": "angiotensin II acetate", "therapeutic_area_mesh": "Hypotension;Shock", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Giapreza is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Paion Pharma GmbH", "european_commission_decision_date": "19/09/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "10/10/2019", "last_updated_date": "25/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/giapreza" }, { "category": "Human", "name_of_medicine": "Entacapone Orion", "ema_product_number": "EMEA/H/C/002440", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0023", "international_non_proprietary_name_common_name": "entacapone", "active_substance": "entacapone", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Orion Corporation", "european_commission_decision_date": "20/09/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "15/12/2016", "last_updated_date": "24/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/entacapone-orion" }, { "category": "Human", "name_of_medicine": "Repaglinide Accord", "ema_product_number": "EMEA/H/C/002318", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR-0000228115", "international_non_proprietary_name_common_name": "repaglinide", "active_substance": "repaglinide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "23/09/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/10/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/12/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "19/09/2016", "last_updated_date": "23/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/repaglinide-accord" }, { "category": "Veterinary", "name_of_medicine": "Porcilis PCV M Hyo ID", "ema_product_number": "EMEA/V/C/006289", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)", "active_substance": "porcine circovirus type 2, ORF2 capsid protein;Mycoplasma hyopneumoniae, strain J, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated viral and inactivated bacterial vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/07/2024", "last_updated_date": "19/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/porcilis-pcv-m-hyo-id" }, { "category": "Veterinary", "name_of_medicine": "Cevac Salmune ETI K", "ema_product_number": "EMEA/V/C/006118", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Salmonella enteritidis, Salmonella typhimurium and Salmonella infantis vaccine (inactivated) for chickens", "active_substance": "Salmonella enterica, subsp. enterica, serovar Enteritidis, strain 038-90, inactivated; Salmonella enterica, subsp. enterica, serovar Typhimurium, strain 076-94, inactivated; and Salmonella enterica, subsp. enterica, serovar Infantis, strain SM-595, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/07/2024", "last_updated_date": "19/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cevac-salmune-eti-k" }, { "category": "Veterinary", "name_of_medicine": "Cepeloron", "ema_product_number": "EMEA/V/C/006254", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "spironolactone", "active_substance": "spironolactone", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Aldosterone antagonists", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/07/2024", "last_updated_date": "19/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cepeloron" }, { "category": "Human", "name_of_medicine": "Comtess", "ema_product_number": "EMEA/H/C/000170", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0064", "international_non_proprietary_name_common_name": "entacapone", "active_substance": "entacapone", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Orion Corporation", "european_commission_decision_date": "05/09/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/05/1998", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/09/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "15/12/2016", "last_updated_date": "18/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/comtess" }, { "category": "Human", "name_of_medicine": "Peyona (previously Nymusa)", "ema_product_number": "EMEA/H/C/001014", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0032", "international_non_proprietary_name_common_name": "caffeine", "active_substance": "Caffeine citrate", "therapeutic_area_mesh": "Apnea", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06BC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of primary apnoea of premature newborns.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiesi Farmaceutici SpA", "european_commission_decision_date": "27/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "21/09/2017", "last_updated_date": "18/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/peyona" }, { "category": "Human", "name_of_medicine": "Pomalidomide Accord", "ema_product_number": "EMEA/H/C/006273", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pomalidomide", "active_substance": "Pomalidomide", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pomalidomide Accord in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Accord in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "26/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/05/2024", "last_updated_date": "17/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-accord" }, { "category": "Human", "name_of_medicine": "Vemlidy", "ema_product_number": "EMEA/H/C/004169", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0040", "international_non_proprietary_name_common_name": "tenofovir alafenamide", "active_substance": "tenofovir alafenamide fumarate", "therapeutic_area_mesh": "Hepatitis B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vemlidy is indicated for the treatment of chronic hepatitis B (CHB) in adults and paediatric patients 6 years of age and older weighing at least 25 kg (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "26/05/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "28/05/2018", "last_updated_date": "17/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vemlidy" }, { "category": "Veterinary", "name_of_medicine": "Dexdomitor", "ema_product_number": "EMEA/V/C/000070", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dexmedetomidine", "active_substance": "Dexmedetomidine hydrochloride", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Psycholeptics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "03/05/2018", "last_updated_date": "17/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/dexdomitor" }, { "category": "Human", "name_of_medicine": "Bonviva", "ema_product_number": "EMEA/H/C/000501", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2451", "international_non_proprietary_name_common_name": "ibandronic acid", "active_substance": "ibandronic acid", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Atnahs Pharma Netherlands B.V.", "european_commission_decision_date": "25/01/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/10/2003", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/02/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "10/07/2018", "last_updated_date": "16/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bonviva" }, { "category": "Human", "name_of_medicine": "Bondronat", "ema_product_number": "EMEA/H/C/000101", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "H/C/WS2451", "international_non_proprietary_name_common_name": "ibandronic acid", "active_substance": "ibandronic acid", "therapeutic_area_mesh": "Hypercalcemia;Breast Neoplasms;Neoplasm Metastasis;Fractures, Bone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bondronat is indicated for: prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases; treatment of tumour-induced hypercalcaemia with or without metastases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Atnahs Pharma Netherlands B.V.", "european_commission_decision_date": "25/01/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/02/1996", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/06/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "10/07/2018", "last_updated_date": "16/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bondronat" }, { "category": "Human", "name_of_medicine": "Dzuveo", "ema_product_number": "EMEA/H/C/004335", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0012", "international_non_proprietary_name_common_name": "sufentanil", "active_substance": "sufentanil citrate", "therapeutic_area_mesh": "Pain", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N01AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anesthetics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dzuveo is indicated for the management of acute moderate to severe pain in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoire Aguettant", "european_commission_decision_date": "02/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/06/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "25/09/2018", "last_updated_date": "12/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dzuveo" }, { "category": "Human", "name_of_medicine": "Resolor", "ema_product_number": "EMEA/H/C/001012", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0057", "international_non_proprietary_name_common_name": "prucalopride", "active_substance": "prucalopride succinate", "therapeutic_area_mesh": "Constipation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A06AX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for constipation", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland", "european_commission_decision_date": "14/12/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "05/02/2018", "last_updated_date": "12/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/resolor" }, { "category": "Human", "name_of_medicine": "Xarelto", "ema_product_number": "EMEA/H/C/000944", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0111", "international_non_proprietary_name_common_name": "rivaroxaban", "active_substance": "rivaroxaban", "therapeutic_area_mesh": "Arthroplasty, Replacement;Venous Thromboembolism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AF01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "09/09/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/09/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "42", "first_published_date": "02/07/2018", "last_updated_date": "12/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xarelto" }, { "category": "Veterinary", "name_of_medicine": "Nobilis Multriva RT+IBm+ND+EDS", "ema_product_number": "EMEA/V/C/006043", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian metapneumovirus;avian infectious bronchitis virus;Newcastle disease virus vaccine (inactivated);egg drop syndrome virus vaccine (inactivated)", "active_substance": "avian infectious bronchitis;Newcastle disease;egg drop syndrome virus vaccine (inactivated);sorbitan oleate;turkey rhinotracheitis virus (inactivated)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/05/2024", "last_updated_date": "10/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-multriva-rtibmndeds" }, { "category": "Veterinary", "name_of_medicine": "Nobilis Multriva RT+IBm+ND+Gm+REOm", "ema_product_number": "EMEA/V/C/005989", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian infectious bronchitis;avian reovirus;avian infectious bursal disease;Newcastle disease;turkey rhinotracheitis virus", "active_substance": "avian infectious bronchitis;avian reovirus;avian infectious bursal disease;Newcastle disease;turkey rhinotracheitis virus (inactivated)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/05/2024", "last_updated_date": "10/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-multriva-rtibmndgmreom" }, { "category": "Human", "name_of_medicine": "Nyxthracis (previously Obiltoxaximab SFL)", "ema_product_number": "EMEA/H/C/005169", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0009", "international_non_proprietary_name_common_name": "obiltoxaximab", "active_substance": "nyxthracis", "therapeutic_area_mesh": "Anthrax", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BB22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Obiltoxaximab SFL is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to Bacillus anthracis (see section 5.1). Obiltoxaximab SFL is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SFL Pharmaceuticals Deutschland GmbH", "european_commission_decision_date": "14/12/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/09/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/11/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "27/11/2020", "last_updated_date": "09/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nyxthracis" }, { "category": "Human", "name_of_medicine": "Savene", "ema_product_number": "EMEA/H/C/000682", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0052", "international_non_proprietary_name_common_name": "dexrazoxane", "active_substance": "dexrazoxane hydrochloride", "therapeutic_area_mesh": "Extravasation of Diagnostic and Therapeutic Materials", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AF02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Savene is indicated for the treatment of anthracycline extravasation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CNX Therapeutics Ireland Limited", "european_commission_decision_date": "22/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/07/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "08/02/2018", "last_updated_date": "06/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/savene" }, { "category": "Human", "name_of_medicine": "Ivabradine Accord", "ema_product_number": "EMEA/H/C/004241", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0016/G", "international_non_proprietary_name_common_name": "ivabradine", "active_substance": "ivabradine hydrochloride", "therapeutic_area_mesh": "Angina Pectoris;Heart Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01EB17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated : - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. (see section 5.1)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "31/08/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/03/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/05/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "23/03/2018", "last_updated_date": "06/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ivabradine-accord" }, { "category": "Human", "name_of_medicine": "Fabrazyme", "ema_product_number": "EMEA/H/C/000370", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0130", "international_non_proprietary_name_common_name": "agalsidase beta", "active_substance": "agalsidase beta", "therapeutic_area_mesh": "Fabry Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi B.V.", "european_commission_decision_date": "30/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/03/2001", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/08/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "01/02/2018", "last_updated_date": "04/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fabrazyme" }, { "category": "Human", "name_of_medicine": "Carmustine medac (previously Carmustine Obvius)", "ema_product_number": "EMEA/H/C/004326", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000182021", "international_non_proprietary_name_common_name": "carmustine", "active_substance": "carmustine", "therapeutic_area_mesh": "Hodgkin Disease;Lymphoma, Non-Hodgkin", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): Brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases (Hodgkin’s disease / Non-hodgkin’s lymphoma).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "european_commission_decision_date": "29/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/07/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "19/07/2018", "last_updated_date": "03/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/carmustine-medac" }, { "category": "Human", "name_of_medicine": "Pramipexole Teva", "ema_product_number": "EMEA/H/C/000940", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0057", "international_non_proprietary_name_common_name": "pramipexole", "active_substance": "pramipexole dihydrochloride monohydrate", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pramipexole Teva is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). Pramipexole Teva is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "29/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/10/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/12/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "14/12/2017", "last_updated_date": "02/09/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pramipexole-teva" }, { "category": "Human", "name_of_medicine": "Tevagrastim", "ema_product_number": "EMEA/H/C/000827", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0099/G", "international_non_proprietary_name_common_name": "filgrastim", "active_substance": "filgrastim", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Tevagrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva GmbH", "european_commission_decision_date": "21/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "31/05/2018", "last_updated_date": "30/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tevagrastim" }, { "category": "Human", "name_of_medicine": "Ratiograstim", "ema_product_number": "EMEA/H/C/000825", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0091/G", "international_non_proprietary_name_common_name": "filgrastim", "active_substance": "filgrastim", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ratiograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Ratiograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ? 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Ratiograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Ratiograstim is indicated for the treatment of persistent neutropenia (ANC ? 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ratiopharm GmbH", "european_commission_decision_date": "21/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "31/05/2018", "last_updated_date": "30/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ratiograstim" }, { "category": "Human", "name_of_medicine": "Iasibon", "ema_product_number": "EMEA/H/C/002025", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000222634", "international_non_proprietary_name_common_name": "ibandronic acid", "active_substance": "ibandronic acid", "therapeutic_area_mesh": "Hypercalcemia;Fractures, Bone;Neoplasm Metastasis;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Concentrate for solution for infusion Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour-induced hypercalcaemia with or without metastases. Film-coated Tablets Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharmathen S.A.", "european_commission_decision_date": "28/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/10/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/01/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "18/10/2016", "last_updated_date": "30/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/iasibon" }, { "category": "Human", "name_of_medicine": "Zaltrap", "ema_product_number": "EMEA/H/C/002532", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0072", "international_non_proprietary_name_common_name": "aflibercept", "active_substance": "aflibercept", "therapeutic_area_mesh": "Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX44", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of metastatic colorectal cancer (MCRC).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "27/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/11/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/02/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "21/09/2017", "last_updated_date": "29/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zaltrap" }, { "category": "Human", "name_of_medicine": "Ibandronic Acid Teva", "ema_product_number": "EMEA/H/C/001195", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0022", "international_non_proprietary_name_common_name": "ibandronic acid", "active_substance": "ibandronic acid", "therapeutic_area_mesh": "Breast Neoplasms;Neoplasm Metastasis;Fractures, Bone;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ibandronic acid 50mg Ibandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Ibandronic acid 150mg Treatment of osteoporosis in postmenopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "16/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/06/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/09/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "10/11/2016", "last_updated_date": "28/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ibandronic-acid-teva" }, { "category": "Human", "name_of_medicine": "Pioglitazone Accord", "ema_product_number": "EMEA/H/C/002277", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/VR/0000225173", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: as monotherapy in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "19/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/01/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "28/06/2016", "last_updated_date": "27/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pioglitazone-accord" }, { "category": "Human", "name_of_medicine": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "ema_product_number": "EMEA/H/C/005675", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0096", "international_non_proprietary_name_common_name": "COVID-19 Vaccine (ChAdOx1-S [recombinant])", "active_substance": "ChAdOx1-SARS-COV-2", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BN02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vaxzevria is indicated for active immunisation to prevent COVID 19 caused by SARS CoV 2, in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "07/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/01/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/01/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/03/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "18/02/2021", "last_updated_date": "22/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria" }, { "category": "Human", "name_of_medicine": "Tremelimumab AstraZeneca", "ema_product_number": "EMEA/H/C/004650", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG1659", "international_non_proprietary_name_common_name": "tremelimumab", "active_substance": "tremelimumab", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX20", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "04/09/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/02/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "09/12/2022", "last_updated_date": "22/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tremelimumab-astrazeneca" }, { "category": "Human", "name_of_medicine": "Rilutek", "ema_product_number": "EMEA/H/C/000109", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0075", "international_non_proprietary_name_common_name": "riluzole", "active_substance": "riluzole", "therapeutic_area_mesh": "Amyotrophic Lateral Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Rilutek extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that Rilutek exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Rilutek has not been shown to be effective in the late stages of ALS. Safety and efficacy of Rilutek has only been studied in ALS. Therefore, Rilutek should not be used in patients with any other form of motor-neurone disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "24/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/02/1996", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/06/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "13/11/2017", "last_updated_date": "21/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rilutek" }, { "category": "Human", "name_of_medicine": "Oprymea", "ema_product_number": "EMEA/H/C/000941", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0043", "international_non_proprietary_name_common_name": "pramipexole", "active_substance": "pramipexole dihydrochloride monohydrate", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Oprymea is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or \"on off\" fluctuations). Oprymea is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "20/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/09/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "12/03/2018", "last_updated_date": "20/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/oprymea" }, { "category": "Human", "name_of_medicine": "Myozyme", "ema_product_number": "EMEA/H/C/000636", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0099", "international_non_proprietary_name_common_name": "alglucosidase alfa", "active_substance": "alglucosidase alfa", "therapeutic_area_mesh": "Glycogen Storage Disease Type II", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Myozyme is indicated for long-term enzyme-replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid-?-glucosidase deficiency). In patients with late-onset Pompe disease the evidence of efficacy is limited.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi B.V.", "european_commission_decision_date": "14/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/03/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "08/09/2017", "last_updated_date": "16/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/myozyme" }, { "category": "Human", "name_of_medicine": "Lymphoseek", "ema_product_number": "EMEA/H/C/002085", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0023/G", "international_non_proprietary_name_common_name": "tilmanocept", "active_substance": "tilmanocept", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09IA09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Tumour detection;Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Radiolabelled Lymphoseek is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity. External imaging and intraoperative evaluation may be performed using a gamma detection device.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Navidea Biopharmaceuticals Europe Ltd.", "european_commission_decision_date": "10/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/09/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "16/11/2017", "last_updated_date": "14/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lymphoseek" }, { "category": "Human", "name_of_medicine": "Intelence", "ema_product_number": "EMEA/H/C/000900", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0070", "international_non_proprietary_name_common_name": "etravirine", "active_substance": "Etravirine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AG04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Non-nucleoside reverse transcriptase inhibitors;Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age. This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "08/08/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/08/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "13/07/2017", "last_updated_date": "13/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/intelence" }, { "category": "Human", "name_of_medicine": "Fasturtec", "ema_product_number": "EMEA/H/C/000331", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0070", "international_non_proprietary_name_common_name": "rasburicase", "active_substance": "rasburicase", "therapeutic_area_mesh": "Hyperuricemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AF07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "13/05/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/02/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "23/11/2017", "last_updated_date": "12/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fasturtec" }, { "category": "Human", "name_of_medicine": "Tizveni", "ema_product_number": "EMEA/H/C/005542", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tislelizumab", "active_substance": "tislelizumab", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FF09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Non-small cell lung cancer (NSCLC)Tizveni in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous non-small cell lung cancer whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have:• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or• metastatic NSCLC.Tizveni in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have:• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or• metastatic NSCLC.Tizveni as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BeiGene Ireland Ltd", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/02/2024", "last_updated_date": "02/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tizveni" }, { "category": "Human", "name_of_medicine": "Evicel", "ema_product_number": "EMEA/H/C/000898", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0099", "international_non_proprietary_name_common_name": "human fibrinogen;human thrombin", "active_substance": "human fibrinogen;human thrombin", "therapeutic_area_mesh": "Hemostasis, Surgical", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. Evicel is also indicated as suture support for haemostasis in vascular surgery.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Omrix Biopharmaceuticals N. V.", "european_commission_decision_date": "16/03/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/07/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/10/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "11/09/2017", "last_updated_date": "02/08/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evicel" }, { "category": "Human", "name_of_medicine": "Mozobil", "ema_product_number": "EMEA/H/C/001030", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/N/0000184403", "international_non_proprietary_name_common_name": "plerixafor", "active_substance": "Plerixafor", "therapeutic_area_mesh": "Multiple Myeloma;Hematopoietic Stem Cell Transplantation;Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AX16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi B.V.", "european_commission_decision_date": "16/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/05/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "19/10/2017", "last_updated_date": "31/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mozobil" }, { "category": "Human", "name_of_medicine": "Taxotere", "ema_product_number": "EMEA/H/C/000073", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "EMA/N/0000220958", "international_non_proprietary_name_common_name": "docetaxel", "active_substance": "docetaxel", "therapeutic_area_mesh": "Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Stomach Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "30/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/07/1995", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/11/1995", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "52", "first_published_date": "01/02/2018", "last_updated_date": "31/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/taxotere" }, { "category": "Human", "name_of_medicine": "VidPrevtyn Beta", "ema_product_number": "EMEA/H/C/005754", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0007/G", "international_non_proprietary_name_common_name": "COVID-19 Vaccine (recombinant, adjuvanted)", "active_substance": "SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain)", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BN04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "VidPrevtyn Beta is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received an mRNA or adenoviral vector COVID-19 vaccine (see sections 4.2 and 5.1 in product information document). The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Pasteur", "european_commission_decision_date": "11/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/11/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/03/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "11/11/2022", "last_updated_date": "30/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vidprevtyn-beta" }, { "category": "Human", "name_of_medicine": "Upstelda", "ema_product_number": "EMEA/H/C/006415", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ustekinumab", "active_substance": "ustekinumab", "therapeutic_area_mesh": "Psoriasis;Arthritis, Psoriatic;Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of moderate to severe plaque psoriasis in adults, children and adolescents, active psoriatic arthritis in adults and Crohn’s Disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Technology (Ireland) UC", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "22/03/2024", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/07/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/upstelda" }, { "category": "Human", "name_of_medicine": "Pemetrexed Krka", "ema_product_number": "EMEA/H/C/003958", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0009", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed disodium", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Mesothelioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Malignant pleural mesothelioma Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "KRKA d.d.", "european_commission_decision_date": "15/02/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/03/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/05/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "22/05/2018", "last_updated_date": "30/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-krka" }, { "category": "Human", "name_of_medicine": "Fareston", "ema_product_number": "EMEA/H/C/000091", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00002999/202309", "international_non_proprietary_name_common_name": "toremifene", "active_substance": "toremifene", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.Fareston is not recommended for patients with estrogen receptor negative tumours.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Orion Corporation", "european_commission_decision_date": "26/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/1995", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "26/07/2018", "last_updated_date": "30/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fareston" }, { "category": "Human", "name_of_medicine": "Suboxone", "ema_product_number": "EMEA/H/C/000697", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00002113/202309", "international_non_proprietary_name_common_name": "buprenorphine;naloxone", "active_substance": "buprenorphine;naloxone", "therapeutic_area_mesh": "Opioid-Related Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07BC51", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Substitution treatment for opioid-drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Indivior Europe Limited", "european_commission_decision_date": "24/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/07/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/09/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "31/05/2018", "last_updated_date": "29/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/suboxone" }, { "category": "Human", "name_of_medicine": "Prezista", "ema_product_number": "EMEA/H/C/000707", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0123", "international_non_proprietary_name_common_name": "darunavir", "active_substance": "darunavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). In deciding to initiate treatment with PREZISTA co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA. PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection. PREZISTA 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens: For the treatment of HIV 1 infection in antiretroviral treatment (ART) experienced adult patients, including those that have been highly pre treated. For the treatment of HIV 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. In deciding to initiate treatment with PREZISTA co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA. PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection. PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). PREZISTA 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART) naïve. ART experienced with no darunavir resistance associated mutations (DRV RAMs) and who have plasma HIV 1 RNA < 100,000 copies/ml and CD4+ cell count ? 100 cells x 106/L. In deciding to initiate treatment with PREZISTA in such ART experienced patients, genotypic testing should guide the use of PREZISTA.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "24/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/12/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/02/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "55", "first_published_date": "06/07/2018", "last_updated_date": "26/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prezista" }, { "category": "Human", "name_of_medicine": "Symtuza", "ema_product_number": "EMEA/H/C/004391", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0052", "international_non_proprietary_name_common_name": "darunavir;cobicistat;emtricitabine;tenofovir alafenamide", "active_substance": "darunavir;cobicistat;emtricitabine;tenofovir alafenamide", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use;Antivirals for treatment of HIV infections, combinations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symtuza is indicated for the treatment of human immunodeficiency virus type 1 (HIV?1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). Genotypic testing should guide the use of Symtuza.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "24/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/07/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "06/07/2017", "last_updated_date": "25/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/symtuza" }, { "category": "Human", "name_of_medicine": "Nulibry", "ema_product_number": "EMEA/H/C/005378", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0008/G", "international_non_proprietary_name_common_name": "fosdenopterin", "active_substance": "fosdenopterin hydrobromide dihydrate", "therapeutic_area_mesh": "Metal Metabolism, Inborn Errors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX19", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "NULIBRY is indicated for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "TMC Pharma (EU) Limited", "european_commission_decision_date": "24/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "18/07/2022", "last_updated_date": "25/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nulibry" }, { "category": "Human", "name_of_medicine": "Entecavir Accord", "ema_product_number": "EMEA/H/C/004458", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0011", "international_non_proprietary_name_common_name": "entecavir", "active_substance": "Entecavir", "therapeutic_area_mesh": "Hepatitis B, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. decompensated liver disease. For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B. Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "01/07/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/07/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/09/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "26/09/2017", "last_updated_date": "24/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/entecavir-accord" }, { "category": "Human", "name_of_medicine": "DuoResp Spiromax", "ema_product_number": "EMEA/H/C/002348", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG1765", "international_non_proprietary_name_common_name": "budesonide;formoterol", "active_substance": "Budesonide;formoterol fumarate dihydrate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive;Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Asthma DuoResp Spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?? adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?? adrenoceptor agonists. or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?? adrenoceptor agonists. COPDDuoResp Spiromax is indicated in adults, aged 18 years and older for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV?) <70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "08/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/04/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "10/07/2018", "last_updated_date": "24/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duoresp-spiromax" }, { "category": "Human", "name_of_medicine": "BiResp Spiromax", "ema_product_number": "EMEA/H/C/003890", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG1765", "international_non_proprietary_name_common_name": "budesonide;formoterol", "active_substance": "Budesonide;formoterol fumarate dihydrate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive;Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Asthma  BiResp Spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?? adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?? adrenoceptor agonists. or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?? adrenoceptor agonists. COPDBiResp Spiromax is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV?) <70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "18/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/04/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "25/06/2018", "last_updated_date": "24/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/biresp-spiromax" }, { "category": "Human", "name_of_medicine": "Evoltra", "ema_product_number": "EMEA/H/C/000613", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0083", "international_non_proprietary_name_common_name": "clofarabine", "active_substance": "clofarabine", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi B.V.", "european_commission_decision_date": "17/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/05/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "14/11/2017", "last_updated_date": "22/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evoltra" }, { "category": "Human", "name_of_medicine": "Byannli (previously Paliperidone Janssen-Cilag International)", "ema_product_number": "EMEA/H/C/005486", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0006", "international_non_proprietary_name_common_name": "paliperidone", "active_substance": "paliperidone palmitate", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Byannli (previously Paliperidone Janssen-Cilag International) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.  ", "european_commission_decision_date": "19/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/04/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/06/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "07/07/2020", "last_updated_date": "22/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/byannl" }, { "category": "Human", "name_of_medicine": "Trevicta (previously Paliperidone Janssen)", "ema_product_number": "EMEA/H/C/004066", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0032", "international_non_proprietary_name_common_name": "paliperidone", "active_substance": "paliperidone palmitate", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trevicta, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitate injectable product.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "19/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/12/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "31/05/2018", "last_updated_date": "22/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trevicta" }, { "category": "Human", "name_of_medicine": "Xeplion", "ema_product_number": "EMEA/H/C/002105", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0057", "international_non_proprietary_name_common_name": "paliperidone", "active_substance": "paliperidone palmitate", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.", "european_commission_decision_date": "19/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/03/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "31/05/2018", "last_updated_date": "22/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xeplion" }, { "category": "Human", "name_of_medicine": "Luveris", "ema_product_number": "EMEA/H/C/000292", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0100", "international_non_proprietary_name_common_name": "lutropin alfa", "active_substance": "lutropin alfa", "therapeutic_area_mesh": "Ovulation Induction;Infertility, Female", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03GA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Luveris in association with a follicle-stimulating-hormone (FSH) preparation is recommended for the stimulation of follicular development in women with severe luteinising-hormone (LH) and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level <1.2 IU/l.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Europe B.V. ", "european_commission_decision_date": "19/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/11/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "20/08/2018", "last_updated_date": "22/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/luveris" }, { "category": "Human", "name_of_medicine": "DuoPlavin", "ema_product_number": "EMEA/H/C/001143", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0073", "international_non_proprietary_name_common_name": "clopidogrel;acetylsalicylic acid", "active_substance": "clopidogrel;acetylsalicylic acid", "therapeutic_area_mesh": "Acute Coronary Syndrome;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC30", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "DuoPlavin is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed-dose combination medicinal product for continuation of therapy in: Non ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention (PCI); ST segment elevation acute myocardial infarction (STEMI) in patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Winthrop Industrie", "european_commission_decision_date": "17/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/12/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/03/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "18/01/2018", "last_updated_date": "19/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duoplavin" }, { "category": "Human", "name_of_medicine": "Agilus", "ema_product_number": "EMEA/H/C/006009", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dantrolene sodium, hemiheptahydrate", "active_substance": "dantrolene sodium, hemiheptahydrate", "therapeutic_area_mesh": "Malignant Hyperthermia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M03CA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "MUSCLE RELAXANTS", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "In combination with adequate support measures, Agilus is indicated for the treatment of malignant hyperthermia in adults and children of all ages.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Norgine B.V.", "european_commission_decision_date": "29/05/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/05/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/03/2024", "last_updated_date": "18/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/agilus" }, { "category": "Human", "name_of_medicine": "Palynziq", "ema_product_number": "EMEA/H/C/004744", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0038", "international_non_proprietary_name_common_name": "pegvaliase", "active_substance": "pegvaliase", "therapeutic_area_mesh": "Phenylketonurias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB19", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioMarin International Limited", "european_commission_decision_date": "19/04/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/02/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/05/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "29/05/2019", "last_updated_date": "12/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/palynziq" }, { "category": "Human", "name_of_medicine": "Invega", "ema_product_number": "EMEA/H/C/000746", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0073", "international_non_proprietary_name_common_name": "paliperidone", "active_substance": "paliperidone", "therapeutic_area_mesh": "Schizophrenia;Psychotic Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Invega is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older. Invega is indicated for the treatment of schizoaffective disorder in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "09/07/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/06/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "31/05/2018", "last_updated_date": "12/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/invega" }, { "category": "Human", "name_of_medicine": "Pixuvri", "ema_product_number": "EMEA/H/C/002055", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0050", "international_non_proprietary_name_common_name": "pixantrone dimaleate", "active_substance": "pixantrone dimaleate", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01DB11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth-line or greater chemotherapy in patients who are refractory to last therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "09/11/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/02/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/05/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "12/06/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "23/08/2018", "last_updated_date": "10/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pixuvri" }, { "category": "Human", "name_of_medicine": "Zevalin", "ema_product_number": "EMEA/H/C/000547", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0053", "international_non_proprietary_name_common_name": "ibritumomab tiuxetan", "active_substance": "ibritumomab tiuxetan", "therapeutic_area_mesh": "Lymphoma, Follicular", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V10XX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Therapeutic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zevalin is indicated in adults. [90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsedorrefractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ceft Biopharma s.r.o.", "european_commission_decision_date": "10/06/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/09/2003", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "04/01/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "08/12/2017", "last_updated_date": "10/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zevalin" }, { "category": "Human", "name_of_medicine": "Duloxetine Lilly", "ema_product_number": "EMEA/H/C/004000", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "H/C/PSUSA/00001187/202308", "international_non_proprietary_name_common_name": "duloxetine", "active_substance": "duloxetine", "therapeutic_area_mesh": "Neuralgia;Diabetic Neuropathies;Depressive Disorder, Major", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Duloxetine Lilly is indicated in adults for: Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder Duloxetine Lilly is indicated in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "20/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/10/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/12/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "26/01/2017", "last_updated_date": "09/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duloxetine-lilly" }, { "category": "Human", "name_of_medicine": "Cymbalta", "ema_product_number": "EMEA/H/C/000572", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00001187/202308", "international_non_proprietary_name_common_name": "duloxetine", "active_substance": "duloxetine", "therapeutic_area_mesh": "Anxiety Disorders;Diabetic Neuropathies;Depressive Disorder, Major", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Cymbalta is indicated in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "20/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/2004", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/12/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "26/01/2017", "last_updated_date": "09/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cymbalta" }, { "category": "Human", "name_of_medicine": "Yentreve", "ema_product_number": "EMEA/H/C/000545", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00001187/202308", "international_non_proprietary_name_common_name": "duloxetine", "active_substance": "duloxetine hydrochloride", "therapeutic_area_mesh": "Urinary Incontinence, Stress", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "17/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/08/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "19/12/2016", "last_updated_date": "09/07/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yentreve" }, { "category": "Veterinary", "name_of_medicine": "Palladia", "ema_product_number": "EMEA/V/C/000150", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "toceranib", "active_substance": "toceranib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antineoplastic agents", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "28/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/palladia" }, { "category": "Veterinary", "name_of_medicine": "Zuprevo", "ema_product_number": "EMEA/V/C/002009", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tildipirosin", "active_substance": "tildipirosin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiinfectives for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/03/2016", "last_updated_date": "28/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zuprevo" }, { "category": "Veterinary", "name_of_medicine": "Ypozane", "ema_product_number": "EMEA/V/C/000112", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "osaterone acetate", "active_substance": "osaterone acetate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Urologicals", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/12/2016", "last_updated_date": "28/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/ypozane" }, { "category": "Veterinary", "name_of_medicine": "Zactran", "ema_product_number": "EMEA/V/C/000129", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "gamithromycin", "active_substance": "gamithromycin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/01/2018", "last_updated_date": "28/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zactran" }, { "category": "Veterinary", "name_of_medicine": "SevoFlo", "ema_product_number": "EMEA/V/C/000072", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "sevoflurane", "active_substance": "sevoflurane", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anesthetics, general", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/11/2017", "last_updated_date": "28/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/sevoflo" }, { "category": "Veterinary", "name_of_medicine": "Bravecto Plus", "ema_product_number": "EMEA/V/C/004440", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fluralaner;moxidectin", "active_substance": "fluralaner;moxidectin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents;Endectocides;Milbemycins", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/05/2018", "last_updated_date": "28/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bravecto-plus" }, { "category": "Veterinary", "name_of_medicine": "Naxcel", "ema_product_number": "EMEA/V/C/000079", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ceftiofur", "active_substance": "ceftiofur", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "28/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/naxcel" }, { "category": "Veterinary", "name_of_medicine": "Onsior", "ema_product_number": "EMEA/V/C/000127", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "robenacoxib", "active_substance": "robenacoxib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products, non-steroids;Coxibs", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "03/08/2018", "last_updated_date": "28/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/onsior" }, { "category": "Veterinary", "name_of_medicine": "Aservo EquiHaler", "ema_product_number": "EMEA/V/C/004991", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ciclesonide", "active_substance": "ciclesonide", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Respiratory system;Other drugs for obstructive airway diseases, inhalants", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/02/2020", "last_updated_date": "28/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/aservo-equihaler" }, { "category": "Veterinary", "name_of_medicine": "Stronghold", "ema_product_number": "EMEA/V/C/000050", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "selamectin", "active_substance": "selamectin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents;Endectocides;Macrocyclic lactones", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2017", "last_updated_date": "28/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/stronghold" }, { "category": "Veterinary", "name_of_medicine": "Cerenia", "ema_product_number": "EMEA/V/C/000106", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "maropitant", "active_substance": "maropitant citrate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Alimentary tract and metabolism", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/08/2017", "last_updated_date": "28/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cerenia" }, { "category": "Human", "name_of_medicine": "Mepsevii", "ema_product_number": "EMEA/H/C/004438", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0040/G", "international_non_proprietary_name_common_name": "vestronidase alfa", "active_substance": "vestronidase alfa", "therapeutic_area_mesh": "Mucopolysaccharidosis VII", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Enzymes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mepsevii is indicated for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ultragenyx Germany GmbH", "european_commission_decision_date": "26/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "23/08/2018", "last_updated_date": "28/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mepsevii" }, { "category": "Human", "name_of_medicine": "Dabigatran etexilate Teva", "ema_product_number": "EMEA/H/C/006023", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dabigatran etexilate", "active_substance": "dabigatran etexilate mesilate", "therapeutic_area_mesh": "Venous Thromboembolism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AE07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of venous thromboembolic events", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/06/2024", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/06/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dabigatran-etexilate-teva-0" }, { "category": "Veterinary", "name_of_medicine": "Exzolt", "ema_product_number": "EMEA/V/C/004344", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fluralaner", "active_substance": "fluralaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparaciticides, insecticides and repellents", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/08/2017", "last_updated_date": "25/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/exzolt" }, { "category": "Veterinary", "name_of_medicine": "Zolvix", "ema_product_number": "EMEA/V/C/000154", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "monepantel", "active_substance": "monepantel", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anthelmintics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/03/2018", "last_updated_date": "25/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zolvix" }, { "category": "Veterinary", "name_of_medicine": "Trocoxil", "ema_product_number": "EMEA/V/C/000132", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "mavacoxib", "active_substance": "mavacoxib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/12/2017", "last_updated_date": "25/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/trocoxil" }, { "category": "Veterinary", "name_of_medicine": "Evicto", "ema_product_number": "EMEA/V/C/004973", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "selamectin", "active_substance": "selamectin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Endectocides", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/08/2019", "last_updated_date": "25/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/evicto" }, { "category": "Veterinary", "name_of_medicine": "Semintra", "ema_product_number": "EMEA/V/C/002436", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "telmisartan", "active_substance": "telmisartan", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Agents acting on the renin-angiotensin system;Angiotensin II antagonists, plain", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/05/2018", "last_updated_date": "25/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/semintra" }, { "category": "Veterinary", "name_of_medicine": "Apoquel", "ema_product_number": "EMEA/V/C/002688", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "oclacitinib maleate", "active_substance": "oclacitinib maleate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Agents for dermatitis, excluding corticosteroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/07/2018", "last_updated_date": "25/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/apoquel" }, { "category": "Veterinary", "name_of_medicine": "Sileo", "ema_product_number": "EMEA/V/C/003764", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dexmedetomidine", "active_substance": "Dexmedetomidine hydrochloride", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Nervous system;Other hypnotics and sedatives", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/08/2018", "last_updated_date": "21/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/sileo" }, { "category": "Human", "name_of_medicine": "Atosiban SUN", "ema_product_number": "EMEA/H/C/002329", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0000170579", "international_non_proprietary_name_common_name": "atosiban", "active_substance": "atosiban (as acetate)", "therapeutic_area_mesh": "Obstetric Labor, Premature", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G02CX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other gynecologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Atosiban is indicated to delay imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 seconds’ duration at a rate of ? 4 per 30 minutes; a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ? 50%; a gestational age from 24 until 33 completed weeks; a normal foetal heart rate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "21/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/07/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "16/08/2018", "last_updated_date": "20/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/atosiban-sun" }, { "category": "Veterinary", "name_of_medicine": "Lotimax", "ema_product_number": "EMEA/V/C/006441", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "lotilaner", "active_substance": "lotilaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/03/2024", "last_updated_date": "17/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/lotimax" }, { "category": "Veterinary", "name_of_medicine": "Lexylan", "ema_product_number": "EMEA/V/C/006103", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "cefalexin", "active_substance": "cefalexin sodium;cefalexin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/02/2024", "last_updated_date": "17/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/lexylan" }, { "category": "Veterinary", "name_of_medicine": "Trilorale", "ema_product_number": "EMEA/V/C/006124", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "trilostane", "active_substance": "trilostane", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiadrenal preparations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/03/2024", "last_updated_date": "17/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/trilorale" }, { "category": "Veterinary", "name_of_medicine": "Alcort", "ema_product_number": "EMEA/V/C/006143", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "hydrocortisone aceponate", "active_substance": "hydrocortisone aceponate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Corticosteroids, dermatological preparations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/02/2024", "last_updated_date": "17/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/alcort" }, { "category": "Veterinary", "name_of_medicine": "Trilocur", "ema_product_number": "EMEA/V/C/006128", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "trilostane", "active_substance": "trilostane", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiadrenal preparations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/03/2024", "last_updated_date": "17/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/trilocur" }, { "category": "Veterinary", "name_of_medicine": "Bonqat", "ema_product_number": "EMEA/V/C/005489", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pregabalin", "active_substance": "pregabalin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiepileptics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/05/2021", "last_updated_date": "17/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bonqat" }, { "category": "Veterinary", "name_of_medicine": "Recocam", "ema_product_number": "EMEA/V/C/002247", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Oxicams", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/08/2016", "last_updated_date": "17/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/recocam" }, { "category": "Veterinary", "name_of_medicine": "Forceris", "ema_product_number": "EMEA/V/C/004329", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "toltrazuril;iron (III) ion", "active_substance": "toltrazuril;iron (III) ion", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "toltrazuril, combinations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/02/2019", "last_updated_date": "17/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/forceris" }, { "category": "Veterinary", "name_of_medicine": "Activyl", "ema_product_number": "EMEA/V/C/000163", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "indoxacarb", "active_substance": "indoxacarb", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for topical use, incl. insecticides;indoxacarb", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/05/2017", "last_updated_date": "17/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/activyl" }, { "category": "Veterinary", "name_of_medicine": "Bovilis Blue-8", "ema_product_number": "EMEA/V/C/004776", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bluetongue virus vaccine (inactivated) serotype 8", "active_substance": "bluetongue virus vaccine, serotype 8 (inactivated)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Ovidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/07/2018", "last_updated_date": "17/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bovilis-blue-8" }, { "category": "Veterinary", "name_of_medicine": "Advocate", "ema_product_number": "EMEA/V/C/000076", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "imidacloprid;moxidectin", "active_substance": "imidacloprid;moxidectin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/02/2018", "last_updated_date": "13/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/advocate" }, { "category": "Veterinary", "name_of_medicine": "Suprelorin", "ema_product_number": "EMEA/V/C/000109", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "deslorelin acetate", "active_substance": "deslorelin acetate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Pituitary and hypothalamic hormones and analogues", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/06/2018", "last_updated_date": "13/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/suprelorin" }, { "category": "Veterinary", "name_of_medicine": "Gumbohatch", "ema_product_number": "EMEA/V/C/004967", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian infectious bursal disease vaccine (live)", "active_substance": "live attenuated infectious bursal disease virus (IBDV), strain 1052", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Live viral vaccines;avian infectious bursal disease virus (gumboro disease)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/12/2019", "last_updated_date": "13/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/gumbohatch" }, { "category": "Veterinary", "name_of_medicine": "Melovem", "ema_product_number": "EMEA/V/C/000152", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Oxicams", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/06/2014", "last_updated_date": "13/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/melovem" }, { "category": "Veterinary", "name_of_medicine": "Vectra 3D", "ema_product_number": "EMEA/V/C/002555", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dinotefuran, permethrin, and pyriproxyfen", "active_substance": "dinotefuran;pyriproxyfen;permethrin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "permethrin, combinations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/08/2018", "last_updated_date": "13/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vectra-3d" }, { "category": "Veterinary", "name_of_medicine": "Simparica Trio", "ema_product_number": "EMEA/V/C/004846", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "sarolaner;moxidectin;pyrantel embonate", "active_substance": "moxidectin;sarolaner;pyrantel embonate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitics", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/10/2019", "last_updated_date": "13/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/simparica-trio" }, { "category": "Veterinary", "name_of_medicine": "Coxevac", "ema_product_number": "EMEA/V/C/000155", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated Coxiella burnetii vaccine", "active_substance": "inactivated Coxiella burnetii vaccine, strain Nine Mile", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae;Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/12/2017", "last_updated_date": "13/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/coxevac" }, { "category": "Veterinary", "name_of_medicine": "Credelio Plus", "ema_product_number": "EMEA/V/C/005325", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "lotilaner / milbemycin oxime", "active_substance": "lotilaner;milbemycin oxime", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Endectocides", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/02/2021", "last_updated_date": "11/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelio-plus" }, { "category": "Veterinary", "name_of_medicine": "Simparica", "ema_product_number": "EMEA/V/C/003991", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "sarolaner", "active_substance": "sarolaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/10/2017", "last_updated_date": "11/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/simparica" }, { "category": "Human", "name_of_medicine": "Veltassa", "ema_product_number": "EMEA/H/C/004180", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0034/G", "international_non_proprietary_name_common_name": "patiromer", "active_substance": "patiromer sorbitex calcium", "therapeutic_area_mesh": "Hyperkalemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AE09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of hyperkalemia and hyperphosphatemia", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Veltassa is indicated for the treatment of hyperkalaemia in adults and adolescents aged 12 to 17 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vifor Fresenius Medical Care Renal Pharma France", "european_commission_decision_date": "06/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/05/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "19/07/2017", "last_updated_date": "11/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/veltassa" }, { "category": "Veterinary", "name_of_medicine": "Improvac", "ema_product_number": "EMEA/V/C/000136", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "gonadotropin releasing factor (GnRF) analogue-protein conjugate", "active_substance": "synthetic peptide analogue of GnRF conjugated to diptheria toxoid", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/03/2018", "last_updated_date": "11/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/improvac" }, { "category": "Veterinary", "name_of_medicine": "Respivac aMPV (previously Respivac TRT)", "ema_product_number": "EMEA/V/C/006160", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "turkey rhinotracheitis virus, strain 1062, live", "active_substance": "turkey rhinotracheitis virus, strain 1062, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live viral vaccines;Domestic fowl", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/04/2024", "last_updated_date": "11/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/respivac-ampv" }, { "category": "Human", "name_of_medicine": "Lamivudine Teva", "ema_product_number": "EMEA/H/C/001113", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0026", "international_non_proprietary_name_common_name": "lamivudine", "active_substance": "lamivudine", "therapeutic_area_mesh": "Hepatitis B, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "06/06/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "18/05/2018", "last_updated_date": "07/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lamivudine-teva" }, { "category": "Human", "name_of_medicine": "Parsabiv", "ema_product_number": "EMEA/H/C/003995", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0017", "international_non_proprietary_name_common_name": "etelcalcetide", "active_substance": "etelcalcetide hydrochloride", "therapeutic_area_mesh": "Hyperparathyroidism, Secondary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05BX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis;Anti-parathyroid agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "16/09/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/11/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "23/08/2018", "last_updated_date": "07/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/parsabiv" }, { "category": "Human", "name_of_medicine": "Myocet liposomal (previously Myocet)", "ema_product_number": "EMEA/H/C/000297", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0073", "international_non_proprietary_name_common_name": "doxorubicin", "active_substance": "doxorubicin hydrochloride", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01DB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Myocet liposomal, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CHEPLAPHARM Arzneimittel GmbH", "european_commission_decision_date": "29/05/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/04/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/07/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "20/07/2018", "last_updated_date": "06/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/myocet-liposomal" }, { "category": "Human", "name_of_medicine": "PecFent", "ema_product_number": "EMEA/H/C/001164", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0061", "international_non_proprietary_name_common_name": "fentanyl", "active_substance": "fentanyl", "therapeutic_area_mesh": "Pain;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02AB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gruenenthal GmbH", "european_commission_decision_date": "16/05/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/08/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "19/07/2018", "last_updated_date": "05/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pecfent" }, { "category": "Veterinary", "name_of_medicine": "Credelio", "ema_product_number": "EMEA/V/C/004247", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "lotilaner", "active_substance": "lotilaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for systemic use;Isoxazolines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/07/2018", "last_updated_date": "03/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelio" }, { "category": "Veterinary", "name_of_medicine": "Circovac", "ema_product_number": "EMEA/V/C/000114", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "adjuvanted inactivated vaccine against porcine circovirus type 2", "active_substance": "inactivated porcine circovirus type 2 (PCV2)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CEVA-Phylaxia Zrt.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/06/2017", "last_updated_date": "03/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/circovac" }, { "category": "Veterinary", "name_of_medicine": "Bravecto", "ema_product_number": "EMEA/V/C/002526", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fluralaner", "active_substance": "fluralaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for systemic use;Isoxazolines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/05/2018", "last_updated_date": "03/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bravecto" }, { "category": "Veterinary", "name_of_medicine": "Innovax-ND-H5", "ema_product_number": "EMEA/V/C/006362", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "turkey herpesvirus, strain HVT-ND-H5 (cell-associated), expressing fusion protein gene of Newcastle disease virus and haemagglutinin gene of Avian influenza virus subtype H5", "active_substance": "turkey herpesvirus, strain HVT-ND-H5 (cell-associated), expressing fusion protein gene of Newcastle disease virus and haemagglutinin gene of Avian influenza virus subtype H5", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Live viral vaccines;Domestic fowl", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/04/2024", "last_updated_date": "03/06/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/innovax-nd-h5" }, { "category": "Veterinary", "name_of_medicine": "Nobilis Multriva RT+IBm+ND+Gm+REOm+EDS", "ema_product_number": "EMEA/V/C/005887", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "avian metapneumovirus;avian infectious bronchitis;Newcastle disease;avian infectious bursal disease;egg drop syndrome virus vaccine (inactivated)", "active_substance": "avian metapneumovirus;avian infectious bronchitis;Newcastle disease;avian infectious bursal disease;avian reovirus and egg drop syndrome virus vaccine (inactivated)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Domestic fowl;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/03/2024", "last_updated_date": "31/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-multriva-rtibmndgmreomeds" }, { "category": "Veterinary", "name_of_medicine": "Divence Tetra", "ema_product_number": "EMEA/V/C/006222", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bovine viral diarrhoea virus type 1 and type 2 (subunit recombinant);bovine parainfluenza 3 virus (inactivated) and bovine respiratory syncytial virus vaccine", "active_substance": "bovine viral diarrhoea virus type 1 and type 2 (subunit recombinant);bovine parainfluenza 3 virus (inactivated) and bovine respiratory syncytial virus vaccine", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae;Live and inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/03/2024", "last_updated_date": "31/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/divence-tetra" }, { "category": "Veterinary", "name_of_medicine": "Divence Penta", "ema_product_number": "EMEA/V/C/006175", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bovine parainfluenza virus 3, strain SF-4 Reisinger, inactivated;bovine respiratory syncytial virus, strain LYM-56, live;bovine viral diarrhoea virus 1, E2 recombinant protein;bovine viral diarrhoea virus 2, E2 recombinant protein;infectious bovine rhinotracheitis virus, strain CEDDEL, gE- tk- double-gene deleted, live", "active_substance": "bovine parainfluenza virus 3, strain SF-4 Reisinger, inactivated;live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56;bovine viral diarrhoea virus 1, E2 recombinant protein;bovine viral diarrhoea virus 2, E2 recombinant protein;infectious bovine rhinotracheitis virus, strain CEDDEL, gE- tk- double-gene deleted, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae;Live and inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/02/2024", "last_updated_date": "31/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/divence-penta" }, { "category": "Veterinary", "name_of_medicine": "Enteroporc Coli", "ema_product_number": "EMEA/V/C/005148", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "neonatal piglet colibacillosis vaccine (recombinant, inactivated)", "active_substance": "Inactivated fimbrial adhesins of Escherichia coli F4ab;Inactivated fimbrial adhesins of Escherichia coli F4ac;Inactivated fimbrial adhesins of Escherichia coli F5;Inactivated fimbrial adhesins of Escherichia coli F6", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/04/2021", "last_updated_date": "31/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/enteroporc-coli" }, { "category": "Veterinary", "name_of_medicine": "Meloxoral", "ema_product_number": "EMEA/V/C/000151", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Musculo-skeletal system;Anti-inflammatory and anti-rheumatic products, non-steroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/01/2017", "last_updated_date": "31/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/meloxoral" }, { "category": "Human", "name_of_medicine": "Nuceiva", "ema_product_number": "EMEA/H/C/004587", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0037", "international_non_proprietary_name_common_name": "botulinum toxin type a", "active_substance": "Botulinum toxin type A", "therapeutic_area_mesh": "Skin Aging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M03AX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other muscle relaxants, peripherally acting agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Evolus Pharma B.V.", "european_commission_decision_date": "17/05/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/09/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "14/10/2019", "last_updated_date": "28/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nuceiva" }, { "category": "Veterinary", "name_of_medicine": "Vectormune FP ILT", "ema_product_number": "EMEA/V/C/005482", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fowlpox and avian infectious laryngotracheitis vaccine (live, recombinant)", "active_substance": "recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live viral vaccines;Domestic fowl", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/10/2020", "last_updated_date": "27/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vectormune-fp-ilt" }, { "category": "Human", "name_of_medicine": "Vyxeos liposomal (previously Vyxeos)", "ema_product_number": "EMEA/H/C/004282", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0043", "international_non_proprietary_name_common_name": "daunorubicin;cytarabine", "active_substance": "daunorubicin hydrochloride;cytarabine", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XY01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Jazz Pharmaceuticals Ireland Limited", "european_commission_decision_date": "23/04/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "29/06/2018", "last_updated_date": "24/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vyxeos-liposomal" }, { "category": "Veterinary", "name_of_medicine": "Strangvac", "ema_product_number": "EMEA/V/C/005309", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Streptococcus equi vaccine (recombinant proteins)", "active_substance": "recombinant Streptococcus equi protein CCE;recombinant Streptococcus equi protein Eq85;recombinant Streptococcus equi protein IdeE", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for equidae;Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia);streptococcus", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/06/2021", "last_updated_date": "23/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/strangvac" }, { "category": "Veterinary", "name_of_medicine": "Senvelgo", "ema_product_number": "EMEA/V/C/005972", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "velagliflozin", "active_substance": "velagliflozin L-proline monohydrate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Sodium-glucose co-transporter 2 (SGLT2) inhibitors", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/10/2023", "last_updated_date": "23/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/senvelgo" }, { "category": "Veterinary", "name_of_medicine": "Loxitab", "ema_product_number": "EMEA/V/C/006099", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products;Oxicams", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/09/2023", "last_updated_date": "23/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/loxitab" }, { "category": "Veterinary", "name_of_medicine": "Eluracat", "ema_product_number": "EMEA/V/C/005948", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "capromorelin tartrate", "active_substance": "capromorelin tartrate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anterior pituitary lobe hormones and analogues", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2023", "last_updated_date": "23/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/eluracat" }, { "category": "Veterinary", "name_of_medicine": "Oxmax", "ema_product_number": "EMEA/V/C/005132", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Hemoglobin betafumaril (bovine)", "active_substance": "Hemoglobin betafumaril (bovine)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Blood substitutes and plasma protein fractions", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/09/2023", "last_updated_date": "23/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/oxmax" }, { "category": "Human", "name_of_medicine": "Temozolomide Teva", "ema_product_number": "EMEA/H/C/001126", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "VR/0000170853", "international_non_proprietary_name_common_name": "temozolomide", "active_substance": "temozolomide", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V. ", "european_commission_decision_date": "07/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/01/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "23/05/2018", "last_updated_date": "16/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/temozolomide-teva" }, { "category": "Human", "name_of_medicine": "Ghryvelin (previously Macimorelin Aeterna Zentaris)", "ema_product_number": "EMEA/H/C/004660", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0020", "international_non_proprietary_name_common_name": "macimorelin", "active_substance": "macimorelin acetate", "therapeutic_area_mesh": "Diagnostic Techniques, Endocrine", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V04CD06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "macimorelin", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. GHRYVELIN is indicated for the diagnosis of growth hormone deficiency (GHD) in adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Atnahs Pharma Netherlands B.V.", "european_commission_decision_date": "12/01/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/11/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "26/02/2019", "last_updated_date": "13/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ghryvelin" }, { "category": "Human", "name_of_medicine": "Onglyza", "ema_product_number": "EMEA/H/C/001039", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0057", "international_non_proprietary_name_common_name": "saxagliptin", "active_substance": "saxagliptin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Add-on combination therapy Onglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy: in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate; as triple oral therapy: in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control; as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "19/04/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "17/08/2017", "last_updated_date": "13/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/onglyza" }, { "category": "Human", "name_of_medicine": "Plerixafor Accord", "ema_product_number": "EMEA/H/C/005943", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0003", "international_non_proprietary_name_common_name": "plerixafor", "active_substance": "Plerixafor", "therapeutic_area_mesh": "Multiple Myeloma;Hematopoietic Stem Cell Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AX16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adult patients Plerixafor Accord is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4.2). Paediatric patients (1 to less than 18 years) Plerixafor Accord is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.2).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "07/05/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/12/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "06/02/2023", "last_updated_date": "13/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/plerixafor-accord" }, { "category": "Human", "name_of_medicine": "Mirapexin", "ema_product_number": "EMEA/H/C/000134", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "H/C/WS2626", "international_non_proprietary_name_common_name": "pramipexole", "active_substance": "pramipexole dihydrochloride monohydrate", "therapeutic_area_mesh": "Restless Legs Syndrome;Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mirapexin is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). Mirapexin is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "14/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/02/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "42", "first_published_date": "20/06/2018", "last_updated_date": "02/05/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mirapexin" }, { "category": "Human", "name_of_medicine": "Pirfenidone axunio (previously Pirfenidone AET)", "ema_product_number": "EMEA/H/C/005873", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0008", "international_non_proprietary_name_common_name": "pirfenidone", "active_substance": "Pirfenidone", "therapeutic_area_mesh": "Idiopathic Pulmonary Fibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Axunio Pharma GmbH", "european_commission_decision_date": "18/04/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/04/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "28/06/2022", "last_updated_date": "25/04/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pirfenidone-axunio" }, { "category": "Human", "name_of_medicine": "Sifrol", "ema_product_number": "EMEA/H/C/000133", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2626", "international_non_proprietary_name_common_name": "pramipexole", "active_substance": "pramipexole dihydrochloride monohydrate", "therapeutic_area_mesh": "Restless Legs Syndrome;Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sifrol is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, though to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). Sifrol is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "14/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/06/1997", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/10/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "08/02/2018", "last_updated_date": "25/04/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sifrol" }, { "category": "Human", "name_of_medicine": "Eladynos", "ema_product_number": "EMEA/H/C/005928", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0008", "international_non_proprietary_name_common_name": "abaloparatide", "active_substance": "abaloparatide", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal;Osteoporosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women at increased risk of fracture.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Theramex Ireland Limited", "european_commission_decision_date": "11/04/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/12/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "22/12/2022", "last_updated_date": "12/04/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eladynos" }, { "category": "Veterinary", "name_of_medicine": "Tessie", "ema_product_number": "EMEA/V/C/005427", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tasipimidine", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Other hypnotics and sedatives", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/06/2021", "last_updated_date": "11/04/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/tessie" }, { "category": "Human", "name_of_medicine": "Ranexa (previously Latixa)", "ema_product_number": "EMEA/H/C/000805", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0068", "international_non_proprietary_name_common_name": "ranolazine", "active_substance": "ranolazine", "therapeutic_area_mesh": "Angina Pectoris", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01EB18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Menarini International Operations Luxembourg S.A. (MIOL)", "european_commission_decision_date": "10/08/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/07/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "03/08/2017", "last_updated_date": "10/04/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ranexa" }, { "category": "Human", "name_of_medicine": "Lonsurf", "ema_product_number": "EMEA/H/C/003897", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0026", "international_non_proprietary_name_common_name": "trifluridine;tipiracil", "active_substance": "trifluridine;tipiracil hydrochloride", "therapeutic_area_mesh": "Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC59", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Colorectal cancer Lonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents. Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti EGFR agents Gastric cancer Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "26/07/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/02/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/04/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "14/08/2017", "last_updated_date": "05/04/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lonsurf" }, { "category": "Human", "name_of_medicine": "Niapelf", "ema_product_number": "EMEA/H/C/006185", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "paliperidone", "active_substance": "paliperidone palmitate", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "indicated for maintenance treatment of schizophrenia in adult patients stabilised withpaliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Niapelf may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed. ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Neuraxpharm Pharmaceuticals S.L.", "european_commission_decision_date": "21/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/01/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/03/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "04/04/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/niapelf" }, { "category": "Human", "name_of_medicine": "Ertapenem SUN", "ema_product_number": "EMEA/H/C/005815", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0003", "international_non_proprietary_name_common_name": "ertapenem", "active_substance": "ertapenem sodium", "therapeutic_area_mesh": "Bacterial Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "ertapenem", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment Ertapenem SUN is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1): Intra-abdominal infections Community acquired pneumonia Acute gynaecological infections Diabetic foot infections of the skin and soft tissue (see section 4.4) Prevention Ertapenem SUN is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SUN Pharmaceutical Industries (Europe) B.V.", "european_commission_decision_date": "02/04/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/07/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "17/05/2022", "last_updated_date": "03/04/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ertapenem-sun" }, { "category": "Veterinary", "name_of_medicine": "Nobivac LoVo L4", "ema_product_number": "EMEA/V/C/005628", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "canine leptospirosis vaccine (inactivated)", "active_substance": "Leptospira interrogans, serogroup Australis, serovar Bratislava, strain As-05-073, Inactivated,Leptospira interrogans, serogroup Canicola, serovar Portland-vere, strain Ca-12-000, Inactivated,Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Copenhageni, strain Ic-02-001, Inactivated,Leptospira kirschneri, serogroup Grippotyphosa, serovar Dadas, strain GR-01-005, Inactivated,", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/10/2023", "last_updated_date": "03/04/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobivac-lovo-l4" }, { "category": "Veterinary", "name_of_medicine": "Bovilis Nasalgen-C", "ema_product_number": "EMEA/V/C/005906", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bovine coronavirus, strain CA25, live", "active_substance": "bovine coronavirus, strain CA25, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae;Live viral vaccines;bovine coronavirus", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/02/2023", "last_updated_date": "03/04/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bovilis-nasalgen-c" }, { "category": "Veterinary", "name_of_medicine": "Bovilis Cryptium", "ema_product_number": "EMEA/V/C/006045", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "cryptosporidium parvum, glycoprotein gp40", "active_substance": "Cryptosporidium parvum, glycoprotein gp40", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae;Inactivated parasitic vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/10/2023", "last_updated_date": "03/04/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bovilis-cryptium" }, { "category": "Veterinary", "name_of_medicine": "Poulvac Procerta HVT-IBD", "ema_product_number": "EMEA/V/C/006000", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "turkey herpes virus, strain FC-126, expressing infectious bursal disease virus VP2 protein, live", "active_substance": "turkey herpes virus, strain HVT-IBD, expressing infectious bursal disease virus VP2 protein, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live viral vaccines;Avian herpes virus (marek’s disease) + avian infectious bursal disease virus (gumboro disease)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/09/2023", "last_updated_date": "03/04/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/poulvac-procerta-hvt-ibd" }, { "category": "Human", "name_of_medicine": "Ximluci", "ema_product_number": "EMEA/H/C/005617", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0009", "international_non_proprietary_name_common_name": "ranibizumab", "active_substance": "ranibizumab", "therapeutic_area_mesh": "Wet Macular Degeneration;Macular Edema;Diabetic Retinopathy;Diabetes Complications", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ximluci is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative diabetic retinopathy (PDR) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) The treatment of visual impairment due to choroidal neovascularisation (CNV)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "STADA Arzneimittel AG", "european_commission_decision_date": "26/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "14/09/2022", "last_updated_date": "26/03/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ximluci" }, { "category": "Human", "name_of_medicine": "Clopidogrel ratiopharm", "ema_product_number": "EMEA/H/C/004006", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0024/G", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrogen sulfate)", "therapeutic_area_mesh": "Myocardial Infarction;Acute Coronary Syndrome;Peripheral Vascular Diseases;Stroke", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillationIn adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "21/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/12/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/02/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "13/04/2018", "last_updated_date": "26/03/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-ratiopharm" }, { "category": "Human", "name_of_medicine": "Cuprior", "ema_product_number": "EMEA/H/C/004005", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0029", "international_non_proprietary_name_common_name": "trientine", "active_substance": "trientine tetrahydrochloride", "therapeutic_area_mesh": "Hepatolenticular Degeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cuprior is indicated for the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Orphalan", "european_commission_decision_date": "25/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/04/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/09/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "05/09/2017", "last_updated_date": "26/03/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cuprior" }, { "category": "Human", "name_of_medicine": "Exblifep", "ema_product_number": "EMEA/H/C/005431", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "cefepime;enmetazobactam", "active_substance": "cefepime dihydrochloride monohydrate;Enmetazobactam", "therapeutic_area_mesh": "Urinary Tract Infections;Pyelonephritis;Healthcare-Associated Pneumonia;Pneumonia, Ventilator-Associated", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01DE51", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Exblifep is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1): - Complicated urinary tract infections (cUTI), including pyelonephritis - Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Advanz Pharma Limited", "european_commission_decision_date": "21/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/01/2024", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2024", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/01/2024", "last_updated_date": "22/03/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exblifep" }, { "category": "Human", "name_of_medicine": "Vijoice", "ema_product_number": "EMEA/H/C/005468", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "alpelisib", "active_substance": "alpelisib", "therapeutic_area_mesh": "Genetic Diseases, Inborn;Growth Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EM03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with severe manifestations of PIK3CA-related overgrowth spectrum", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "30/10/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/11/2023", "last_updated_date": "14/03/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vijoice-w" }, { "category": "Human", "name_of_medicine": "Sustiva", "ema_product_number": "EMEA/H/C/000249", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0161", "international_non_proprietary_name_common_name": "efavirenz", "active_substance": "efavirenz", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "23/05/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/05/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/02/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "48", "first_published_date": "15/12/2017", "last_updated_date": "14/03/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sustiva" }, { "category": "Human", "name_of_medicine": "Pramipexole Accord", "ema_product_number": "EMEA/H/C/002291", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0017", "international_non_proprietary_name_common_name": "pramipexole", "active_substance": "pramipexole dihydrochloride monohydrate", "therapeutic_area_mesh": "Parkinson Disease;Restless Legs Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "20/11/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/09/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/04/2022", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "24/10/2017", "last_updated_date": "11/03/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pramipexole-accord" }, { "category": "Veterinary", "name_of_medicine": "Innovax-ILT-IBD", "ema_product_number": "EMEA/V/C/005905", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "turkey herpes virus, expressing infectious bursal disease virus and avian infectious laryngotracheitis virus, strain HVT/IBD/ILT, live", "active_substance": "turkey herpes virus, expressing infectious bursal disease virus and avian infectious laryngotracheitis virus, strain HVT/IBD/ILT, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live viral vaccines;Avian herpes virus (marek's disease);avian infectious laryngotracheitis virus;avian infectious bursal disease virus (gumboro disease)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/03/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/innovax-ilt-ibd" }, { "category": "Veterinary", "name_of_medicine": "Prevexxion RN+HVT", "ema_product_number": "EMEA/V/C/006146", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Marek’s disease virus, strain RN1250, live;turkey herpesvirus, strain FC126, live", "active_substance": "Marek’s disease virus, strain RN1250, live;turkey herpesvirus, strain FC126, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live viral vaccines;Avian herpes virus (marek's disease)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/03/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/prevexxion-rnhvt" }, { "category": "Veterinary", "name_of_medicine": "Eurican L4", "ema_product_number": "EMEA/V/C/005944", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "inactivated immunological veterinary medicinal product containing Leptospira interrogans, serogroup Canicola, serovar Canicola, strain 16070, L. interrogans, serogroup icterohaemorrhagiae, serovar icterohaemorrhagiae, strain 16069, L. interrogans, serogroup Grippotyphosa, serovar Grippotyphosa, strain Grippo Mal 1540, L. interrogans, serogroup Australis, serovar Bratislava, strain", "active_substance": "inactivated immunological veterinary medicinal product containing Leptospira interrogans, serogroup Canicola, serovar Canicola, strain 16070, L. interrogans, serogroup icterohaemorrhagiae, serovar icterohaemorrhagiae, strain 16069, L. interrogans, serogroup Grippotyphosa, serovar Grippotyphosa, strain Grippo Mal 1540, L. interrogans, serogroup Australis, serovar Bratislava, strain", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for canidae;Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia);leptospira", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/03/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/eurican-l4" }, { "category": "Veterinary", "name_of_medicine": "Yurvac RHD", "ema_product_number": "EMEA/V/C/005992", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rabbit haemorrhagic disease virus, capsid protein antigen, recombinant", "active_substance": "rabbit haemorrhagic disease virus, capsid protein antigen, recombinant", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for leporidae;Other inactivated vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/03/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/yurvac-rhd" }, { "category": "Human", "name_of_medicine": "Zalasta", "ema_product_number": "EMEA/H/C/000792", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0044/G", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka", "european_commission_decision_date": "01/03/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/09/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "19/01/2018", "last_updated_date": "08/03/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zalasta" }, { "category": "Human", "name_of_medicine": "Apealea", "ema_product_number": "EMEA/H/C/004154", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0017", "international_non_proprietary_name_common_name": "paclitaxel", "active_substance": "paclitaxel", "therapeutic_area_mesh": "Ovarian Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents;Taxanes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum?sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Inceptua AB", "european_commission_decision_date": "11/09/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/11/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/02/2024", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "05/12/2018", "last_updated_date": "06/03/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/apealea" }, { "category": "Human", "name_of_medicine": "Clopidogrel Teva (hydrogen sulphate)", "ema_product_number": "EMEA/H/C/001053", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0059/G", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrogen sulfate)", "therapeutic_area_mesh": "Acute Coronary Syndrome;Peripheral Vascular Diseases;Myocardial Infarction;Stroke", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Secondary prevention of atherothrombotic eventsClopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome:- Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillationIn adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "08/02/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/05/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "04/12/2017", "last_updated_date": "29/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-teva-hydrogen-sulphate" }, { "category": "Human", "name_of_medicine": "Fuzeon", "ema_product_number": "EMEA/H/C/000514", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0065", "international_non_proprietary_name_common_name": "enfuvirtide", "active_substance": "enfuvirtide", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse-transcriptase inhibitors and nucleoside reverse-transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens. In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "16/10/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/05/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "06/04/2018", "last_updated_date": "23/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fuzeon" }, { "category": "Veterinary", "name_of_medicine": "HorStem", "ema_product_number": "EMEA/V/C/004265", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "equine umbilical cord mesenchymal stem cells", "active_substance": "equine umbilical cord mesenchymal stem cells", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Other drugs for disorders of the musculo-skeletal system", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/09/2019", "last_updated_date": "19/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/horstem" }, { "category": "Human", "name_of_medicine": "Lonquex", "ema_product_number": "EMEA/H/C/002556", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0080", "international_non_proprietary_name_common_name": "lipegfilgrastim", "active_substance": "lipegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants;Colony stimulating factors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "26/10/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/07/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "22/02/2018", "last_updated_date": "19/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lonquex" }, { "category": "Human", "name_of_medicine": "Mulpleo (previously Lusutrombopag Shionogi)", "ema_product_number": "EMEA/H/C/004720", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0017/G", "international_non_proprietary_name_common_name": "lusutrombopag", "active_substance": "Lusutrombopag", "therapeutic_area_mesh": "Thrombocytopenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Shionogi B.V.", "european_commission_decision_date": "05/01/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/12/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/02/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "14/03/2019", "last_updated_date": "16/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mulpleo" }, { "category": "Veterinary", "name_of_medicine": "Prolevare", "ema_product_number": "EMEA/V/C/006117", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "oclacitinib maleate", "active_substance": "oclacitinib maleate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Agents for dermatitis, excluding corticosteroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/02/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/prolevare" }, { "category": "Veterinary", "name_of_medicine": "CircoMax", "ema_product_number": "EMEA/V/C/005185", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "porcine circovirus vaccine (inactivated recombinant)", "active_substance": "recombinant chimeric porcine circovirus 1 containing the porcine circovirus 2a open reading frame 2 protein, inactivated,Recombinant chimeric porcine circovirus 1 containing the porcine circovirus 2b open reading frame 2 protein, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/02/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/circomax" }, { "category": "Veterinary", "name_of_medicine": "Brucellin Aquilon", "ema_product_number": "EMEA/V/C/005577", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "Brucella abortus, strain AQ1302, protein extract", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "In vivo diagnostic preparations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/12/2022", "last_updated_date": "15/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/brucellin-aquilon" }, { "category": "Veterinary", "name_of_medicine": "Vectormune ND", "ema_product_number": "EMEA/V/C/003829", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Newcastle disease and Marek’s disease vaccine (live recombinant)", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live viral vaccines;Domestic fowl", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/07/2018", "last_updated_date": "15/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vectormune-nd" }, { "category": "Veterinary", "name_of_medicine": "AdTab (previously Lotilaner Elanco)", "ema_product_number": "EMEA/V/C/006030", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "lotilaner", "active_substance": "lotilaner", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for systemic use;Isoxazolines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/07/2022", "last_updated_date": "15/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/adtab" }, { "category": "Human", "name_of_medicine": "Catiolanze", "ema_product_number": "EMEA/H/C/005933", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0002", "international_non_proprietary_name_common_name": "latanoprost", "active_substance": "Latanoprost", "therapeutic_area_mesh": "Glaucoma, Open-Angle", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01EE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Catiolanze is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension. Catiolanze is indicated for the reduction of elevated IOP in children from 4 years of age and adolescents with elevated IOP and paediatric glaucoma.  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Santen Oy", "european_commission_decision_date": "09/02/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "15/09/2023", "last_updated_date": "13/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/catiolanze" }, { "category": "Veterinary", "name_of_medicine": "Mometamax Ultra", "ema_product_number": "EMEA/V/C/004987", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "gentamicin;posaconazole;mometasone furoate", "active_substance": "gentamicin;mometasone furoate;posaconazole", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Otologicals;Corticosteroids;Antiinfectives", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/02/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/mometamax-ultra" }, { "category": "Veterinary", "name_of_medicine": "Evanovo", "ema_product_number": "EMEA/V/C/005819", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "Eimeria acervulina, strain 044, live;Eimeria maxima, strain 013, live;Eimeria praecox, strain 007, live;Eimeria tenella, strain 004, live", "active_substance": "Eimeria acervulina, strain 044, live;Eimeria maxima, strain 013, live;Eimeria praecox, strain 007, Live;Eimeria tenella, strain 004, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live parasitic vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/02/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/evanovo" }, { "category": "Veterinary", "name_of_medicine": "DogStem", "ema_product_number": "EMEA/V/C/005829", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "equine umbilical cord-derived mesenchymal stem cells", "active_substance": "equine umbilical cord-derived mesenchymal stem cells", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Other drugs for disorders of the musculo-skeletal system", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/02/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/dogstem" }, { "category": "Veterinary", "name_of_medicine": "Cortaderm", "ema_product_number": "EMEA/V/C/005579", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "hydrocortisone aceponate", "active_substance": "hydrocortisone aceponate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Corticosteroids, dermatological preparations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/02/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cortaderm" }, { "category": "Veterinary", "name_of_medicine": "Coxatab", "ema_product_number": "EMEA/V/C/005816", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "firocoxib", "active_substance": "firocoxib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products, non-steroids", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/02/2024", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/coxatab" }, { "category": "Human", "name_of_medicine": "Ambirix", "ema_product_number": "EMEA/H/C/000426", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2594/G", "international_non_proprietary_name_common_name": "hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)", "active_substance": "hepatitis A virus (inactivated);hepatitis B surface antigen", "therapeutic_area_mesh": "Hepatitis B;Hepatitis A;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BC20", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ambirix is for use in non-immune persons from one year up to and including 15 years of age for protection against hepatitis-A and hepatitis-B infection. Protection against hepatitis-B infections may not be obtained until after the second dose. Therefore: Ambirix should be used only when there is a relatively low risk of hepatitis-B infection during the vaccination course; it is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "01/02/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/08/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "27/10/2017", "last_updated_date": "08/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ambirix" }, { "category": "Human", "name_of_medicine": "Sugammadex Lorien", "ema_product_number": "EMEA/H/C/006115", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "sugammadex sodium", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AB35", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "reversal of neuromuscular blockade induced by rocuronium or vecuronium ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "LABORATORIOS LORIEN, S.L", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "28/09/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/10/2023", "last_updated_date": "08/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sugammadex-lorien" }, { "category": "Human", "name_of_medicine": "Twinrix Adult", "ema_product_number": "EMEA/H/C/000112", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2594/G", "international_non_proprietary_name_common_name": "hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)", "active_substance": "hepatitis A virus (inactivated);hepatitis B surface antigen", "therapeutic_area_mesh": "Hepatitis B;Hepatitis A;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BC20", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "01/02/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "27/10/2017", "last_updated_date": "07/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/twinrix-adult" }, { "category": "Human", "name_of_medicine": "Twinrix Paediatric", "ema_product_number": "EMEA/H/C/000129", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2594/G", "international_non_proprietary_name_common_name": "hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)", "active_substance": "hepatitis A virus (inactivated);hepatitis B surface antigen", "therapeutic_area_mesh": "Immunization;Hepatitis B;Hepatitis A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BC20", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Twinrix Paediatric is indicated for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis-A and hepatitis-B infection.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "01/02/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/02/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "27/10/2017", "last_updated_date": "07/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/twinrix-paediatric" }, { "category": "Human", "name_of_medicine": "Actraphane", "ema_product_number": "EMEA/H/C/000427", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0096", "international_non_proprietary_name_common_name": "insulin human (rDNA)", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "02/02/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2002", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/10/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "26/04/2018", "last_updated_date": "02/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/actraphane" }, { "category": "Human", "name_of_medicine": "Albrioza", "ema_product_number": "EMEA/H/C/005901", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "sodium phenylbutyrate;ursodoxicoltaurine", "active_substance": "sodium phenylbutyrate;ursodoxicoltaurine", "therapeutic_area_mesh": "Amyotrophic Lateral Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of amyotrophic lateral sclerosis (ALS)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amylyx Pharmaceuticals EMEA B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/10/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "05/01/2024", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/06/2023", "last_updated_date": "01/02/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/albrioza" }, { "category": "Veterinary", "name_of_medicine": "Chanaxin", "ema_product_number": "EMEA/V/C/005606", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tulathromycin", "active_substance": "tulathromycin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use;Macrolides", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/01/2024", "last_updated_date": "30/01/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/chanaxin" }, { "category": "Human", "name_of_medicine": "Mixtard", "ema_product_number": "EMEA/H/C/000428", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0097", "international_non_proprietary_name_common_name": "insulin human (rDNA)", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "24/01/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2002", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/10/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "26/04/2018", "last_updated_date": "24/01/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mixtard" }, { "category": "Human", "name_of_medicine": "Nemdatine", "ema_product_number": "EMEA/H/C/002680", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0020/G", "international_non_proprietary_name_common_name": "memantine", "active_substance": "memantine", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics;Other anti-dementia drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with moderate to severe Alzheimer’s disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "16/01/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/02/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/04/2013", "refusal_of_marketing_authorisation_date": "22/02/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "08/01/2018", "last_updated_date": "17/01/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nemdatine" }, { "category": "Human", "name_of_medicine": "Tegsedi", "ema_product_number": "EMEA/H/C/004782", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0038", "international_non_proprietary_name_common_name": "inotersen", "active_substance": "inotersen sodium", "therapeutic_area_mesh": "Amyloidosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Akcea Therapeutics Ireland Limited", "european_commission_decision_date": "30/11/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/05/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/07/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "06/07/2018", "last_updated_date": "17/01/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tegsedi" }, { "category": "Human", "name_of_medicine": "Intrarosa", "ema_product_number": "EMEA/H/C/004138", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "S/0044", "international_non_proprietary_name_common_name": "prasterone", "active_substance": "prasterone", "therapeutic_area_mesh": "Postmenopause", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03XX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Endoceutics S.A.", "european_commission_decision_date": "07/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "08/01/2018", "last_updated_date": "15/01/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/intrarosa" }, { "category": "Human", "name_of_medicine": "Flebogamma DIF (previously Flebogammadif)", "ema_product_number": "EMEA/H/C/000781", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0077/G", "international_non_proprietary_name_common_name": "human normal immunoglobulin", "active_substance": "human normal immunoglobulin", "therapeutic_area_mesh": "Mucocutaneous Lymph Node Syndrome;Guillain-Barre Syndrome;Bone Marrow Transplantation;Purpura, Thrombocytopenic, Idiopathic;Immunologic Deficiency Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Replacement therapy in adults, children and adolescents (0-18 years) in: primary immunodeficiency syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, children and adolescents (0-18 years) in: primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Instituto Grifols S.A.", "european_commission_decision_date": "30/10/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/07/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "29/06/2017", "last_updated_date": "11/01/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/flebogamma-dif" }, { "category": "Human", "name_of_medicine": "Azacitidine betapharm", "ema_product_number": "EMEA/H/C/005075", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0017", "international_non_proprietary_name_common_name": "azacitidine", "active_substance": "azacitidine", "therapeutic_area_mesh": "Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Azacitidine betapharm is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 % to 29 % marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 % to 30 % blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification, AML with > 30 % marrow blasts according to the WHO classification.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "betapharm Arzneimittel GmbH", "european_commission_decision_date": "09/01/2024", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/03/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "20/11/2020", "last_updated_date": "10/01/2024", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/azacitidine-betapharm" }, { "category": "Human", "name_of_medicine": "Dimethyl fumarate Teva", "ema_product_number": "EMEA/H/C/005963", "medicine_status": "Revoked", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dimethyl fumarate", "active_substance": "dimethyl fumarate", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dimethyl fumarate Teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva GmbH", "european_commission_decision_date": "12/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/12/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/12/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/10/2022", "last_updated_date": "22/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-teva" }, { "category": "Human", "name_of_medicine": "Dimethyl fumarate Neuraxpharm", "ema_product_number": "EMEA/H/C/006039", "medicine_status": "Revoked", "opinion_status": "", "latest_procedure_affecting_product_information": "EMEA/H/C/006039", "international_non_proprietary_name_common_name": "dimethyl fumarate", "active_substance": "dimethyl fumarate", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dimethyl fumarate Neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratorios Lesvi S.L.", "european_commission_decision_date": "13/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/05/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/12/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "22/02/2022", "last_updated_date": "22/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-neuraxpharm-0" }, { "category": "Human", "name_of_medicine": "Dimethyl fumarate Accord", "ema_product_number": "EMEA/H/C/005950", "medicine_status": "Revoked", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dimethyl fumarate", "active_substance": "dimethyl fumarate", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "13/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/02/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/12/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/02/2023", "last_updated_date": "22/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-accord-0" }, { "category": "Human", "name_of_medicine": "Dimethyl fumarate Polpharma", "ema_product_number": "EMEA/H/C/005955", "medicine_status": "Revoked", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dimethyl fumarate", "active_substance": "dimethyl fumarate", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.", "european_commission_decision_date": "13/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/05/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/12/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "22/02/2022", "last_updated_date": "22/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-polpharma" }, { "category": "Human", "name_of_medicine": "Dimethyl fumarate Mylan", "ema_product_number": "EMEA/H/C/005956", "medicine_status": "Revoked", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dimethyl fumarate", "active_substance": "dimethyl fumarate", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dimethyl fumarate Mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Ireland Limited", "european_commission_decision_date": "13/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/05/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/12/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "22/02/2022", "last_updated_date": "22/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-mylan-0" }, { "category": "Human", "name_of_medicine": "Defitelio", "ema_product_number": "EMEA/H/C/002393", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0063", "international_non_proprietary_name_common_name": "defibrotide", "active_substance": "defibrotide", "therapeutic_area_mesh": "Hepatic Veno-Occlusive Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. It is indicated in adults and in adolescents, children and infants over 1 month of age.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gentium S.r.l.", "european_commission_decision_date": "19/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/10/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "21/04/2017", "last_updated_date": "20/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/defitelio" }, { "category": "Human", "name_of_medicine": "Clopidogrel Taw Pharma (previously Clopidogrel Mylan)", "ema_product_number": "EMEA/H/C/001134", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0049/G", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel hydrochloride", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction;Acute Coronary Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Secondary prevention of atherothrombotic events Clopidogrel is indicated in:  \t\t\t- Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. \t\t\t- Adult patients suffering from acute coronary syndrome: \t\t\t   - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). \t\t\t    - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. In patients with moderate to high-risk Transient Ischaemic Attack (TIA) or minor Ischaemic Stroke (IS) \t\t\tClopidogrel in combination with ASA is indicated in: \t\t\t- Adult patients with moderate to high-risk TIA (ABCD2  score ?4) or minor IS (NIHSS  ?3) within 24 hours of either the TIA or IS event.  Prevention of atherothrombotic and thromboembolic events in atrial fibrillation \t\t\tIn adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Taw Pharma (Ireland) Limited", "european_commission_decision_date": "18/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "13/04/2018", "last_updated_date": "19/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-taw-pharma" }, { "category": "Human", "name_of_medicine": "Dyrupeg", "ema_product_number": "EMEA/H/C/005810", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "pegfilgrastim", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neutropenia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CuraTeQ Biologics s.r.o", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "08/06/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/06/2023", "last_updated_date": "14/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dyrupeg" }, { "category": "Human", "name_of_medicine": "Vantobra (previously Tobramycin PARI)", "ema_product_number": "EMEA/H/C/005086", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/10", "international_non_proprietary_name_common_name": "tobramycin", "active_substance": "tobramycin", "therapeutic_area_mesh": "Respiratory Tract Infections;Cystic Fibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01GB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pari Pharma GmbH", "european_commission_decision_date": "14/10/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/02/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "17/04/2019", "last_updated_date": "13/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vantobra-previously-tobramycin-pari" }, { "category": "Human", "name_of_medicine": "Jesduvroq", "ema_product_number": "EMEA/H/C/005746", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "daprodustat", "active_substance": "daprodustat", "therapeutic_area_mesh": "Renal Insufficiency, Chronic;Anemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of anaemia associated with chronic kidney disease (CKD) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "12/07/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/07/2023", "last_updated_date": "13/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jesduvroq" }, { "category": "Human", "name_of_medicine": "Brineura", "ema_product_number": "EMEA/H/C/004065", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0039", "international_non_proprietary_name_common_name": "cerliponase alfa", "active_substance": "cerliponase alfa", "therapeutic_area_mesh": "Neuronal Ceroid-Lipofuscinoses", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency", "accelerated_assessment": "Yes", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioMarin International Limited", "european_commission_decision_date": "11/12/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/04/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/05/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "07/12/2017", "last_updated_date": "12/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/brineura" }, { "category": "Human", "name_of_medicine": "Ivozall", "ema_product_number": "EMEA/H/C/005039", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0006", "international_non_proprietary_name_common_name": "clofarabine", "active_substance": "clofarabine", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ORPHELIA Pharma", "european_commission_decision_date": "06/03/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/10/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "22/11/2019", "last_updated_date": "07/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ivozall" }, { "category": "Human", "name_of_medicine": "Pylobactell", "ema_product_number": "EMEA/H/C/000151", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0020", "international_non_proprietary_name_common_name": "13C-urea", "active_substance": "urea (13C)", "therapeutic_area_mesh": "Breath Tests;Helicobacter Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V04CX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. For in vivo diagnosis of gastroduodenal Helicobacter pylori (H. pylori) infection.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Richen Europe S.R.L", "european_commission_decision_date": "28/07/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/05/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "03/03/2017", "last_updated_date": "04/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pylobactell" }, { "category": "Human", "name_of_medicine": "COVID-19 Vaccine (inactivated, adjuvanted) Valneva", "ema_product_number": "EMEA/H/C/006019", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0004", "international_non_proprietary_name_common_name": "COVID-19 vaccine (inactivated, adjuvanted, adsorbed)", "active_substance": "COVID-19 vaccine (inactivated, adjuvanted, adsorbed)", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "COVID-19 Vaccine (inactivated, adjuvanted) Valneva is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age.  The use of this vaccine should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Valneva Austria GmbH", "european_commission_decision_date": "12/10/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/06/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "12/10/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "27/06/2022", "last_updated_date": "01/12/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-inactivated-adjuvanted-valneva" }, { "category": "Human", "name_of_medicine": "Betaferon", "ema_product_number": "EMEA/H/C/000081", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0147", "international_non_proprietary_name_common_name": "interferon beta-1b", "active_substance": "interferon beta-1b", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Betaferon is indicated for the treatment of patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis; patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years; patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG ", "european_commission_decision_date": "23/11/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "12/07/1995", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/11/1995", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "28/07/2017", "last_updated_date": "23/11/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/betaferon" }, { "category": "Human", "name_of_medicine": "Jivadco", "ema_product_number": "EMEA/H/C/005654", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "trastuzumab duocarmazine", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of HER2 (Human Epidermal Growth Factor Receptor 2)-positive metastatic breast cancer", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "12/09/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/10/2023", "last_updated_date": "23/11/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jivadco" }, { "category": "Human", "name_of_medicine": "Zynrelef", "ema_product_number": "EMEA/H/C/005205", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010880/202303", "international_non_proprietary_name_common_name": "bupivacaine;meloxicam", "active_substance": "bupivacaine;meloxicam", "therapeutic_area_mesh": "Pain, Postoperative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N01B", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anesthetics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zynrelef is indicated for treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Heron Therapeutics, B.V.", "european_commission_decision_date": "05/10/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/09/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "05/10/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "06/10/2020", "last_updated_date": "22/11/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zynrelef" }, { "category": "Human", "name_of_medicine": "Spectrila", "ema_product_number": "EMEA/H/C/002661", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0032/G", "international_non_proprietary_name_common_name": "asparaginase", "active_substance": "asparaginase", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Medac Gesellschaft fuer klinische Spezialpraeparate mbH", "european_commission_decision_date": "09/03/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/01/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "18/06/2018", "last_updated_date": "20/11/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/spectrila" }, { "category": "Human", "name_of_medicine": "Sildenafil Actavis", "ema_product_number": "EMEA/H/C/001090", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0026", "international_non_proprietary_name_common_name": "sildenafil", "active_substance": "sildenafil", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil Actavis to be effective, sexual stimulation is required.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "10/11/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/12/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "06/04/2018", "last_updated_date": "13/11/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sildenafil-actavis" }, { "category": "Human", "name_of_medicine": "Gefzuris", "ema_product_number": "EMEA/H/C/005884", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "gefapixant", "active_substance": "gefapixant", "therapeutic_area_mesh": "Cough", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R05DB29", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "gefapixant", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of refractory or unexplained chronic cough.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "14/07/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/07/2023", "last_updated_date": "08/11/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gefzuris" }, { "category": "Human", "name_of_medicine": "Degarelix Accord", "ema_product_number": "EMEA/H/C/006048", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "degarelix", "active_substance": "degarelix acetate", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hormone antagonists and related agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Degarelix Accord is a gonadotrophin releasing hormone (GnRH) antagonist indicated: for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "29/09/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/09/2023", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/07/2023", "last_updated_date": "08/11/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/degarelix-accord" }, { "category": "Human", "name_of_medicine": "Lutholaz", "ema_product_number": "EMEA/H/C/005587", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neutropenia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "YES Pharmaceutical Development Services GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "19/07/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/08/2023", "last_updated_date": "07/11/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lutholaz" }, { "category": "Human", "name_of_medicine": "Rebetol", "ema_product_number": "EMEA/H/C/000246", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0093/G", "international_non_proprietary_name_common_name": "ribavirin", "active_substance": "ribavirin", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AP01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use;Antivirals for treatment of HCV infections", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp and Dohme B.V", "european_commission_decision_date": "24/11/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/05/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/10/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "03/02/2017", "last_updated_date": "07/11/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rebetol" }, { "category": "Veterinary", "name_of_medicine": "CaniLeish", "ema_product_number": "EMEA/V/C/002232", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0004", "international_non_proprietary_name_common_name": "Leishmania infantum excreted secreted proteins", "active_substance": "Leishmania infantum excreted secreted proteins", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI07AO", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "For the active immunisation of Leishmania-negative dogs from six months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum. The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure in zones with high infection pressure. Onset of immunity: 4 weeks after the primary vaccination course. Duration of immunity: 1 year after the last re-vaccination.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Virbac S.A.", "european_commission_decision_date": "07/01/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/03/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "07/01/2016", "last_updated_date": "24/10/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/canileish" }, { "category": "Human", "name_of_medicine": "Vivjoa", "ema_product_number": "EMEA/H/C/005682", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "oteseconazole", "active_substance": "oteseconazole", "therapeutic_area_mesh": "Candidiasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "24/08/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/09/2023", "last_updated_date": "23/10/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vivjoa" }, { "category": "Human", "name_of_medicine": "Thiotepa Riemser", "ema_product_number": "EMEA/H/C/005434", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0006", "international_non_proprietary_name_common_name": "thiotepa", "active_substance": "thiotepa", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation;Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients. Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Esteve Pharmaceuticals GmbH", "european_commission_decision_date": "18/10/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "30/04/2021", "last_updated_date": "23/10/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/thiotepa-riemser" }, { "category": "Human", "name_of_medicine": "Imatinib Koanaa", "ema_product_number": "EMEA/H/C/005595", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "imatinib", "active_substance": "imatinib mesilate", "therapeutic_area_mesh": "Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Myelodysplastic-Myeloproliferative Diseases;Hypereosinophilic Syndrome;Dermatofibrosarcoma;Gastrointestinal Stromal Tumors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imatinib Koanaa is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. adult patients with relapsed or refractory Ph+ ALL as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR? rearrangement. The effect of Imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib Koanaa is indicated for the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. In adult and paediatric patients, the effectiveness of Imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with Imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Koanaa Healthcare GmbH", "european_commission_decision_date": "22/09/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/07/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/09/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "31/08/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/10/2021", "last_updated_date": "19/10/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imatinib-koanaa" }, { "category": "Human", "name_of_medicine": "Plenadren", "ema_product_number": "EMEA/H/C/002185", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0043", "international_non_proprietary_name_common_name": "hydrocortisone", "active_substance": "hydrocortisone", "therapeutic_area_mesh": "Adrenal Insufficiency", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H02AB09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Corticosteroids for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adrenal insufficiency in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland Branch", "european_commission_decision_date": "28/09/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/11/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "15/05/2018", "last_updated_date": "13/10/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/plenadren" }, { "category": "Human", "name_of_medicine": "Pregabalin Sandoz GmbH", "ema_product_number": "EMEA/H/C/004070", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0032", "international_non_proprietary_name_common_name": "pregabalin", "active_substance": "pregabalin", "therapeutic_area_mesh": "Anxiety Disorders;Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Epilepsy Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "21/09/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/06/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "04/10/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "26/01/2018", "last_updated_date": "12/10/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pregabalin-sandoz-gmbh" }, { "category": "Human", "name_of_medicine": "Rekovelle", "ema_product_number": "EMEA/H/C/003994", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0037/G", "international_non_proprietary_name_common_name": "follitropin delta", "active_substance": "follitropin delta", "therapeutic_area_mesh": "Anovulation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03GA10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ferring Pharmaceuticals A/S", "european_commission_decision_date": "20/07/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/12/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "18/05/2017", "last_updated_date": "04/10/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rekovelle" }, { "category": "Human", "name_of_medicine": "Adakveo", "ema_product_number": "EMEA/H/C/004874", "medicine_status": "Revoked", "opinion_status": "", "latest_procedure_affecting_product_information": "004874/A20/0013", "international_non_proprietary_name_common_name": "crizanlizumab", "active_substance": "Crizanlizumab", "therapeutic_area_mesh": "Anemia, Sickle Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06AX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adakveo is indicated for the prevention of recurrent vaso occlusive crises (VOCs) in sickle cell disease patients aged 16 years and older. It can be given as an add on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "03/08/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/10/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "03/08/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "24/11/2020", "last_updated_date": "29/09/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adakveo" }, { "category": "Human", "name_of_medicine": "Eporatio", "ema_product_number": "EMEA/H/C/001033", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0052", "international_non_proprietary_name_common_name": "epoetin theta", "active_substance": "epoetin theta", "therapeutic_area_mesh": "Kidney Failure, Chronic;Anemia;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ratiopharm GmbH", "european_commission_decision_date": "26/09/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "23/03/2018", "last_updated_date": "27/09/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eporatio" }, { "category": "Human", "name_of_medicine": "Biopoin", "ema_product_number": "EMEA/H/C/001036", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0053", "international_non_proprietary_name_common_name": "epoetin theta", "active_substance": "epoetin theta", "therapeutic_area_mesh": "Kidney Failure, Chronic;Anemia;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva GmbH", "european_commission_decision_date": "26/09/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "23/03/2018", "last_updated_date": "27/09/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/biopoin" }, { "category": "Human", "name_of_medicine": "Vosevi", "ema_product_number": "EMEA/H/C/004350", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0059", "international_non_proprietary_name_common_name": "sofosbuvir;velpatasvir;voxilaprevi", "active_substance": "sofosbuvir;velpatasvir;voxilaprevi", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05A", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older and weighing at least 30 kg. (see sections 4.2, 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "07/08/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/06/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "14/06/2018", "last_updated_date": "27/09/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vosevi" }, { "category": "Human", "name_of_medicine": "Epclusa", "ema_product_number": "EMEA/H/C/004210", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0071", "international_non_proprietary_name_common_name": "sofosbuvir;velpatasvir", "active_substance": "sofosbuvir;velpatasvir", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05A", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "07/08/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/05/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/07/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "14/06/2018", "last_updated_date": "27/09/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/epclusa" }, { "category": "Human", "name_of_medicine": "Invirase", "ema_product_number": "EMEA/H/C/000113", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0139", "international_non_proprietary_name_common_name": "saquinavir", "active_substance": "saquinavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Invirase is indicated for the treatment of HIV-1-infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "10/03/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/10/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "16/08/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "50", "first_published_date": "13/08/2018", "last_updated_date": "25/09/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/invirase" }, { "category": "Human", "name_of_medicine": "Melatonin Neurim", "ema_product_number": "EMEA/H/C/005603", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0002", "international_non_proprietary_name_common_name": "melatonin", "active_substance": "melatonin", "therapeutic_area_mesh": "Sleep Initiation and Maintenance Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05CH01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Melatonin Neurim is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "RAD Neurim Pharmaceuticals EEC SARL", "european_commission_decision_date": "14/09/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/11/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "14/09/2022", "last_updated_date": "15/09/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/melatonin-neurim" }, { "category": "Human", "name_of_medicine": "Pandemic Influenza Vaccine H5N1 Baxter AG", "ema_product_number": "EMEA/H/C/001200", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0032", "international_non_proprietary_name_common_name": "pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)", "active_substance": "influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1)", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Resilience Biomanufacturing Ireland Limited", "european_commission_decision_date": "01/02/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/08/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "11/09/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "24/03/2017", "last_updated_date": "13/09/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pandemic-influenza-vaccine-h5n1-baxter-ag" }, { "category": "Human", "name_of_medicine": "Tandemact", "ema_product_number": "EMEA/H/C/000680", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0069/G", "international_non_proprietary_name_common_name": "pioglitazone;glimepiride", "active_substance": "pioglitazone;glimepiride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tandemact is indicated for the treatment of patients with type-2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CHEPLAPHARM Arzneimittel GmbH", "european_commission_decision_date": "07/09/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "30/11/2016", "last_updated_date": "13/09/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tandemact" }, { "category": "Veterinary", "name_of_medicine": "Nobivac Myxo-RHD", "ema_product_number": "EMEA/V/C/002004", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1348", "international_non_proprietary_name_common_name": "live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009", "active_substance": "live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009", "therapeutic_area_mesh": "", "species_veterinary": "Rabbits", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI08AD", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "For active immunisation of rabbits from five weeks of age onwards to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease. Onset of immunity: 3 weeks. Duration of immunity: 1 year.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "18/03/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/07/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/09/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "05/08/2016", "last_updated_date": "12/09/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobivac-myxo-rhd" }, { "category": "Human", "name_of_medicine": "Zefylti", "ema_product_number": "EMEA/H/C/005888", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "filgrastim", "active_substance": "filgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "filgrastim", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zefylti is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CuraTeQ Biologics s.r.o", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "08/06/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/06/2023", "last_updated_date": "30/08/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zefylti-0" }, { "category": "Human", "name_of_medicine": "NovoMix", "ema_product_number": "EMEA/H/C/000308", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0115", "international_non_proprietary_name_common_name": "insulin aspart", "active_substance": "insulin aspart", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AD05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "22/05/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/04/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/08/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "11/04/2018", "last_updated_date": "29/08/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/novomix" }, { "category": "Human", "name_of_medicine": "Actos", "ema_product_number": "EMEA/H/C/000285", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0088/G", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: as monotherapy: in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with: metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CHEPLAPHARM Arzneimittel GmbH", "european_commission_decision_date": "11/08/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/10/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "26/05/2016", "last_updated_date": "28/08/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/actos" }, { "category": "Human", "name_of_medicine": "Nexpovio", "ema_product_number": "EMEA/H/C/005127", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0016", "international_non_proprietary_name_common_name": "selinexor", "active_substance": "selinexor", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX66", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "NEXPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stemline Therapeutics B.V.", "european_commission_decision_date": "14/08/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/01/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "27/05/2021", "last_updated_date": "17/08/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nexpovio" }, { "category": "Human", "name_of_medicine": "Lagevrio", "ema_product_number": "EMEA/H/C/005789", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "molnupiravir", "active_substance": "molnupiravir", "therapeutic_area_mesh": "COVID-19 virus infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05A", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of coronavirus disease 2019 (COVID-19).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "21/06/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/06/2023", "last_updated_date": "09/08/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lagevrio" }, { "category": "Human", "name_of_medicine": "Lumevoq", "ema_product_number": "EMEA/H/C/005047", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "lenadogene nolparvovec", "active_substance": "lenadogene nolparvovec", "therapeutic_area_mesh": "Optic Atrophy, Hereditary, Leber", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lumevoq (lenadogene nolparvovec) is indicated for the treatment of patients with vision loss due to Leber Hereditary Optic Neuropathy (LHON) caused by a confirmed G11778A mutation in the ND4 mitochondrial gene (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GenSight Biologics S.A.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/04/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/04/2023", "last_updated_date": "08/08/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lumevoq" }, { "category": "Human", "name_of_medicine": "Busilvex", "ema_product_number": "EMEA/H/C/000472", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0035/G", "international_non_proprietary_name_common_name": "busulfan", "active_substance": "busulfan", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option. Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen. Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pierre Fabre Medicament", "european_commission_decision_date": "01/02/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/03/2003", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/07/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "24/05/2017", "last_updated_date": "04/08/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/busilvex" }, { "category": "Human", "name_of_medicine": "Sohonos", "ema_product_number": "EMEA/H/C/004867", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "palovarotene", "active_substance": "palovarotene", "therapeutic_area_mesh": "Myositis Ossificans", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of fibrodysplasia ossificans progressiva.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ipsen Pharma", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/05/2023", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "17/07/2023", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/07/2023", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sohonos" }, { "category": "Human", "name_of_medicine": "Vipidia", "ema_product_number": "EMEA/H/C/002182", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0035", "international_non_proprietary_name_common_name": "alogliptin benzoate", "active_substance": "alogliptin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BH04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Dipeptidyl peptidase 4 (DPP-4) inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "25/05/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "15/01/2015", "last_updated_date": "21/07/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vipidia" }, { "category": "Human", "name_of_medicine": "NutropinAq", "ema_product_number": "EMEA/H/C/000315", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0079", "international_non_proprietary_name_common_name": "somatropin", "active_substance": "somatropin", "therapeutic_area_mesh": "Turner Syndrome;Dwarfism, Pituitary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. Long-term treatment of growth failure associated with Turner syndrome. Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ipsen Pharma", "european_commission_decision_date": "20/07/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/02/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "22/02/2018", "last_updated_date": "20/07/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nutropinaq" }, { "category": "Human", "name_of_medicine": "Susvimo", "ema_product_number": "EMEA/H/C/005610", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ranibizumab", "active_substance": "ranibizumab", "therapeutic_area_mesh": "Wet Macular Degeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "ranibizumab", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neovascular age-related macular degeneration in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "02/05/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/05/2023", "last_updated_date": "18/07/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/susvimo" }, { "category": "Human", "name_of_medicine": "Fotivda", "ema_product_number": "EMEA/H/C/004131", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0026", "international_non_proprietary_name_common_name": "tivozanib hydrochloride monohydrate", "active_substance": "tivozanib", "therapeutic_area_mesh": "Carcinoma, Renal Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EK03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC. Treatment of advanced renal cell carcinoma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Recordati Netherlands B.V.", "european_commission_decision_date": "17/07/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/06/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/08/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "08/02/2018", "last_updated_date": "17/07/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fotivda" }, { "category": "Human", "name_of_medicine": "Iressa", "ema_product_number": "EMEA/H/C/001016", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0039/G", "international_non_proprietary_name_common_name": "gefitinib", "active_substance": "gefitinib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "14/07/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/06/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "23/04/2018", "last_updated_date": "17/07/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/iressa" }, { "category": "Human", "name_of_medicine": "Feraheme", "ema_product_number": "EMEA/H/C/005974", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ferumoxytol", "active_substance": "Ferumoxytol", "therapeutic_area_mesh": "Anemia, Iron-Deficiency", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03AC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Intravenous treatment of iron deficiency anaemia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Covis Pharma Europe B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "09/03/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/03/2023", "last_updated_date": "11/07/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/feraheme" }, { "category": "Human", "name_of_medicine": "Lenalidomide Krka d.d.", "ema_product_number": "EMEA/H/C/005729", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0003", "international_non_proprietary_name_common_name": "lenalidomide", "active_substance": "lenalidomide hydrochloride hydrate", "therapeutic_area_mesh": "Multiple Myeloma;Lymphoma, Follicular;Myelodysplastic Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Multiple myeloma Lenalidomide Krka d.d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Krka d.d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Krka d.d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromes Lenalidomide Krka d.d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Follicular lymphoma Lenalidomide Krka d.d. in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto ", "european_commission_decision_date": "13/12/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "18/02/2021", "last_updated_date": "10/07/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-krka-dd" }, { "category": "Human", "name_of_medicine": "Asimtufii", "ema_product_number": "EMEA/H/C/005929", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "aripiprazole", "active_substance": "aripiprazole monohydrate", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "aripiprazole", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Maintenance treatment of schizophrenia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Otsuka Pharmaceutical Netherlands B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "02/05/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/05/2023", "last_updated_date": "07/07/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/asimtufii" }, { "category": "Veterinary", "name_of_medicine": "Aftovaxpur DOE", "ema_product_number": "EMEA/V/C/002292", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1204/G", "international_non_proprietary_name_common_name": "inactivated vaccine against foot-and-mouth disease", "active_substance": "Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063.", "therapeutic_area_mesh": "", "species_veterinary": "Pigs;Cattle;Sheep", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI02AA04", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "Active immunisation of cattle, sheep and pigs from 2 weeks of age against foot-and-mouth disease to reduce clinical signs.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim Vetmedica GmbH", "european_commission_decision_date": "20/03/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/07/2013", "refusal_of_marketing_authorisation_date": "16/05/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "14/06/2018", "last_updated_date": "04/07/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/aftovaxpur-doe" }, { "category": "Human", "name_of_medicine": "Luminity", "ema_product_number": "EMEA/H/C/000654", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "0042/G", "international_non_proprietary_name_common_name": "perflutren", "active_substance": "perflutren", "therapeutic_area_mesh": "Echocardiography", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V08DA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Contrast media", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lantheus EU Limited", "european_commission_decision_date": "01/06/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/07/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "04/05/2018", "last_updated_date": "28/06/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/luminity" }, { "category": "Veterinary", "name_of_medicine": "Comfortis", "ema_product_number": "EMEA/V/C/002233", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0025/G", "international_non_proprietary_name_common_name": "spinosad", "active_substance": "spinosad", "therapeutic_area_mesh": "", "species_veterinary": "Dogs;Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QP53BX03", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Other ectoparasiticides for systemic use", "therapeutic_indication": "Treatment and prevention of flea infestations (Ctenocephalides felis). The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product. The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Elanco GmbH", "european_commission_decision_date": "10/09/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "08/12/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/02/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "07/01/2016", "last_updated_date": "26/06/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/comfortis" }, { "category": "Human", "name_of_medicine": "Tidhesco", "ema_product_number": "EMEA/H/C/006174", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ivosidenib", "active_substance": "Ivosidenib", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX62", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of newly diagnosed acute myeloid leukaemia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "27/03/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/05/2023", "last_updated_date": "21/06/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tidhesco" }, { "category": "Human", "name_of_medicine": "Nitisinone MDK (previously Nitisinone MendeliKABS)", "ema_product_number": "EMEA/H/C/004281", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0013", "international_non_proprietary_name_common_name": "nitisinone", "active_substance": "nitisinone", "therapeutic_area_mesh": "Tyrosinemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "MendeliKABS Europe Ltd", "european_commission_decision_date": "15/07/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/06/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/08/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "21/04/2018", "last_updated_date": "14/06/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nitisinone-mdk" }, { "category": "Human", "name_of_medicine": "Omblastys", "ema_product_number": "EMEA/H/C/005499", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "iodine (131I) omburtamab", "active_substance": "iodine (131I) omburtamab", "therapeutic_area_mesh": "Neuroblastoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V10XA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Therapeutic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neuroblastoma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Y-Mabs Therapeutics A/S", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "12/04/2023", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "04/11/2022", "last_updated_date": "14/06/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/omblastys" }, { "category": "Human", "name_of_medicine": "Nityr", "ema_product_number": "EMEA/H/C/004582", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0015", "international_non_proprietary_name_common_name": "nitisinone", "active_substance": "nitisinone", "therapeutic_area_mesh": "Tyrosinemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cycle Pharmaceuticals (Europe) Ltd", "european_commission_decision_date": "04/05/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/05/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "26/07/2018", "last_updated_date": "05/06/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nityr" }, { "category": "Human", "name_of_medicine": "Desloratadine Actavis", "ema_product_number": "EMEA/H/C/002435", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1612", "international_non_proprietary_name_common_name": "desloratadine", "active_substance": "desloratadine", "therapeutic_area_mesh": "Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R06AX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihistamines for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of allergic rhinitis and urticaria.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "31/05/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/01/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "21/03/2018", "last_updated_date": "01/06/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/desloratadine-actavis" }, { "category": "Human", "name_of_medicine": "Pioglitazone Actavis", "ema_product_number": "EMEA/H/C/002324", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1612", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as monotherapy in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. as dual oral therapy in combination with metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin. a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. as triple oral therapy in combination with metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4). After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "31/05/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/01/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/03/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "20/03/2018", "last_updated_date": "01/06/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pioglitazone-actavis" }, { "category": "Human", "name_of_medicine": "Pantozol Control", "ema_product_number": "EMEA/H/C/001013", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2321", "international_non_proprietary_name_common_name": "pantoprazole", "active_substance": "pantoprazole", "therapeutic_area_mesh": "Gastroesophageal Reflux", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A02BC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Proton pump inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda GmbH", "european_commission_decision_date": "26/04/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/02/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/06/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "02/07/2017", "last_updated_date": "25/05/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pantozol-control" }, { "category": "Human", "name_of_medicine": "Controloc Control", "ema_product_number": "EMEA/H/C/001097", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/2321", "international_non_proprietary_name_common_name": "pantoprazole", "active_substance": "pantoprazole", "therapeutic_area_mesh": "Gastroesophageal Reflux", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A02BC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Proton pump inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda GmbH", "european_commission_decision_date": "26/04/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/06/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "02/07/2018", "last_updated_date": "25/05/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/controloc-control" }, { "category": "Human", "name_of_medicine": "Somac Control", "ema_product_number": "EMEA/H/C/001098", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2321", "international_non_proprietary_name_common_name": "pantoprazole", "active_substance": "pantoprazole", "therapeutic_area_mesh": "Gastroesophageal Reflux", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A02BC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Proton pump inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda GmbH", "european_commission_decision_date": "26/04/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/02/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/06/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "02/07/2018", "last_updated_date": "24/05/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/somac-control" }, { "category": "Human", "name_of_medicine": "Fendrix", "ema_product_number": "EMEA/H/C/000550", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2365", "international_non_proprietary_name_common_name": "hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)", "active_substance": "hepatitis B surface antigen", "therapeutic_area_mesh": "Hepatitis B;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "26/04/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/02/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "27/10/2017", "last_updated_date": "24/05/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fendrix" }, { "category": "Human", "name_of_medicine": "Xenical", "ema_product_number": "EMEA/H/C/000154", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0088", "international_non_proprietary_name_common_name": "orlistat", "active_substance": "orlistat", "therapeutic_area_mesh": "Obesity", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A08AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiobesity preparations, excl. diet products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m2, or overweight patients (BMI > 28 kg/m2) with associated risk factors. Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CHEPLAPHARM Arzneimittel GmbH", "european_commission_decision_date": "10/05/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/07/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "02/05/2017", "last_updated_date": "10/05/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xenical" }, { "category": "Human", "name_of_medicine": "Pioglitazone Teva", "ema_product_number": "EMEA/H/C/002297", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0025", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Alimentary tract and metabolism", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pioglitazone is indicated in the treatment of type 2 diabetes mellitus: as monotherapy- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea as triple oral therapy in combination with- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "04/11/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/01/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "11/12/2017", "last_updated_date": "04/05/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pioglitazone-teva" }, { "category": "Human", "name_of_medicine": "NeuroBloc", "ema_product_number": "EMEA/H/C/000301", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0107", "international_non_proprietary_name_common_name": "botulinum toxin type B", "active_substance": "botulinum toxin type B", "therapeutic_area_mesh": "Torticollis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M03AX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Muscle relaxants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "NeuroBloc is indicated for the treatment of cervical dystonia (torticollis). See section 5.1 for data on efficacy in patients responsive / resistant to botulinum toxin type A.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sloan Pharma S.a.r.l", "european_commission_decision_date": "04/03/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/10/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/01/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "23/04/2018", "last_updated_date": "04/05/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neurobloc" }, { "category": "Human", "name_of_medicine": "Stocrin", "ema_product_number": "EMEA/H/C/000250", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/130", "international_non_proprietary_name_common_name": "efavirenz", "active_substance": "efavirenz", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Stocrin has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Stocrin.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "14/04/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/1999", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/05/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "49", "first_published_date": "30/07/2018", "last_updated_date": "25/04/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/stocrin" }, { "category": "Human", "name_of_medicine": "Raltegravir Viatris", "ema_product_number": "EMEA/H/C/005813", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "raltegravir potassium", "active_substance": "raltegravir potassium", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AJ01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of human immunodeficiency virus (HIV-1)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viatris Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "22/02/2023", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/03/2023", "last_updated_date": "21/04/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/raltegravir-viatris" }, { "category": "Human", "name_of_medicine": "Lamivudine Teva Pharma B.V.", "ema_product_number": "EMEA/H/C/001111", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0030", "international_non_proprietary_name_common_name": "lamivudine", "active_substance": "lamivudine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V. ", "european_commission_decision_date": "21/04/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/12/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "20/04/2018", "last_updated_date": "21/04/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lamivudine-teva-pharma-bv" }, { "category": "Human", "name_of_medicine": "Inpremzia", "ema_product_number": "EMEA/H/C/005331", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "insulin human (rDNA)", "active_substance": "insulin human (rDNA)", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Inpremzia is indicated for the treatment of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Baxter Holding B.V.", "european_commission_decision_date": "04/04/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/02/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/04/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/02/2022", "last_updated_date": "20/04/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/inpremzia" }, { "category": "Human", "name_of_medicine": "Ceplene", "ema_product_number": "EMEA/H/C/000796", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0043", "international_non_proprietary_name_common_name": "histamine dihydrochloride", "active_substance": "histamine dihydrochloride", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2). The efficacy of Ceplene has not been fully demonstrated in patients older than age 60.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoires Delbert", "european_commission_decision_date": "09/09/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/10/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "26/07/2018", "last_updated_date": "19/04/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ceplene" }, { "category": "Human", "name_of_medicine": "Emtriva", "ema_product_number": "EMEA/H/C/000533", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0141", "international_non_proprietary_name_common_name": "emtricitabine", "active_substance": "emtricitabine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents. This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens. When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "18/04/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/10/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "24/07/2018", "last_updated_date": "18/04/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emtriva" }, { "category": "Human", "name_of_medicine": "Granpidam", "ema_product_number": "EMEA/H/C/004289", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0015", "international_non_proprietary_name_common_name": "sildenafil", "active_substance": "sildenafil citrate", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "30/03/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "17/01/2017", "last_updated_date": "11/04/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/granpidam" }, { "category": "Human", "name_of_medicine": "DepoCyte", "ema_product_number": "EMEA/H/C/000317", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0059", "international_non_proprietary_name_common_name": "cytarabine", "active_substance": "cytarabine", "therapeutic_area_mesh": "Meningeal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pacira Limited", "european_commission_decision_date": "26/06/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/07/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "26/06/2017", "last_updated_date": "03/04/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/depocyte" }, { "category": "Human", "name_of_medicine": "Dasatinib Accord", "ema_product_number": "EMEA/H/C/005446", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0001", "international_non_proprietary_name_common_name": "dasatinib (anhydrous)", "active_substance": "dasatinib", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma;Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dasatinib Accord is indicated for the treatment of adult patients with: • Ph+ acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy. Dasatinib Accord is indicated for the treatment of paediatric patients with: • newly diagnosed Ph+ ALL in combination with chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "08/06/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/01/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/03/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "24/01/2022", "last_updated_date": "30/03/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dasatinib-accord" }, { "category": "Human", "name_of_medicine": "Dasatinib Accordpharma", "ema_product_number": "EMEA/H/C/005317", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0001", "international_non_proprietary_name_common_name": "dasatinib (anhydrous)", "active_substance": "dasatinib", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma;Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dasatinib Accordpharma is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Dasatinib Accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ ALL in combination with chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "22/06/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/01/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/03/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "24/01/2022", "last_updated_date": "30/03/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dasatinib-accordpharma" }, { "category": "Veterinary", "name_of_medicine": "Newflend ND H9", "ema_product_number": "EMEA/V/C/005860", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "turkey herpes virus, strain rHVT/ND expressing Newcastle disease virus, live", "active_substance": "turkey herpes virus, strain rHVT/ND expressing Newcastle disease virus, live", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves;Live viral vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/03/2023", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/newflend-nd-h9" }, { "category": "Human", "name_of_medicine": "Lamivudine/Zidovudine Teva", "ema_product_number": "EMEA/H/C/001236", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0028", "international_non_proprietary_name_common_name": "lamivudine;zidovudine", "active_substance": "lamivudine;zidovudine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V. ", "european_commission_decision_date": "21/03/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/11/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/02/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "20/04/2018", "last_updated_date": "21/03/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lamivudine-zidovudine-teva" }, { "category": "Human", "name_of_medicine": "Vihuma", "ema_product_number": "EMEA/H/C/004459", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS2244", "international_non_proprietary_name_common_name": "simoctocog alfa", "active_substance": "simoctocog alfa", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Vihuma can be used for all age groups.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Octapharma AB", "european_commission_decision_date": "13/10/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/02/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "13/02/2017", "last_updated_date": "21/03/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vihuma" }, { "category": "Human", "name_of_medicine": "Nevirapine Teva", "ema_product_number": "EMEA/H/C/001119", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0024", "international_non_proprietary_name_common_name": "nevirapine", "active_substance": "nevirapine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AG01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nevirapine Teva is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV 1 infected adults, adolescents, and children of any age. Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V. ", "european_commission_decision_date": "08/12/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/11/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "28/08/2016", "last_updated_date": "21/03/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nevirapine-teva" }, { "category": "Human", "name_of_medicine": "Pregabalin Zentiva k.s.", "ema_product_number": "EMEA/H/C/004277", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0022/G", "international_non_proprietary_name_common_name": "pregabalin", "active_substance": "pregabalin", "therapeutic_area_mesh": "Anxiety Disorders;Neuralgia;Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Neuropathic pain Pregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorder Pregabalin Zentiva k.s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva k.s.", "european_commission_decision_date": "23/02/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/02/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "18/05/2018", "last_updated_date": "20/03/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pregabalin-zentiva-ks" }, { "category": "Human", "name_of_medicine": "Temozolomide Sandoz", "ema_product_number": "EMEA/H/C/001128", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0036", "international_non_proprietary_name_common_name": "temozolomide", "active_substance": "temozolomide", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "15/09/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/09/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/03/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/09/2022", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "06/07/2018", "last_updated_date": "06/03/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/temozolomide-sandoz" }, { "category": "Human", "name_of_medicine": "Hepsera", "ema_product_number": "EMEA/H/C/000485", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0086", "international_non_proprietary_name_common_name": "adefovir dipivoxil", "active_substance": "adefovir dipivoxil", "therapeutic_area_mesh": "Hepatitis B, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Nucleoside and nucleotide reverse transcriptase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hepsera is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum-alanine-aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1); decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "20/04/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/11/2002", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/03/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "31/12/2022", "suspension_of_marketing_authorisation_date": "", "revision_number": "27", "first_published_date": "24/07/2018", "last_updated_date": "06/03/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hepsera" }, { "category": "Human", "name_of_medicine": "Efavirenz Teva", "ema_product_number": "EMEA/H/C/002352", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0027/G", "international_non_proprietary_name_common_name": "efavirenz", "active_substance": "efavirenz", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children 3 years of age and older. Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with protease inhibitors (PIs) has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "27/02/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "09/09/2016", "last_updated_date": "03/03/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/efavirenz-teva" }, { "category": "Human", "name_of_medicine": "Kogenate Bayer", "ema_product_number": "EMEA/H/C/000275", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "A31/0185", "international_non_proprietary_name_common_name": "octocog alfa", "active_substance": "octocog alfa", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG ", "european_commission_decision_date": "16/11/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/08/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "31/12/2022", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "16/11/2017", "last_updated_date": "02/03/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kogenate-bayer" }, { "category": "Human", "name_of_medicine": "Garsun", "ema_product_number": "EMEA/H/C/005718", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "artesunate", "active_substance": "artesunate", "therapeutic_area_mesh": "Malaria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "P01BE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiprotozoals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of severe malaria", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "B And O Pharm", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "08/12/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/03/2023", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/garsun" }, { "category": "Human", "name_of_medicine": "Temozolomide Hexal", "ema_product_number": "EMEA/H/C/001127", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0037", "international_non_proprietary_name_common_name": "temozolomide", "active_substance": "temozolomide", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Hexal AG", "european_commission_decision_date": "15/09/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/03/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "19/06/2018", "last_updated_date": "27/02/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/temozolomide-hexal" }, { "category": "Human", "name_of_medicine": "NovoSeven", "ema_product_number": "EMEA/H/C/000074", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0119", "international_non_proprietary_name_common_name": "eptacog alfa (activated)", "active_substance": "eptacog alfa (activated)", "therapeutic_area_mesh": "Hemophilia B;Thrombasthenia;Factor VII Deficiency;Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 Bethesda units (BU); in patients with congenital haemophilia who are expected to have a high anamnestic response to factor-VIII or factor-IX administration; in patients with acquired haemophilia; in patients with congenital factor-VII deficiency; in patients with Glanzmann's thrombasthenia with antibodies to platelet glycoprotein (GP) IIb-IIIa and / or human leucocyte antigens (HLA), and with past or present refractoriness to platelet transfusions. in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "23/02/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/02/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "38", "first_published_date": "08/12/2016", "last_updated_date": "27/02/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/novoseven" }, { "category": "Human", "name_of_medicine": "Aloxi", "ema_product_number": "EMEA/H/C/000563", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0045/G", "international_non_proprietary_name_common_name": "palonosetron", "active_substance": "palonosetron hydrochloride", "therapeutic_area_mesh": "Vomiting;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A04AA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiemetics and antinauseants;Serotonin (5HT3) antagonists", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aloxi is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Aloxi is indicated in paediatric patients 1 month of age and older for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Helsinn Birex Pharmaceuticals Ltd.", "european_commission_decision_date": "26/04/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/03/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "26/04/2018", "last_updated_date": "24/02/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aloxi" }, { "category": "Human", "name_of_medicine": "Vizarsin", "ema_product_number": "EMEA/H/C/001076", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0036", "international_non_proprietary_name_common_name": "sildenafil", "active_substance": "sildenafil", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Vizarsin to be effective, sexual stimulation is required.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "22/02/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "06/12/2017", "last_updated_date": "24/02/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vizarsin" }, { "category": "Human", "name_of_medicine": "Odefsey", "ema_product_number": "EMEA/H/C/004156", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1588", "international_non_proprietary_name_common_name": "emtricitabine;rilpivirine;tenofovir alafenamide", "active_substance": "emtricitabine;rilpivirine hydrochloride;tenofovir alafenamide", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR19", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (HIV 1) without known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ? 100,000 HIV 1 RNA copies/mL.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "16/02/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/04/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/06/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "16/05/2018", "last_updated_date": "20/02/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/odefsey" }, { "category": "Human", "name_of_medicine": "Xagrid", "ema_product_number": "EMEA/H/C/000480", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0100/G", "international_non_proprietary_name_common_name": "anagrelide", "active_substance": "anagrelide", "therapeutic_area_mesh": "Thrombocythemia, Essential", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX35", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xagrid is indicated for the reduction of elevated platelet counts in at-risk essential-thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy. An at-risk patient An at-risk ET is defined by one or more of the following features: >60 years of age or; a platelet count >1000 x 109/l or; a history of thrombohaemorrhagic events.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG Ireland", "european_commission_decision_date": "16/02/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "40", "first_published_date": "11/07/2018", "last_updated_date": "20/02/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xagrid" }, { "category": "Human", "name_of_medicine": "Tybost", "ema_product_number": "EMEA/H/C/002572", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0064", "international_non_proprietary_name_common_name": "cobicistat", "active_substance": "cobicistat", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults and adolescents aged 12 years and older: weighing at least 35 kg co?administered with atazanavir or weighing at least 40 kg co?administered with darunavir.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "13/02/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "26/07/2018", "last_updated_date": "14/02/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tybost" }, { "category": "Human", "name_of_medicine": "Aliqopa", "ema_product_number": "EMEA/H/C/004334", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "copanlisib", "active_substance": "copanlisib dihydrochloride", "therapeutic_area_mesh": "Lymphoma, B-Cell, Marginal Zone", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with relapsed marginal zone lymphoma", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/12/2021", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/01/2022", "last_updated_date": "10/02/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aliqopa" }, { "category": "Human", "name_of_medicine": "Hemangiol", "ema_product_number": "EMEA/H/C/002621", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0023", "international_non_proprietary_name_common_name": "propranolol", "active_substance": "propranolol hydrochloride", "therapeutic_area_mesh": "Hemangioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C07AA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Beta blocking agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hemangiol is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy: Life- or function-threatening haemangioma, Ulcerated haemangioma with pain and/or lack of response to simple wound care measures, Haemangioma with a risk of permanent scars or disfigurement. It is to be initiated in infants aged 5 weeks to 5 months.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pierre Fabre Medicament", "european_commission_decision_date": "10/01/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/02/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "14/03/2018", "last_updated_date": "09/02/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hemangiol" }, { "category": "Human", "name_of_medicine": "Miplyffa", "ema_product_number": "EMEA/H/C/005203", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "arimoclomol", "active_substance": "arimoclomol citrate", "therapeutic_area_mesh": "Niemann-Pick Disease, Type C", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Niemann-Pick disease type C (NPC).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Orphazyme A/S", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "22/03/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/04/2022", "last_updated_date": "08/02/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/miplyffa" }, { "category": "Human", "name_of_medicine": "Imbarkyd", "ema_product_number": "EMEA/H/C/005869", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bardoxolone methyl", "active_substance": "Bardoxolone methyl", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of chronic kidney disease", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Reata Ireland Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "09/11/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/12/2022", "last_updated_date": "07/02/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imbarkyd" }, { "category": "Human", "name_of_medicine": "Darunavir Krka d.d.", "ema_product_number": "EMEA/H/C/004891", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0011", "international_non_proprietary_name_common_name": "darunavir", "active_substance": "darunavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "400mg and 800 mg Film-coated Tablets Darunavir Krka d.d., co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir Krka d.d., co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection in adult patients (see section 4.2). Darunavir Krka d.d. 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART)-naïve (see section 4.2). ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ? 100 cells x 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1). 600mg Film-coated Tablets Darunavir Krka d.d., co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir Krka d.d. 600 mg tablets may be used to provide suitable dose regimens (see section 4.2): For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated. For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "KRKA, d.d., Novo mesto", "european_commission_decision_date": "22/01/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/01/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/01/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "13/06/2018", "last_updated_date": "03/02/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/darunavir-krka-dd" }, { "category": "Human", "name_of_medicine": "Febseltiq", "ema_product_number": "EMEA/H/C/005361", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "infigratinib", "active_substance": "Infigratinib monophosphate", "therapeutic_area_mesh": "Cholangiocarcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01E", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of cholangiocarcinoma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Helsinn Birex Pharmaceuticals Ltd", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "11/10/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/11/2022", "last_updated_date": "30/01/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/febseltiq" }, { "category": "Veterinary", "name_of_medicine": "Versiguard SARS CoV2", "ema_product_number": "EMEA/V/C/005988", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "recombinant SARS CoV2 spike protein", "active_substance": "recombinant SARS CoV2 spike protein", "therapeutic_area_mesh": "", "species_veterinary": "Mink", "patient_safety": "No", "atc_code_human": "QI20CX", "atcvet_code_veterinary": "QI20CX", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for other species", "therapeutic_indication": "Active immunisation of mink from 6 weeks of age to reduce infection and virus shedding following infection with SARS CoV2.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zoetis Belgium", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "15/09/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/01/2023", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/versiguard-sars-cov2" }, { "category": "Human", "name_of_medicine": "Pemetrexed Baxter", "ema_product_number": "EMEA/H/C/005848", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed disodium heptahydrate", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Mesothelioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Malignant pleural mesotheliomaPemetrexed Baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancerPemetrexed Baxter in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1). Pemetrexed Baxter is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5.1). Pemetrexed Baxter is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Baxter Holding B.V.", "european_commission_decision_date": "09/12/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/10/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/10/2022", "last_updated_date": "19/01/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-baxter" }, { "category": "Human", "name_of_medicine": "Trogarzo", "ema_product_number": "EMEA/H/C/004961", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0020", "international_non_proprietary_name_common_name": "ibalizumab", "active_substance": "Ibalizumab", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of adults infected with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Theratechnologies Europe Limited", "european_commission_decision_date": "12/10/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/09/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/01/2023", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "10/10/2019", "last_updated_date": "16/01/2023", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trogarzo" }, { "category": "Human", "name_of_medicine": "Ammonaps", "ema_product_number": "EMEA/H/C/000219", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0063", "international_non_proprietary_name_common_name": "sodium phenylbutyrate", "active_substance": "sodium phenylbutyrate", "therapeutic_area_mesh": "Ornithine Carbamoyltransferase Deficiency Disease;Citrullinemia;Carbamoyl-Phosphate Synthase I Deficiency Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase. It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Immedica Pharma AB", "european_commission_decision_date": "12/12/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/12/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "28/06/2017", "last_updated_date": "16/12/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ammonaps" }, { "category": "Human", "name_of_medicine": "IntronA", "ema_product_number": "EMEA/H/C/000281", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0122", "international_non_proprietary_name_common_name": "interferon alfa-2b", "active_substance": "interferon alfa-2b", "therapeutic_area_mesh": "Carcinoid Tumor;Leukemia, Hairy Cell;Lymphoma, Follicular;Hepatitis B, Chronic;Hepatitis C, Chronic;Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Melanoma;Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Chronic hepatitis B Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis-B viral replication (presence of DNA of hepatitis-B virus (HBV-DNA) and hepatitis-B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and / or fibrosis. Chronic hepatitis C Before initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon. Adult patients IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for hepatitis-C virus-RNA (HCV-RNA). The best way to use IntronA in this indication is in combination with ribavirin. Children three years of age and older and adolescents IntronA is indicated, in a combination regimen with ribavirin, for the treatment of children three years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients. The decision to treat should be made on a case-by-case basis. Hairy-cell leukaemia Treatment of patients with hairy cell leukaemia. Chronic myelogenous leukaemia Monotherapy Treatment of adult patients with Philadelphia-chromosome- or bcr/abl-translocation-positive chronic myelogenous leukaemia. Clinical experience indicates that a haematological and cytogenetic major / minor response is obtainable in the majority of patients treated. A major cytogenetic response is defined by < 34 % Ph+ leukaemic cells in the bone marrow, whereas a minor response is ? 34 %, but < 90 % Ph+ cells in the marrow. Combination therapy The combination of interferon alfa-2b and cytarabine (Ara-C) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy. Multiple myeloma As maintenance therapy in patients who have achieved objective remission (more than 50% reduction in myeloma protein) following initial induction chemotherapy. Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated. Follicular lymphoma Treatment of high-tumour-burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen. High tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10 %, pyrexia > 38°C for more than eight days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia. Carcinoid tumour Treatment of carcinoid tumours with lymph node or liver metastases and with 'carcinoid syndrome'. Malignant melanoma As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g. patients with primary or recurrent (clinical or pathological) lymph-node.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "10/06/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/03/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "34", "first_published_date": "28/09/2017", "last_updated_date": "15/12/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/introna" }, { "category": "Human", "name_of_medicine": "Hervelous", "ema_product_number": "EMEA/H/C/005880", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "trastuzumab", "active_substance": "trastuzumab", "therapeutic_area_mesh": "Stomach Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Prestige Biopharma Belgium", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "14/09/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/10/2022", "last_updated_date": "13/12/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hervelous" }, { "category": "Human", "name_of_medicine": "Tuznue", "ema_product_number": "EMEA/H/C/005066", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "trastuzumab", "active_substance": "trastuzumab", "therapeutic_area_mesh": "Stomach Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Prestige Biopharma Belgium", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "14/09/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/10/2022", "last_updated_date": "13/12/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tuznue-0" }, { "category": "Human", "name_of_medicine": "Tookad", "ema_product_number": "EMEA/H/C/004182", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0020", "international_non_proprietary_name_common_name": "padeliporfin", "active_substance": "padeliporfin di-potassium", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life expectancy ? 10 years and: Clinical stage T1c or T2a; Gleason Score ? 6, based on high-resolution biopsy strategies; PSA ? 10 ng/mL; 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ? 50 % cancer involvement in any one core or a PSA density ? 0.15 ng/mL/cm³.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "STEBA Biotech S.A", "european_commission_decision_date": "07/12/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "21/09/2017", "last_updated_date": "07/12/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tookad" }, { "category": "Human", "name_of_medicine": "Macugen", "ema_product_number": "EMEA/H/C/000620", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0065", "international_non_proprietary_name_common_name": "pegaptanib", "active_substance": "pegaptanib", "therapeutic_area_mesh": "Wet Macular Degeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "PharmaSwiss Ceska Republika s.r.o", "european_commission_decision_date": "20/07/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/01/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "20/07/2016", "last_updated_date": "02/12/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/macugen" }, { "category": "Human", "name_of_medicine": "Zynteglo", "ema_product_number": "EMEA/H/C/003691", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0030", "international_non_proprietary_name_common_name": "betibeglogene autotemcel", "active_substance": "autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene", "therapeutic_area_mesh": "beta-Thalassemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06A", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zynteglo is indicated for the treatment of patients 12 years and older with transfusion-dependent β thalassaemia (TDT) who do not have a β0/β0 genotype, for whom haematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available.  ", "accelerated_assessment": "Yes", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "bluebird bio (Netherlands) B.V.", "european_commission_decision_date": "09/12/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/03/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/05/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "24/03/2022", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "03/06/2019", "last_updated_date": "30/11/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zynteglo" }, { "category": "Human", "name_of_medicine": "Cevenfacta", "ema_product_number": "EMEA/H/C/005655", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "eptacog beta (activated)", "active_substance": "Eptacog beta (activated)", "therapeutic_area_mesh": "Hemophilia A;Hemophilia B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: in patients with congenital haemophilia with high-responding inhibitors to coagulation factors VIII or IX (i.e. ?5 Bethesda Units (BU));  in patients with congenital haemophilia with low titre inhibitors (BU <5), but expected to have a high anamnestic response to factor VIII or factor IX administration or expected to be refractory to increased dosing of FVIII or FIX.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoire Francais du Fractionnement et des Biotechnologies", "european_commission_decision_date": "19/05/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/07/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/05/2022", "last_updated_date": "29/11/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cevenfacta" }, { "category": "Human", "name_of_medicine": "Temybric Ellipta", "ema_product_number": "EMEA/H/C/005254", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/2130/G", "international_non_proprietary_name_common_name": "fluticasone furoate;umeclidinium;vilanterol", "active_substance": "fluticasone furoate;umeclidinium bromide;vilanterol trifenatate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AL08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Temybric Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting ?2-agonist or a combination of a long-acting ?2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "11/12/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/06/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "14/06/2022", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "23/09/2019", "last_updated_date": "24/11/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/temybric-ellipta" }, { "category": "Human", "name_of_medicine": "Exkivity", "ema_product_number": "EMEA/H/C/005621", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "mobocertinib", "active_substance": "mobocertinib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/07/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/08/2022", "last_updated_date": "24/11/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exkivity" }, { "category": "Human", "name_of_medicine": "Abylqis", "ema_product_number": "EMEA/H/C/004810", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "arachis hypogaea extract", "active_substance": "arachis hypogaea extract", "therapeutic_area_mesh": "Peanut Hypersensitivity", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V01AA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Allergens", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of peanut allergy", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "DBV Technologies", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/12/2021", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/01/2022", "last_updated_date": "23/11/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abylqis" }, { "category": "Human", "name_of_medicine": "Sevsury", "ema_product_number": "EMEA/H/C/005728", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "surufatinib", "active_substance": "surufatinib", "therapeutic_area_mesh": "Neuroendocrine Tumors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of progressive neuroendocrine tumours", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Hutchmed Europe B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "01/08/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/08/2022", "last_updated_date": "16/11/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sevsury" }, { "category": "Veterinary", "name_of_medicine": "Neoleish", "ema_product_number": "EMEA/V/C/005538", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bacterial DNA plasmid containing LACK gene from Leishmania infantum", "active_substance": "bacterial DNA plasmid containing LACK gene from Leishmania infantum", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for canidae;Other immunologicals", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/11/2022", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/neoleish" }, { "category": "Human", "name_of_medicine": "Orepaxam", "ema_product_number": "EMEA/H/C/005990", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "treprostinil diolamine", "active_substance": "treprostinil diolamine", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominantly patients with WHO functional class II-III symptoms and aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease (see section 5.1). Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ferrer Internacional S.A.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "11/10/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/11/2022", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orepaxam" }, { "category": "Human", "name_of_medicine": "Parsaclisib Incyte Biosciences Distribution B.V.", "ema_product_number": "EMEA/H/C/005893", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "parsaclisib", "active_substance": "Parsaclisib hydrochloride", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EM04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of marginal zone lymphoma", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Incyte Biosciences Distribution B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "27/06/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/07/2022", "last_updated_date": "08/11/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/parsaclisib-incyte-biosciences-distribution-bv" }, { "category": "Human", "name_of_medicine": "Dimherity", "ema_product_number": "EMEA/H/C/006042", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dimethyl fumarate", "active_substance": "dimethyl fumarate", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of multiple sclerosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "24/03/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "22/02/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/03/2022", "last_updated_date": "03/11/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dimherity" }, { "category": "Human", "name_of_medicine": "Glubrava", "ema_product_number": "EMEA/H/C/000893", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1979/G", "international_non_proprietary_name_common_name": "pioglitazone;metformin", "active_substance": "metformin hydrochloride;pioglitazone hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Glubrava is indicated as second line treatment of type-2-diabetes-mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "04/02/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/12/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "10/11/2017", "last_updated_date": "18/10/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/glubrava" }, { "category": "Human", "name_of_medicine": "Glidipion (previously Pioglitazone Actavis Group)", "ema_product_number": "EMEA/H/C/002558", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1791", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below: as monotherapy: in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with: metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "11/06/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/03/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "28/07/2017", "last_updated_date": "17/10/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/glidipion" }, { "category": "Human", "name_of_medicine": "Glustin", "ema_product_number": "EMEA/H/C/000286", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1979/G", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below: as monotherapy: in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. as dual oral therapy in combination with: metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "04/02/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/10/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "26/05/2016", "last_updated_date": "17/10/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/glustin" }, { "category": "Veterinary", "name_of_medicine": "Activyl Tick Plus", "ema_product_number": "EMEA/V/C/002234", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0016", "international_non_proprietary_name_common_name": "indoxacarb;permethrin", "active_substance": "indoxacarb;permethrin", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QP53AC54", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "permethrin, combinations;Ectoparasiticides for topical use, incl. insecticides", "therapeutic_indication": "Treatment of flea infestations (Ctenocephalides felis); the product has persistent insecticidal efficacy for up to 4 weeks against Ctenocephalides felis. The product has persistent acaricidal efficacy for up to 5 weeks against Ixodes ricinus and up to 3 weeks against Rhipicephalus sanguineus. One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus perniciosus) for up to 3 weeks.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "29/09/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "15/03/2018", "last_updated_date": "04/10/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/activyl-tick-plus" }, { "category": "Human", "name_of_medicine": "Firmagon", "ema_product_number": "EMEA/H/C/000986", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0041", "international_non_proprietary_name_common_name": "degarelix", "active_substance": "degarelix", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L02BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Endocrine therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated: - for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ferring Pharmaceuticals A/S", "european_commission_decision_date": "30/03/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/02/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "25/07/2018", "last_updated_date": "04/10/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/firmagon" }, { "category": "Veterinary", "name_of_medicine": "Nobilis OR Inac", "ema_product_number": "EMEA/V/C/000062", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0005", "international_non_proprietary_name_common_name": "adjuvanted inactivated vaccine against Ornithobacterium rhinotracheale serotype A", "active_substance": "inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A, strain B3263/91", "therapeutic_area_mesh": "", "species_veterinary": "Chicken", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI01AB07", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves", "therapeutic_indication": "For passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved. Under field conditions passive immunity is transferred during lay for 43 weeks after the last vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14 days after hatching.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "29/08/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/01/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "10/01/2008", "last_updated_date": "03/10/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-or-inac" }, { "category": "Human", "name_of_medicine": "HemAryo", "ema_product_number": "EMEA/H/C/005547", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "eptacog alfa (activated)", "active_substance": "eptacog alfa (activated)", "therapeutic_area_mesh": "Hemophilia A;Hemophilia B;Factor VII Deficiency", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of bleeding episodes and for the prevention of bleeding.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UGA Biopharma", "european_commission_decision_date": "19/05/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "06/05/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/05/2022", "last_updated_date": "27/09/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hemaryo" }, { "category": "Human", "name_of_medicine": "Zalviso", "ema_product_number": "EMEA/H/C/002784", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0017", "international_non_proprietary_name_common_name": "sufentanil", "active_substance": "sufentanil", "therapeutic_area_mesh": "Pain, Postoperative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N01AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anesthetics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "FGK Representative Service GmbH", "european_commission_decision_date": "05/08/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "22/05/2017", "last_updated_date": "27/09/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zalviso" }, { "category": "Human", "name_of_medicine": "Incresync", "ema_product_number": "EMEA/H/C/002178", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0043", "international_non_proprietary_name_common_name": "alogliptin;pioglitazone", "active_substance": "alogliptin;pioglitazone", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Combinations of oral blood glucose lowering drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance; in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type-2 diabetes mellitus already being treated with this combination. After initiation of therapy with Incresync, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, Incresync should be discontinued. In light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync is maintained (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "07/09/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "25/05/2018", "last_updated_date": "09/09/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/incresync" }, { "category": "Human", "name_of_medicine": "Pioglitazone Teva Pharma", "ema_product_number": "EMEA/H/C/002410", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0024", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pioglitazone is indicated in the treatment of type-2 diabetes mellitus as monotherapy: in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "21/06/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/01/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/06/2021", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "31/01/2018", "last_updated_date": "30/08/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pioglitazone-teva-pharma" }, { "category": "Human", "name_of_medicine": "Epivir", "ema_product_number": "EMEA/H/C/000107", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG1532", "international_non_proprietary_name_common_name": "lamivudine", "active_substance": "lamivudine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare BV", "european_commission_decision_date": "11/08/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/08/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "50", "first_published_date": "05/03/2018", "last_updated_date": "29/08/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/epivir" }, { "category": "Human", "name_of_medicine": "Combivir", "ema_product_number": "EMEA/H/C/000190", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG1532", "international_non_proprietary_name_common_name": "lamivudine;zidovudine", "active_substance": "lamivudine;zidovudine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ViiV Healthcare BV", "european_commission_decision_date": "11/08/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/1997", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/03/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "37", "first_published_date": "25/01/2018", "last_updated_date": "29/08/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/combivir" }, { "category": "Human", "name_of_medicine": "Zynquista", "ema_product_number": "EMEA/H/C/004889", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0005", "international_non_proprietary_name_common_name": "sotagliflozin", "active_substance": "sotagliflozin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 1", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ? 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Guidehouse Germany GmbH", "european_commission_decision_date": "22/03/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/02/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/04/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/03/2022", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "27/02/2019", "last_updated_date": "16/08/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zynquista" }, { "category": "Human", "name_of_medicine": "Thymanax", "ema_product_number": "EMEA/H/C/000916", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0048", "international_non_proprietary_name_common_name": "agomelatine", "active_substance": "agomelatine", "therapeutic_area_mesh": "Depressive Disorder, Major", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of major depressive episodes in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Servier (Ireland) Industries Ltd", "european_commission_decision_date": "31/07/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/07/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/02/2009", "refusal_of_marketing_authorisation_date": "18/11/2006", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "31/07/2022", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "11/09/2017", "last_updated_date": "08/08/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/thymanax" }, { "category": "Human", "name_of_medicine": "Aduhelm", "ema_product_number": "EMEA/H/C/005558", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "aducanumab", "active_substance": "aducanumab", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biogen Netherlands B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/04/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/04/2022", "last_updated_date": "01/08/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aduhelm" }, { "category": "Veterinary", "name_of_medicine": "Bovilis BTV8", "ema_product_number": "EMEA/V/C/000148", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0007", "international_non_proprietary_name_common_name": "bluetongue virus serotype 8", "active_substance": "bluetongue virus vaccine, serotype 8 (inactivated)", "therapeutic_area_mesh": "", "species_veterinary": "Sheep;Cattle", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI04AA02", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Inactivated viral vaccines;bluetongue virus;SHEEP", "therapeutic_indication": "Cattle To stimulate active immunity in sheep from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia Sheep To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "05/06/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/09/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "05/06/2015", "last_updated_date": "27/07/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bovilis-btv8" }, { "category": "Human", "name_of_medicine": "Ganirelix Gedeon Richter", "ema_product_number": "EMEA/H/C/005641", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ganirelix", "active_substance": "ganirelix acetate", "therapeutic_area_mesh": "Reproductive Techniques, Assisted;Ovulation Induction;Infertility, Female", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01CC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)", "european_commission_decision_date": "15/07/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/05/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/07/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/05/2022", "last_updated_date": "20/07/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ganirelix-gedeon-richter" }, { "category": "Human", "name_of_medicine": "Episalvan", "ema_product_number": "EMEA/H/C/003938", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "birch bark extract", "active_substance": "Betulae cortex", "therapeutic_area_mesh": "Wounds and Injuries;Wound Healing", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D03AX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Preparations for treatment of wounds and ulcers", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of partial thickness wounds in adults. See sections 4.4 and 5.1 in Product Information with respect to type of wounds studied.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amryt AG", "european_commission_decision_date": "07/06/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/01/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "07/06/2022", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "30/05/2018", "last_updated_date": "15/07/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/episalvan" }, { "category": "Human", "name_of_medicine": "Elmiron", "ema_product_number": "EMEA/H/C/004246", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0027", "international_non_proprietary_name_common_name": "pentosan polysulfate sodium", "active_substance": "pentosan polysulfate sodium", "therapeutic_area_mesh": "Cystitis, Interstitial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BX15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "bene-Arzneimittel GmbH", "european_commission_decision_date": "15/07/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/06/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "14/08/2018", "last_updated_date": "15/07/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elmiron" }, { "category": "Human", "name_of_medicine": "Deferiprone Lipomed", "ema_product_number": "EMEA/H/C/004710", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0011", "international_non_proprietary_name_common_name": "deferiprone", "active_substance": "Deferiprone", "therapeutic_area_mesh": "Iron Overload;beta-Thalassemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Deferiprone Lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate. Deferiprone Lipomed in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload justifies rapid or intensive correction.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lipomed GmbH", "european_commission_decision_date": "26/06/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "27/07/2018", "last_updated_date": "14/07/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/deferiprone-lipomed" }, { "category": "Human", "name_of_medicine": "Crixivan", "ema_product_number": "EMEA/H/C/000128", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0104", "international_non_proprietary_name_common_name": "indinavir", "active_substance": "indinavir sulfate ethanolate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Crixivan is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "03/08/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/10/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "39", "first_published_date": "19/06/2018", "last_updated_date": "12/07/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/crixivan" }, { "category": "Human", "name_of_medicine": "Senstend", "ema_product_number": "EMEA/H/C/005298", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "lidocaine;prilocaine", "active_substance": "lidocaine;prilocaine", "therapeutic_area_mesh": "Premature Ejaculation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N01BB20", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anesthetics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Senstend is indicated for the treatment of primary premature ejaculation in adult men.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Plethora Pharma Solutions Limited", "european_commission_decision_date": "14/11/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/11/2019", "last_updated_date": "05/07/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/senstend" }, { "category": "Human", "name_of_medicine": "Imatinib Actavis", "ema_product_number": "EMEA/H/C/002594", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0020", "international_non_proprietary_name_common_name": "imatinib", "active_substance": "imatinib", "therapeutic_area_mesh": "Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Myelodysplastic-Myeloproliferative Diseases;Hypereosinophilic Syndrome;Dermatofibrosarcoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01EA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Protein kinase inhibitors;Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imatinib Actavis is indicated for the treatment of: paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment; paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis; adult patients with Ph+ CML in blast crisis; adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy; adult patients with relapsed or refractory Ph+ ALL as monotherapy; adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements; adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement; the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. The effect of imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib Actavis is indicated for: In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "16/12/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/02/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/04/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "08/01/2018", "last_updated_date": "05/07/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imatinib-actavis" }, { "category": "Human", "name_of_medicine": "Sildenafil Teva", "ema_product_number": "EMEA/H/C/001073", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0041", "international_non_proprietary_name_common_name": "sildenafil", "active_substance": "sildenafil", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in erectile dysfunction", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil Teva to be effective, sexual stimulation is required.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V. ", "european_commission_decision_date": "01/07/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/11/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "25/04/2016", "last_updated_date": "04/07/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sildenafil-teva" }, { "category": "Human", "name_of_medicine": "Cuprymina", "ema_product_number": "EMEA/H/C/002136", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0023", "international_non_proprietary_name_common_name": "copper (64Cu) chloride", "active_substance": "copper (64Cu) chloride", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "Not yet assigned", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Various diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cuprymina is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal product must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "A.C.O.M. - Advanced Center Oncology", "european_commission_decision_date": "01/07/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "30/04/2018", "last_updated_date": "01/07/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cuprymina" }, { "category": "Human", "name_of_medicine": "Memantine ratiopharm", "ema_product_number": "EMEA/H/C/002671", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0023", "international_non_proprietary_name_common_name": "memantine", "active_substance": "memantine hydrochloride", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with moderate to severe Alzheimer’s disease", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ratiopharm GmbH", "european_commission_decision_date": "03/06/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/06/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "24/07/2018", "last_updated_date": "30/06/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/memantine-ratiopharm" }, { "category": "Human", "name_of_medicine": "Starlix", "ema_product_number": "EMEA/H/C/000335", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0040", "international_non_proprietary_name_common_name": "nateglinide", "active_substance": "nateglinide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nateglinide is indicated for combination therapy with metformin in type-2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "08/11/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/04/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "08/05/2018", "last_updated_date": "28/06/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/starlix" }, { "category": "Human", "name_of_medicine": "Kiovig", "ema_product_number": "EMEA/H/C/000628", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0117", "international_non_proprietary_name_common_name": "human normal immunoglobulin", "active_substance": "human normal immunoglobulin (IVIg)", "therapeutic_area_mesh": "Purpura, Thrombocytopenic, Idiopathic;Bone Marrow Transplantation;Immunologic Deficiency Syndromes;Guillain-Barre Syndrome;Mucocutaneous Lymph Node Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immune sera and immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Replacement therapy in adults, and children and adolescents (0-18 years) in: primary immunodeficiency syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who have failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS and recurrent bacterial infections. Immunomodulation in adults, and children and adolescents (0-18 years) in: primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease; multifocal motor neuropathy (MMN).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Manufacturing Austria AG", "european_commission_decision_date": "24/06/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/01/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "07/06/2017", "last_updated_date": "27/06/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kiovig" }, { "category": "Human", "name_of_medicine": "Desloratadine ratiopharm", "ema_product_number": "EMEA/H/C/002404", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0030", "international_non_proprietary_name_common_name": "desloratadine", "active_substance": "desloratadine", "therapeutic_area_mesh": "Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R06AX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihistamines for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with: allergic rhinitis chronic idiopathic urticaria as initially diagnosed by a physician", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ratiopharm GmbH", "european_commission_decision_date": "22/06/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/11/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/01/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "29/11/2017", "last_updated_date": "24/06/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/desloratadine-ratiopharm" }, { "category": "Human", "name_of_medicine": "Sildenafil ratiopharm", "ema_product_number": "EMEA/H/C/001080", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0052", "international_non_proprietary_name_common_name": "sildenafil", "active_substance": "sildenafil", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for sildenafil to be effective, sexual stimulation is required.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ratiopharm GmbH", "european_commission_decision_date": "21/06/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/12/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "20/03/2018", "last_updated_date": "24/06/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sildenafil-ratiopharm" }, { "category": "Human", "name_of_medicine": "Sitoiganap", "ema_product_number": "EMEA/H/C/003693", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "autologous glioma tumor cell lysates (inactivated);allogeneic glioma tumor cell lysates (inactivated);allogeneic glioma tumor cells (inactivated);autologous glioma tumor cells (inactivated)", "active_substance": "allogeneic glioma tumor cell lysates (inactivated);allogeneic glioma tumor cells (inactivated);autologous glioma tumor cell lysates (inactivated);autologous glioma tumor cells (inactivated)", "therapeutic_area_mesh": "Glioma;Gliosarcoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of glioma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Epitopoietic Research Corporation-Belgium (E.R.C.)", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "02/05/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/05/2022", "last_updated_date": "17/06/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sitoiganap" }, { "category": "Human", "name_of_medicine": "Desloratadine Teva", "ema_product_number": "EMEA/H/C/002419", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00000962/202107", "international_non_proprietary_name_common_name": "desloratadine", "active_substance": "desloratadine", "therapeutic_area_mesh": "Rhinitis, Allergic, Perennial;Rhinitis, Allergic, Seasonal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R06AX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihistamines for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Desloratadine Teva is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V", "european_commission_decision_date": "30/05/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/09/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/11/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "13/03/2018", "last_updated_date": "09/06/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/desloratadine-teva" }, { "category": "Human", "name_of_medicine": "Dasselta", "ema_product_number": "EMEA/H/C/002310", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00000962/202107", "international_non_proprietary_name_common_name": "desloratadine", "active_substance": "desloratadine", "therapeutic_area_mesh": "Rhinitis, Allergic, Perennial;Rhinitis, Allergic, Seasonal;Urticaria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R06AX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihistamines for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dasselta is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "30/05/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/11/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "12/03/2018", "last_updated_date": "09/06/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dasselta" }, { "category": "Human", "name_of_medicine": "Amifampridine SERB", "ema_product_number": "EMEA/H/C/005839", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "amifampridine", "active_substance": "amifampridine phosphate", "therapeutic_area_mesh": "Lambert-Eaton Myasthenic Syndrome;Paraneoplastic Syndromes, Nervous System;Nervous System Neoplasms;Paraneoplastic Syndromes;Nervous System Diseases;Autoimmune Diseases of the Nervous System;Neurodegenerative Diseases;Neuromuscular Diseases;Neuromuscular Junction Diseases;Immune System Diseases;Autoimmune Diseases;Autoimmune Diseases of the Nervous System;Cancer;Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SERB SA", "european_commission_decision_date": "19/05/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/03/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/05/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/03/2022", "last_updated_date": "24/05/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amifampridine-serb" }, { "category": "Human", "name_of_medicine": "Ipique", "ema_product_number": "EMEA/H/C/005433", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Wet Macular Degeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neovascular (wet) age-related macular degeneration (AMD)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Rotterdam Biologics B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/12/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "29/04/2022", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/11/2021", "last_updated_date": "24/05/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ipique" }, { "category": "Human", "name_of_medicine": "Neffy", "ema_product_number": "EMEA/H/C/005584", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "epinephrine", "active_substance": "epinephrine", "therapeutic_area_mesh": "Hypersensitivity;Anaphylaxis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01CA24", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Emergency treatment of allergic reactions, including anaphylaxis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ars Pharmaceuticals Irl Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "04/04/2022", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/04/2022", "last_updated_date": "20/05/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neffy" }, { "category": "Human", "name_of_medicine": "Rasilez HCT", "ema_product_number": "EMEA/H/C/000964", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "aliskiren;hydrochlorothiazide", "active_substance": "aliskiren;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09XA52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension in adults. Rasilez HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Rasilez HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Noden Pharma DAC", "european_commission_decision_date": "20/12/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "27/08/2018", "last_updated_date": "20/05/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rasilez-hct" }, { "category": "Human", "name_of_medicine": "Docetaxel Zentiva (previously Docetaxel Winthrop)", "ema_product_number": "EMEA/H/C/000808", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "docetaxel", "active_substance": "docetaxel", "therapeutic_area_mesh": "Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Stomach Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Winthrop monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Winthrop in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Winthrop in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva k.s.", "european_commission_decision_date": "25/04/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/04/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "30", "first_published_date": "01/02/2018", "last_updated_date": "20/05/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/docetaxel-zentiva" }, { "category": "Human", "name_of_medicine": "Pregabalin Mylan Pharma", "ema_product_number": "EMEA/H/C/003962", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/2006", "international_non_proprietary_name_common_name": "pregabalin", "active_substance": "pregabalin", "therapeutic_area_mesh": "Anxiety Disorders;Neuralgia;Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Epilepsy Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan S.A.S.", "european_commission_decision_date": "14/01/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/06/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "09/03/2018", "last_updated_date": "26/04/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pregabalin-mylan-pharma" }, { "category": "Human", "name_of_medicine": "Zektayos - Hepjuvo", "ema_product_number": "EMEA/H/C/005249", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "obeticholic acid", "active_substance": "obeticholic acid", "therapeutic_area_mesh": "Fatty Liver", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A05AA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bile and liver therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Improvement of liver fibrosis and resolution of steatohepatitis in adult patients with significant liver fibrosis due to nonalcoholic steatohepatitis (NASH)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Advanz Pharma Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "09/12/2021", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/12/2021", "last_updated_date": "08/04/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zektayos-hepjuvo" }, { "category": "Human", "name_of_medicine": "Palonosetron Hospira", "ema_product_number": "EMEA/H/C/004069", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0005/G", "international_non_proprietary_name_common_name": "palonosetron", "active_substance": "palonosetron hydrochloride", "therapeutic_area_mesh": "Nausea;Vomiting;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A04AA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiemetics and antinauseants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Palonosetron Hospira is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy; the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Palonosetron Hospira is indicated in paediatric patients 1 month of age and older for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "12/12/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/04/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "01/02/2018", "last_updated_date": "08/04/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/palonosetron-hospira" }, { "category": "Human", "name_of_medicine": "Dukoral", "ema_product_number": "EMEA/H/C/000476", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0062/G", "international_non_proprietary_name_common_name": "cholera vaccine (inactivated, oral)", "active_substance": "recombinant cholera toxin B subunit;vibrio cholerae 01", "therapeutic_area_mesh": "Cholera;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dukoral is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas. The use of Dukoral should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions. Dukoral should not replace standard protective measures. In the event of diarrhoea measures of rehydration should be instituted.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Valneva Sweden AB", "european_commission_decision_date": "07/01/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/04/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "16/03/2015", "last_updated_date": "06/04/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dukoral" }, { "category": "Human", "name_of_medicine": "Skysona", "ema_product_number": "EMEA/H/C/003690", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "elivaldogene autotemcel", "active_substance": "elivaldogene autotemcel", "therapeutic_area_mesh": "Adrenoleukodystrophy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an ABCD1 genetic mutation, and for whom a human leukocyte antigen (HLA) matched sibling haematopoietic stem cell donor is not available.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "bluebird bio (Netherlands) B.V.", "european_commission_decision_date": "18/11/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/07/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/05/2021", "last_updated_date": "04/04/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/skysona" }, { "category": "Human", "name_of_medicine": "Stimufend", "ema_product_number": "EMEA/H/C/004780", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants;Colony stimulating factors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "28/03/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/01/2022", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/03/2022", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/01/2022", "last_updated_date": "04/04/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/stimufend" }, { "category": "Human", "name_of_medicine": "Tractocile", "ema_product_number": "EMEA/H/C/000253", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0077", "international_non_proprietary_name_common_name": "atosiban", "active_substance": "atosiban (as acetate)", "therapeutic_area_mesh": "Obstetric Labor, Premature", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G02CX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other gynecologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tractotile is indicated to delay imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 seconds duration at a rate of ? 4 per 30 minutes; a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ? 50%; a gestational age from 24 until 33 completed weeks; a normal foetal heart rate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ferring Pharmaceuticals A/S", "european_commission_decision_date": "30/03/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/01/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "24", "first_published_date": "23/06/2016", "last_updated_date": "30/03/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tractocile" }, { "category": "Human", "name_of_medicine": "Temomedac", "ema_product_number": "EMEA/H/C/001124", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0036", "international_non_proprietary_name_common_name": "temozolomide", "active_substance": "temozolomide", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01AX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Temomedac hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "european_commission_decision_date": "25/03/2022", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/01/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "01/06/2018", "last_updated_date": "28/03/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/temomedac" }, { "category": "Human", "name_of_medicine": "NovoThirteen", "ema_product_number": "EMEA/H/C/002284", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0026", "international_non_proprietary_name_common_name": "catridecacog", "active_substance": "catridecacog", "therapeutic_area_mesh": "Blood Coagulation Disorders, Inherited", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Long-term prophylactic treatment of bleeding in adult and paediatric patients 6 years and above with congenital factor-XIII-A-subunit deficiency.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "27/08/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/05/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/09/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "24/05/2017", "last_updated_date": "21/03/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/novothirteen" }, { "category": "Human", "name_of_medicine": "Vivanza", "ema_product_number": "EMEA/H/C/000488", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0063", "international_non_proprietary_name_common_name": "vardenafil", "active_substance": "vardenafil", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Vivanza to be effective, sexual stimulation is required. Vivanza is not indicated for use by women.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG ", "european_commission_decision_date": "20/10/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/03/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "28", "first_published_date": "19/04/2018", "last_updated_date": "28/02/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vivanza" }, { "category": "Veterinary", "name_of_medicine": "RenuTend", "ema_product_number": "EMEA/V/C/005428", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells", "active_substance": "tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Musculo-skeletal system;Other drugs for disorders of the musculo-skeletal system", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/02/2022", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/renutend" }, { "category": "Human", "name_of_medicine": "Leganto", "ema_product_number": "EMEA/H/C/002380", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1963", "international_non_proprietary_name_common_name": "rotigotine", "active_substance": "rotigotine", "therapeutic_area_mesh": "Restless Legs Syndrome;Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BC09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults. Leganto is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma S.A.  ", "european_commission_decision_date": "14/12/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/04/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/06/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "24/04/2018", "last_updated_date": "18/02/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/leganto" }, { "category": "Human", "name_of_medicine": "Raylumis", "ema_product_number": "EMEA/H/C/005189", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tanezumab", "active_substance": "tanezumab", "therapeutic_area_mesh": "Osteoarthritis;Pain", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of moderate to severe chronic pain associated with osteoarthritis (OA) of the hip or knee in adult patients for whom treatment with non-steroidal anti-inflammatory drugs (NSAIDs) and/or any opioid is ineffective, not tolerated or inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "15/11/2021", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/09/2021", "last_updated_date": "15/02/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/raylumis" }, { "category": "Human", "name_of_medicine": "Staquis", "ema_product_number": "EMEA/H/C/004863", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0006", "international_non_proprietary_name_common_name": "crisaborole", "active_substance": "Crisaborole", "therapeutic_area_mesh": "Dermatitis, Atopic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D11AH06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other dermatological preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Staquis is indicated for treatment of mild to moderate atopic dermatitis in adults and paediatric patients from 2 years of age with ? 40% body surface area (BSA) affected.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "01/10/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "30/01/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/03/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "22/04/2020", "last_updated_date": "08/02/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/staquis" }, { "category": "Veterinary", "name_of_medicine": "Imoxat", "ema_product_number": "EMEA/V/C/005597", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "imidacloprid;moxidectin", "active_substance": "imidacloprid;moxidectin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents, macrocyclic lactones, milbemycins", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/10/2021", "last_updated_date": "24/01/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/imoxat" }, { "category": "Human", "name_of_medicine": "Atripla", "ema_product_number": "EMEA/H/C/000797", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0150", "international_non_proprietary_name_common_name": "efavirenz;emtricitabine;tenofovir disoproxil", "active_substance": "efavirenz;emtricitabine;tenofovir disoproxil fumarate", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. It is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Atripla prior to initiation of their first antiretroviral treatment regimen. The demonstration of the benefit of Atripla is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to Atripla. No data are currently available from clinical studies with Atripla in treatment-naive or in heavily pretreated patients. No data are available to support the combination of Atripla and other antiretroviral agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences Ireland UC", "european_commission_decision_date": "17/08/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/12/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "25/07/2018", "last_updated_date": "21/01/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/atripla" }, { "category": "Human", "name_of_medicine": "Nouryant", "ema_product_number": "EMEA/H/C/005308", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "istradefylline", "active_substance": "Istradefylline", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Istradefylline is indicated in adults as an adjunctive treatment to levodopa based regimens in patients with Parkinson’s disease (PD) experiencing “OFF” time.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Kyowa Kirin Holdings B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/07/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "06/01/2022", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/07/2021", "last_updated_date": "19/01/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nouryant" }, { "category": "Human", "name_of_medicine": "Ytracis", "ema_product_number": "EMEA/H/C/000460", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0016", "international_non_proprietary_name_common_name": "yttrium [90Y] chloride", "active_substance": "yttrium (90Y) chloride", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "To be used only for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.Radiopharmaceutical precursor - Not intended for direct application to patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CIS bio international", "european_commission_decision_date": "29/05/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/03/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "29/05/2015", "last_updated_date": "19/01/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ytracis" }, { "category": "Human", "name_of_medicine": "Pantoloc Control", "ema_product_number": "EMEA/H/C/001100", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1891/G", "international_non_proprietary_name_common_name": "pantoprazole", "active_substance": "pantoprazole", "therapeutic_area_mesh": "Gastroesophageal Reflux", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A02BC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Proton pump inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda GmbH", "european_commission_decision_date": "14/01/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/02/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/06/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "25/06/2018", "last_updated_date": "18/01/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pantoloc-control" }, { "category": "Human", "name_of_medicine": "Ebixa", "ema_product_number": "EMEA/H/C/000463", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0094", "international_non_proprietary_name_common_name": "memantine", "active_substance": "memantine hydrochloride", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other anti-dementia drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with moderate to severe Alzheimer's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "H. Lundbeck A/S", "european_commission_decision_date": "17/12/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/05/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "14/10/2016", "last_updated_date": "05/01/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ebixa" }, { "category": "Veterinary", "name_of_medicine": "Hydrocortisone aceponate Ecuphar (previously Cortacare)", "ema_product_number": "EMEA/V/C/004689", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "hydrocortisone aceponate", "active_substance": "hydrocortisone aceponate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Corticosteroids, dermatological preparations", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/06/2018", "last_updated_date": "04/01/2022", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/hydrocortisone-aceponate-ecuphar" }, { "category": "Human", "name_of_medicine": "Livmarli", "ema_product_number": "EMEA/H/C/005551", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "maralixibat", "active_substance": "Maralixibat chloride", "therapeutic_area_mesh": "Cholestasis, Intrahepatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A05AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bile and liver therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of progressive familial intrahepatic cholestasis type 2 (PFIC2)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "FGK Representative Service GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "23/08/2021", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/09/2021", "last_updated_date": "17/12/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/livmarli-0" }, { "category": "Human", "name_of_medicine": "Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)", "ema_product_number": "EMEA/H/C/005734", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0004", "international_non_proprietary_name_common_name": "lenalidomide", "active_substance": "lenalidomide hydrochloride monohydrate", "therapeutic_area_mesh": "Multiple Myeloma;Lymphoma, Follicular", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Multiple myelomaLenalidomide krka d.d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide krka d.d. Novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide krka d.d. Novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphomaLenalidomide krka d.d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). Multiple myelomaLenalidomide krka d.d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide krka d.d. Novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide krka d.d. Novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphomaLenalidomide krka d.d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto ", "european_commission_decision_date": "13/12/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "18/02/2021", "last_updated_date": "17/12/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-krka-dd-novo-mesto" }, { "category": "Human", "name_of_medicine": "Docetaxel Teva", "ema_product_number": "EMEA/H/C/001107", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0030", "international_non_proprietary_name_common_name": "docetaxel", "active_substance": "docetaxel", "therapeutic_area_mesh": "Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Stomach Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Docetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Teva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Teva in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Teva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Teva in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V. ", "european_commission_decision_date": "28/04/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/01/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "25/06/2018", "last_updated_date": "14/12/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/docetaxel-teva" }, { "category": "Human", "name_of_medicine": "Marixino (previously Maruxa)", "ema_product_number": "EMEA/H/C/002658", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0015", "international_non_proprietary_name_common_name": "memantine", "active_substance": "memantine hydrochloride", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other anti-dementia drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with moderate to severe Alzheimer’s disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "KRKA, d.d.", "european_commission_decision_date": "06/12/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/01/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/04/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "04/04/2018", "last_updated_date": "08/12/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/marixino" }, { "category": "Veterinary", "name_of_medicine": "Increxxa", "ema_product_number": "EMEA/V/C/005305", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tulathromycin", "active_substance": "tulathromycin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/12/2020", "last_updated_date": "08/12/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/increxxa" }, { "category": "Human", "name_of_medicine": "Flynpovi", "ema_product_number": "EMEA/H/C/005043", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "eflornithine;sulindac", "active_substance": "eflornithine hydrochloride;sulindac", "therapeutic_area_mesh": "Adenomatous Polyposis Coli", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adults patients with familial adenomatous polyposis (FAP)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cancer Prevention Pharma (Ireland) Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "12/10/2021", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/11/2021", "last_updated_date": "07/12/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/flynpovi" }, { "category": "Human", "name_of_medicine": "Zynyz", "ema_product_number": "EMEA/H/C/005632", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "retifanlimab", "active_substance": "retifanlimab", "therapeutic_area_mesh": "Anus Neoplasms;Carcinoma, Squamous Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on or who are intolerant of platinum-based chemotherapy", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Incyte Biosciences Distribution B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "14/10/2021", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/10/2021", "last_updated_date": "29/11/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zynyz-0" }, { "category": "Human", "name_of_medicine": "Pemetrexed Lilly", "ema_product_number": "EMEA/H/C/004114", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0013", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Mesothelioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Malignant pleural mesothelioma Pemetrexed Lilly in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Lilly in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Lilly is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Lilly is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non small cell lung cancer other than predominantly squamous cell histology.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Netherlands", "european_commission_decision_date": "18/06/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/09/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "26/04/2017", "last_updated_date": "26/11/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-lilly" }, { "category": "Human", "name_of_medicine": "Equidacent", "ema_product_number": "EMEA/H/C/005181", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0004", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Colorectal Neoplasms;Breast Neoplasms;Ovarian Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Equidacent in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Centus Biotherapeutics Europe Limited", "european_commission_decision_date": "27/05/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/07/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/09/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "12/10/2020", "last_updated_date": "25/11/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/equidacent" }, { "category": "Veterinary", "name_of_medicine": "Coliprotec F4", "ema_product_number": "EMEA/V/C/003797", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0005", "international_non_proprietary_name_common_name": "Escherichia coli, type 08, strain K87 (live)", "active_substance": "live non-pathogenic Escherichia coli O8:K87", "therapeutic_area_mesh": "", "species_veterinary": "Pigs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI09AE03", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Live bacterial vaccines;Pig", "therapeutic_indication": "For active immunisation of pigs against enterotoxigenic F4-positive Escherichia coli in order to: reduce the incidence of moderate to severe post-weaning Escherichia coli diarrhoea (PWD) in pigs; reduce the colonisation of the ileum and faecal shedding of enterotoxigenic F4-positive Escherichia coli from infected pigs.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Prevtec Microbia GmbH", "european_commission_decision_date": "15/01/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/03/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "22/12/2015", "last_updated_date": "23/11/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/coliprotec-f4" }, { "category": "Human", "name_of_medicine": "Telmisartan Teva Pharma", "ema_product_number": "EMEA/H/C/002511", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0024", "international_non_proprietary_name_common_name": "telmisartan", "active_substance": "telmisartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "08/10/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/10/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "09/06/2016", "last_updated_date": "26/10/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/telmisartan-teva-pharma" }, { "category": "Human", "name_of_medicine": "CureVac’s COVID-19 vaccine (CVnCoV)", "ema_product_number": "EMEA/H/C/005845", "medicine_status": "Withdrawn from rolling review", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "COVID-19 mRNA vaccine", "active_substance": "single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "COVID-19 Vaccine", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CureVac AG", "european_commission_decision_date": "", "start_of_rolling_review_date": "12/02/2021", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "11/10/2021", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "11/10/2021", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/10/2021", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/curevacs-covid-19-vaccine-cvncov" }, { "category": "Human", "name_of_medicine": "Oportuzumab monatox DLRC Pharma Services", "ema_product_number": "EMEA/H/C/005730", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "oportuzumab monatox", "active_substance": "oportuzumab monatox", "therapeutic_area_mesh": "Urologic Neoplasms;Urinary Bladder Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prevention of recurrence of carcinoma-in-situ (CIS) of the urinary bladder and prevention of recurrence of high grade Ta and/or T1 papillary tumours", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "DLRC Pharma Services Ltd", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/08/2021", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/09/2021", "last_updated_date": "20/10/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/oportuzumab-monatox-dlrc-pharma-services" }, { "category": "Human", "name_of_medicine": "Inductos", "ema_product_number": "EMEA/H/C/000408", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0100", "international_non_proprietary_name_common_name": "dibotermin alfa", "active_substance": "dibotermin alfa", "therapeutic_area_mesh": "Tibial Fractures;Fracture Fixation, Internal;Spinal Fusion", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Inductos is indicated for single level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non operative treatment for this condition. Inductos is indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Medtronic BioPharma B.V.", "european_commission_decision_date": "02/09/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/09/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "17/08/2018", "last_updated_date": "18/10/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/inductos" }, { "category": "Human", "name_of_medicine": "Sildenafil FGK", "ema_product_number": "EMEA/H/C/005439", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "sildenafil", "active_substance": "sildenafil citrate", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of erectile dysfunction", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "FGK Representative Service GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "19/07/2021", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/09/2021", "last_updated_date": "05/10/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sildenafil-fgk" }, { "category": "Human", "name_of_medicine": "Entacapone Teva", "ema_product_number": "EMEA/H/C/002075", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0018", "international_non_proprietary_name_common_name": "entacapone", "active_substance": "entacapone", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "10/09/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/11/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/02/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "30/03/2016", "last_updated_date": "28/09/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/entacapone-teva" }, { "category": "Human", "name_of_medicine": "Raloxifene Teva", "ema_product_number": "EMEA/H/C/001075", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0029", "international_non_proprietary_name_common_name": "raloxifene", "active_substance": "raloxifene hydrochloride", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03XC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "08/09/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/02/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/04/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "07/09/2016", "last_updated_date": "27/09/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/raloxifene-teva" }, { "category": "Human", "name_of_medicine": "Fiasp", "ema_product_number": "EMEA/H/C/004046", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0028", "international_non_proprietary_name_common_name": "insulin aspart", "active_substance": "insulin aspart", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Insulins and analogues for injection, fast-acting", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "18/08/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/11/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/01/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "12/04/2018", "last_updated_date": "23/09/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fiasp" }, { "category": "Human", "name_of_medicine": "Telmisartan Teva", "ema_product_number": "EMEA/H/C/001146", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0027", "international_non_proprietary_name_common_name": "telmisartan", "active_substance": "telmisartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension in adults", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "09/02/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/01/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "25/07/2018", "last_updated_date": "17/09/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/telmisartan-teva" }, { "category": "Human", "name_of_medicine": "Teriparatide Cinnagen", "ema_product_number": "EMEA/H/C/005543", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "teriparatide", "active_substance": "teriparatide", "therapeutic_area_mesh": "Osteoporosis;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CinnaGen Co Unipessoal LDA", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "09/09/2021", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/09/2021", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/teriparatide-cinnagen" }, { "category": "Human", "name_of_medicine": "Caspofungin Accord", "ema_product_number": "EMEA/H/C/004134", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0010", "international_non_proprietary_name_common_name": "caspofungin", "active_substance": "caspofungin acetate", "therapeutic_area_mesh": "Candidiasis;Aspergillosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of invasive candidiasis in adult or paediatric patients. Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "06/02/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/02/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "20/12/2016", "last_updated_date": "20/08/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/caspofungin-accord" }, { "category": "Veterinary", "name_of_medicine": "Porcilis Pesti", "ema_product_number": "EMEA/V/C/000046", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0011", "international_non_proprietary_name_common_name": "adjuvanted vaccine against classical swine fever", "active_substance": "Classical Swine Fever Virus (CSFV) -E2 subunit antigen", "therapeutic_area_mesh": "", "species_veterinary": "Pigs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI09AD04", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae", "therapeutic_indication": "Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.The onset of protection is 2 weeks.The duration of protection is 6 months.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "16/09/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/06/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "16/09/2011", "last_updated_date": "19/08/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/porcilis-pesti" }, { "category": "Human", "name_of_medicine": "Ritemvia", "ema_product_number": "EMEA/H/C/004725", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1859/G", "international_non_proprietary_name_common_name": "rituximab", "active_substance": "rituximab", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin;Microscopic Polyangiitis;Wegener Granulomatosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ritemvia is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Ritemvia is indicated for the treatment of previously untreated patients with stage III, IV follicular lymphoma in combination with chemotherapy. Ritemvia maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Ritemvia monotherapy is indicated for treatment of patients with stage III, IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy. Ritemvia is indicated for the treatment of patients with CD20 positive diffuse large B cell non Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Granulomatosis with polyangiitis and microscopic polyangiitis. Ritemvia, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "09/10/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/05/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "17/05/2018", "last_updated_date": "16/08/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ritemvia" }, { "category": "Human", "name_of_medicine": "Lumoxiti", "ema_product_number": "EMEA/H/C/005322", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "moxetumomab pasudotox", "active_substance": "moxetumomab pasudotox", "therapeutic_area_mesh": "Leukemia, Hairy Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lumoxiti as monotherapy is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) after receiving at least two prior systemic therapies, including treatment with a purine nucleoside analogue (PNA).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "23/07/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "10/12/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/02/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/03/2021", "last_updated_date": "11/08/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lumoxiti" }, { "category": "Human", "name_of_medicine": "Azacitidine Celgene", "ema_product_number": "EMEA/H/C/005300", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WITHDRAWAL", "international_non_proprietary_name_common_name": "azacitidine", "active_substance": "azacitidine", "therapeutic_area_mesh": "Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Azacitidine Celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification, AML with >30% marrow blasts according to the WHO classification.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celgene Europe BV", "european_commission_decision_date": "21/05/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/08/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "14/08/2019", "last_updated_date": "04/08/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/azacitidine-celgene" }, { "category": "Human", "name_of_medicine": "Pemetrexed Pfizer (previously Pemetrexed Hospira UK Limited)", "ema_product_number": "EMEA/H/C/004488", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed ditromethamine", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Mesothelioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "ANTIMETABOLITES;Folic acid analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Malignant pleural mesothelioma Pemetrexed Hospira UK Limited in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Hospira UK Limited in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see SmPC section 5.1). Pemetrexed Hospira UK Limited is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see SmPC section 5.1). Pemetrexed Hospira UK Limited is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see SmPC section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "21/10/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/02/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/04/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "24/04/2018", "last_updated_date": "29/07/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-pfizer-previously-pemetrexed-hospira-uk-limited" }, { "category": "Human", "name_of_medicine": "Portrazza", "ema_product_number": "EMEA/H/C/003886", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WITHDRAWAL", "international_non_proprietary_name_common_name": "necitumumab", "active_substance": "necitumumab", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "18/02/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/02/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "10/11/2016", "last_updated_date": "27/07/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/portrazza" }, { "category": "Human", "name_of_medicine": "Levemir", "ema_product_number": "EMEA/H/C/000528", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0101", "international_non_proprietary_name_common_name": "insulin detemir", "active_substance": "Insulin detemir", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "09/04/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2004", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/06/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "29", "first_published_date": "09/04/2018", "last_updated_date": "13/07/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levemir" }, { "category": "Human", "name_of_medicine": "Ulipristal Acetate Gedeon Richter", "ema_product_number": "EMEA/H/C/005017", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ulipristal acetate", "active_substance": "ulipristal acetate", "therapeutic_area_mesh": "Leiomyoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03XB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "14/06/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/06/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/08/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "27/08/2018", "last_updated_date": "09/07/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ulipristal-acetate-gedeon-richter" }, { "category": "Human", "name_of_medicine": "Ribavirin Teva Pharma B.V.", "ema_product_number": "EMEA/H/C/001064", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0023", "international_non_proprietary_name_common_name": "ribavirin", "active_substance": "ribavirin", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AP01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1). Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation (see sections 4.2, 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "22/06/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/06/2021", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "04/11/2016", "last_updated_date": "09/07/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ribavirin-teva-pharma-bv" }, { "category": "Human", "name_of_medicine": "Ribavirin Teva", "ema_product_number": "EMEA/H/C/001018", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0023", "international_non_proprietary_name_common_name": "ribavirin", "active_substance": "ribavirin", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ribavirin Teva is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used. There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e. not alfa-2b). Naïve patients Adult patients Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA. Paediatric patients (children 3 years of age and older and adolescents) Ribavirin Teva is indicated, in a combination regimen with interferon alfa­2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis. Previous treatment failure patients Adult patients Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "22/06/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/03/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/06/2021", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "14/11/2016", "last_updated_date": "09/07/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ribavirin-teva" }, { "category": "Veterinary", "name_of_medicine": "Kexxtone", "ema_product_number": "EMEA/V/C/002235", "medicine_status": "Suspended", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "monensin", "active_substance": "monensin (as monensin sodium)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QA16QA06", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Drugs for prevention and/or treatment of acetonemia", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/12/2017", "last_updated_date": "25/06/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/kexxtone" }, { "category": "Human", "name_of_medicine": "Nodetrip (previously Xeristar)", "ema_product_number": "EMEA/H/C/000573", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WITHDRAWAL", "international_non_proprietary_name_common_name": "duloxetine", "active_substance": "duloxetine", "therapeutic_area_mesh": "Anxiety Disorders;Depressive Disorder, Major;Diabetic Neuropathies", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of major depressive disorder; Treatment of diabetic peripheral neuropathic pain; Treatment of generalised anxiety disorder; Xeristar is indicated in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Esteve Pharmaceuticals, S.A.", "european_commission_decision_date": "12/05/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/09/2004", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/12/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "12/05/2021", "suspension_of_marketing_authorisation_date": "", "revision_number": "32", "first_published_date": "09/12/2016", "last_updated_date": "22/06/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nodetrip" }, { "category": "Human", "name_of_medicine": "PegIntron", "ema_product_number": "EMEA/H/C/000280", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0135", "international_non_proprietary_name_common_name": "peginterferon alfa-2b", "active_substance": "peginterferon alfa-2b", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults (tritherapy) PegIntron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-C (CHC) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Please refer to the ribavirin and boceprevir summaries of product characteristics (SmPCs) when PegIntron is to be used in combination with these medicines. Adults (bitherapy and monotherapy) PegIntron is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis-C-virus RNA (HCV-RNA), including patients with compensated cirrhosis and / or co-infected with clinically stable HIV. PegIntron in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon-alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon-alpha monotherapy. Interferon monotherapy, including PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin. Please refer to the ribavirin SmPC when PegIntron is to be used in combination with ribavirin. Paediatric population (bitherapy) PegIntron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have CHC, previously untreated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case-by-case basis. Please refer to the ribavirin SmPC for capsules or oral solution when PegIntron is to be used in combination with ribavirin.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "21/04/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/05/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "21/04/2021", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "22/06/2017", "last_updated_date": "03/06/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pegintron" }, { "category": "Human", "name_of_medicine": "NovoEight", "ema_product_number": "EMEA/H/C/002719", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0035", "international_non_proprietary_name_common_name": "turoctocog alfa", "active_substance": "turoctocog alfa", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "coagulation factor VIII", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Novoeight can be used for all age groups.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "01/10/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/11/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "30/07/2018", "last_updated_date": "19/05/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/novoeight" }, { "category": "Veterinary", "name_of_medicine": "Spironolactone Ceva", "ema_product_number": "EMEA/V/C/000105", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0014", "international_non_proprietary_name_common_name": "spironolactone", "active_substance": "spironolactone", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QC03DA01", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Diuretics", "therapeutic_indication": "For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ceva Santé Animale", "european_commission_decision_date": "31/10/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/04/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/06/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "31/10/2012", "last_updated_date": "10/05/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/spironolactone-ceva" }, { "category": "Human", "name_of_medicine": "Tibsovo", "ema_product_number": "EMEA/H/C/005056", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ivosidenib", "active_substance": "Ivosidenib", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX62", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) and locally advanced or metastatic cholangiocarcinoma", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Agios Netherlands B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/10/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/11/2020", "last_updated_date": "16/04/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tibsovo-0" }, { "category": "Veterinary", "name_of_medicine": "Acticam", "ema_product_number": "EMEA/V/C/000138", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0023", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "Dogs;Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QM01AC06", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Oral suspension: Dogs: Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders. Solution for injection: Dogs: Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders. Reduction of postoperative pain and inflammation following orthopaedic and soft-tissue surgery. Cats: Reduction of postoperative pain after ovariohysterectomy and minor soft-tissue surgery.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ecuphar", "european_commission_decision_date": "22/03/2021", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/10/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "09/12/2013", "last_updated_date": "24/03/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/acticam" }, { "category": "Human", "name_of_medicine": "Gamifant", "ema_product_number": "EMEA/H/C/004386", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "emapalumab", "active_substance": "emapalumab", "therapeutic_area_mesh": "Immune System Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA39", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Gamifant is indicated for the treatment of paediatric patients aged under 18 years with primary haemophagocytic lymphohistiocytosis (HLH).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "Yes", "marketing_authorisation_developer_applicant_holder": "Swedish Orphan Biovitrum AB (publ)", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/09/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "07/01/2021", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/03/2021", "last_updated_date": "23/03/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gamifant" }, { "category": "Human", "name_of_medicine": "Dexamethasone Taw", "ema_product_number": "EMEA/H/C/005740", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dexamethasone phosphate", "active_substance": "Dexamethasone (sodium phosphate)", "therapeutic_area_mesh": "COVID-19 virus infection;Brain Edema;Respiratory Distress Syndrome, Adult;Asthma;Skin Diseases;Autoimmune Diseases;Arthritis;Vomiting;Inflammation;Eye Diseases;Postoperative Nausea and Vomiting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H02AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Corticosteroids for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated for cerebral oedema, post-traumatic shock-lung syndrome, asthma, skin diseases, autoimmune diseases, rheumatoid arthritis, prophylaxis and treatment of post-operative or cytostatic-induced vomiting, treatment of COVID-19, eye inflammation and infection.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Taw Pharma (Ireland) Ltd", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/01/2021", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/01/2021", "last_updated_date": "19/03/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dexamethasone-taw" }, { "category": "Human", "name_of_medicine": "Truberzi", "ema_product_number": "EMEA/H/C/004098", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0013", "international_non_proprietary_name_common_name": "eluxadoline", "active_substance": "eluxadoline", "therapeutic_area_mesh": "Irritable Bowel Syndrome;Diarrhea", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antidiarrheals, intestinal antiinflammatory / antiinfective agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS D).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Allergan Pharmaceuticals International Limited", "european_commission_decision_date": "12/02/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/07/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/12/2020", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "08/12/2017", "last_updated_date": "25/02/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/truberzi" }, { "category": "Human", "name_of_medicine": "Lextemy", "ema_product_number": "EMEA/H/C/005611", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Colorectal Neoplasms;Breast Neoplasms;Ovarian Neoplasms;Fallopian Tube Neoplasms;Peritoneal Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Uterine Cervical Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan IRE Healthcare Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/02/2021", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "21/06/2021", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/02/2021", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lextemy" }, { "category": "Veterinary", "name_of_medicine": "Incurin", "ema_product_number": "EMEA/V/C/000047", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "estriol", "active_substance": "estriol", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Sex hormones and modulators of the genital system", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/08/2014", "last_updated_date": "24/02/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/incurin" }, { "category": "Human", "name_of_medicine": "Prepandrix", "ema_product_number": "EMEA/H/C/000822", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0077", "international_non_proprietary_name_common_name": "prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)", "active_substance": "A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunisation against H5N1 subtype of influenza-A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. Prepandrix should be used in accordance with official guidance.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "20/09/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/05/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "17/12/2020", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "28/11/2017", "last_updated_date": "23/02/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prepandrix" }, { "category": "Human", "name_of_medicine": "Enzepi", "ema_product_number": "EMEA/H/C/002070", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/01", "international_non_proprietary_name_common_name": "pancreas powder", "active_substance": "pancreas powder", "therapeutic_area_mesh": "Exocrine Pancreatic Insufficiency", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A09AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Digestives, incl. enzymes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pancreatic enzyme replacement treatment in exocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer).Enzepi is indicated in infants, children, adolescents and adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Allergan Pharmaceuticals International Limited", "european_commission_decision_date": "02/09/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/06/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "19/07/2021", "revision_number": "1", "first_published_date": "02/09/2016", "last_updated_date": "17/02/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enzepi" }, { "category": "Human", "name_of_medicine": "Udenyca", "ema_product_number": "EMEA/H/C/004413", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00002326/201901", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants;Colony stimulating factors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ERA Consulting GmbH", "european_commission_decision_date": "22/11/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "04/02/2021", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "27/07/2018", "last_updated_date": "15/02/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/udenyca" }, { "category": "Veterinary", "name_of_medicine": "Proteq West Nile", "ema_product_number": "EMEA/V/C/002005", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1279", "international_non_proprietary_name_common_name": "West Nile fever vaccine (live recombinant)", "active_substance": "West Nile recombinant canarypox virus (vCP2017 virus)", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/05/2016", "last_updated_date": "15/02/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/proteq-west-nile" }, { "category": "Human", "name_of_medicine": "Halimatoz", "ema_product_number": "EMEA/H/C/004866", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1290", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Hidradenitis Suppurativa;Psoriasis;Arthritis, Juvenile Rheumatoid;Uveitis;Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Halimatoz in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Halimatoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Halimatoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Halimatoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Halimatoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Axial spondyloarthritis Ankylosing spondylitis (AS) Halimatoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Halimatoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Halimatoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Halimatoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Halimatoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Halimatoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Halimatoz is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Halimatoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis/ Uveitis/ Paediatric uveitis For full indication see 4.1.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "18/12/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/05/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/07/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/12/2020", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "26/07/2018", "last_updated_date": "29/01/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/halimatoz" }, { "category": "Human", "name_of_medicine": "Clopidogrel ratiopharm GmbH", "ema_product_number": "EMEA/H/C/001165", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0036", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Acute Coronary Syndrome;Myocardial Infarction;Stroke", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease; patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q wave-myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Archie Samiel s.r.o.", "european_commission_decision_date": "22/08/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/01/2020", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "13/04/2018", "last_updated_date": "25/01/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-ratiopharm-gmbh" }, { "category": "Veterinary", "name_of_medicine": "Velactis", "ema_product_number": "EMEA/V/C/003739", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "cabergoline", "active_substance": "cabergoline", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QG02CB03", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Genito urinary system and sex hormones;Other gynecologicals;Prolactine inhibitors", "therapeutic_indication": "For use in the herd management programme of dairy cows as an aid in the abrupt drying-off by reducing milk production to: reduce milk leakage at drying off; reduce the risk of new intramammary infections during the dry period; reduce discomfort.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ceva Santé Animale", "european_commission_decision_date": "11/12/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/12/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "22/08/2016", "last_updated_date": "25/01/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/velactis" }, { "category": "Human", "name_of_medicine": "ViraferonPeg", "ema_product_number": "EMEA/H/C/000329", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0128", "international_non_proprietary_name_common_name": "peginterferon alfa-2b", "active_substance": "peginterferon alfa-2b", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults (tritherapy) ViraferonPeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-C (CHC) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Please refer to the ribavirin and boceprevir summaries of product characteristics (SmPCs) when ViraferonPeg is to be used in combination with these medicines. Adults (bitherapy and monotherapy) ViraferonPeg is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis-C-virus RNA (HCV-RNA), including patients with compensated cirrhosis and / or co-infected with clinically stable HIV. ViraferonPeg in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon alpha monotherapy. Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin. Please refer to the ribavirin SmPC when ViraferonPeg is to be used in combination with ribavirin. Paediatric population (bitherapy) ViraferonPeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis C, previously untreated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case-by-case basis. Please refer to the ribavirin SmPC for capsules or oral solution when ViraferonPeg is to be used in combination with ribavirin.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp Dohme Ltd ", "european_commission_decision_date": "27/09/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/02/2000", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/05/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "11/01/2021", "suspension_of_marketing_authorisation_date": "", "revision_number": "36", "first_published_date": "22/06/2017", "last_updated_date": "22/01/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/viraferonpeg" }, { "category": "Human", "name_of_medicine": "Qutavina", "ema_product_number": "EMEA/H/C/005388", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "teriparatide", "active_substance": "teriparatide", "therapeutic_area_mesh": "Osteoporosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Qutavina is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "EuroGenerics Holdings B.V.", "european_commission_decision_date": "24/11/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/08/2020", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "24/11/2020", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/01/2021", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qutavina" }, { "category": "Human", "name_of_medicine": "Puldysa", "ema_product_number": "EMEA/H/C/005123", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "idebenone", "active_substance": "idebenone;titanium dioxide", "therapeutic_area_mesh": "Muscular Dystrophy, Duchenne", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06BX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) not using glucocorticoids", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Santhera Pharmaceuticals (Deutschland) GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "28/10/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/11/2020", "last_updated_date": "18/01/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/puldysa" }, { "category": "Human", "name_of_medicine": "Sebivo", "ema_product_number": "EMEA/H/C/000713", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0050", "international_non_proprietary_name_common_name": "telbivudine", "active_substance": "telbivudine", "therapeutic_area_mesh": "Hepatitis B, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Nucleoside and nucleotide reverse transcriptase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. Initiation of Sebivo treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "12/04/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/04/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "12/04/2018", "last_updated_date": "14/01/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sebivo" }, { "category": "Human", "name_of_medicine": "Panretin", "ema_product_number": "EMEA/H/C/000279", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0045", "international_non_proprietary_name_common_name": "alitretinoin", "active_substance": "alitretinoin", "therapeutic_area_mesh": "Sarcoma, Kaposi", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with acquired-immune-deficiency-syndrome (AIDS)-related Kaposi's sarcoma (KS) when: lesions are not ulcerated or lymphoedematous, and; treatment of visceral KS is not required, and; lesions are not responding to systemic antiretroviral therapy, and; radiotherapy or chemotherapy are not appropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eisai GmbH", "european_commission_decision_date": "24/01/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/10/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "21/06/2018", "last_updated_date": "11/01/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/panretin" }, { "category": "Human", "name_of_medicine": "Turalio", "ema_product_number": "EMEA/H/C/004832", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pexidartinib", "active_substance": "pexidartinib", "therapeutic_area_mesh": "Giant Cell Tumor of Tendon Sheath;Synovitis, Pigmented Villonodular", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of tenosynovial giant cell tumour.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Daiichi Sankyo Europe GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/06/2020", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "28/10/2020", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/12/2020", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/turalio" }, { "category": "Human", "name_of_medicine": "Artobend", "ema_product_number": "EMEA/H/C/004598", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "autologous human chondrocytes in vitro expanded", "active_substance": "autologous human chondrocytes in vitro expanded", "therapeutic_area_mesh": "Fractures, Cartilage", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Repair of cartilage defects of the knee joint.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "TETEC Tissue Engineering Technologies AG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "18/11/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/12/2020", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/artobend" }, { "category": "Human", "name_of_medicine": "Alpivab", "ema_product_number": "EMEA/H/C/004299", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0004", "international_non_proprietary_name_common_name": "peramivir", "active_substance": "peramivir", "therapeutic_area_mesh": "Influenza, Human", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Alpivab is indicated for the treatment of uncomplicated influenza in adults and children from the age of 2 years.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biocryst", "european_commission_decision_date": "20/11/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/04/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "13/04/2018", "last_updated_date": "09/12/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alpivab" }, { "category": "Human", "name_of_medicine": "Silapo", "ema_product_number": "EMEA/H/C/000760", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0061", "international_non_proprietary_name_common_name": "epoetin zeta", "active_substance": "epoetin zeta", "therapeutic_area_mesh": "Anemia;Blood Transfusion, Autologous;Cancer;Kidney Failure, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis. Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre?existing anaemia at the start of chemotherapy). Silapo can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). Silapo is indicated for non-iron deficient adults prior to major elective orthopaedic surgery having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 ml). Silapo can be used to increase haemoglobin concentration in symptomatic anaemia (haemoglobin concentration of ?10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/ml).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stada Arzneimittel AG", "european_commission_decision_date": "05/11/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/12/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "26/09/2017", "last_updated_date": "25/11/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/silapo" }, { "category": "Veterinary", "name_of_medicine": "Zulvac 8 Bovis", "ema_product_number": "EMEA/V/C/000145", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/0747", "international_non_proprietary_name_common_name": "inactivated bluetongue virus, serotype 8", "active_substance": "inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02", "therapeutic_area_mesh": "", "species_veterinary": "Cattle", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI02AA08", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "Active immunisation of cattle from three months of age for the prevention of viraemia caused by bluetongue virus, serotype 8.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zoetis Belgium", "european_commission_decision_date": "23/03/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/01/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "23/03/2017", "last_updated_date": "24/11/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zulvac-8-bovis" }, { "category": "Human", "name_of_medicine": "Insulatard", "ema_product_number": "EMEA/H/C/000441", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1901", "international_non_proprietary_name_common_name": "insulin human (rDNA)", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "24/09/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/10/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "26/04/2018", "last_updated_date": "23/11/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/insulatard" }, { "category": "Human", "name_of_medicine": "Ribavirin Mylan (previously Ribavirin Three Rivers)", "ema_product_number": "EMEA/H/C/001185", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0030", "international_non_proprietary_name_common_name": "ribavirin", "active_substance": "ribavirin", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ribavirin Mylan is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). Ribavirin monotherapy must not be used. There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b). Please refer also to the interferon alfa-2b summary of product characteristics (SmPC) for prescribing information particular to that product. Naïve patients Adult patients Ribavirin Mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum hepatitis-C-virus (HCV) RNA. Children and adolescents Ribavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum HCV RNA. When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case-by-case basis (see section 4.4). Previously treatment-failure patients Adult patients Ribavirin Mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan S.A.S", "european_commission_decision_date": "13/03/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/06/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "29/07/2016", "last_updated_date": "23/11/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ribavirin-mylan" }, { "category": "Human", "name_of_medicine": "Roctavian", "ema_product_number": "EMEA/H/C/004749", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "valoctocogene roxaparvovec", "active_substance": "valoctocogene roxaparvovec", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of haemophilia A", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioMarin International Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "04/11/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/11/2020", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/roctavian-0" }, { "category": "Human", "name_of_medicine": "Vepacel", "ema_product_number": "EMEA/H/C/002089", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0019", "international_non_proprietary_name_common_name": "prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)", "active_substance": "Influenza virus (whole virion, inactivated), containing antigen of: A/Vietnam/1203/2004 (H5N1)", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Influenza vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunisation against H5N1 subtype of influenza A virus. This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. Vepacel should be used in accordance with Official guidance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ology Bioservices Ireland LTD", "european_commission_decision_date": "11/01/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/02/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "10/03/2017", "last_updated_date": "28/10/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vepacel" }, { "category": "Human", "name_of_medicine": "Upkanz", "ema_product_number": "EMEA/H/C/005004", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "deferiprone", "active_substance": "Deferiprone", "therapeutic_area_mesh": "Pantothenate Kinase-Associated Neurodegeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neurodegeneration with brain iron accumulation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Apotex B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "10/08/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/09/2020", "last_updated_date": "28/10/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/upkanz" }, { "category": "Human", "name_of_medicine": "Protaphane", "ema_product_number": "EMEA/H/C/000442", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1901", "international_non_proprietary_name_common_name": "insulin human (rDNA)", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "24/09/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2002", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/10/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "26/04/2018", "last_updated_date": "27/10/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/protaphane" }, { "category": "Human", "name_of_medicine": "Abilify MyCite", "ema_product_number": "EMEA/H/C/005062", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "aripiprazole", "active_substance": "aripiprazole", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "aripiprazole", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of schizophrenia, or of moderate to severe manic episodes in bipolar I disorder with sensor to measure medication adherence", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Otsuka Pharmaceutical Netherlands B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/07/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/07/2020", "last_updated_date": "22/10/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abilify-mycite" }, { "category": "Human", "name_of_medicine": "Rayoqta", "ema_product_number": "EMEA/H/C/005103", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "abicipar pegol", "therapeutic_area_mesh": "Macular Degeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals;Antineovascularisation agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Abicipar Pegol Allergan is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (AMD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Allergan Pharmaceuticals International Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/07/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/07/2020", "last_updated_date": "21/10/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rayoqta" }, { "category": "Human", "name_of_medicine": "Actrapid", "ema_product_number": "EMEA/H/C/000424", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1901", "international_non_proprietary_name_common_name": "human insulin (rDNA)", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "24/09/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/10/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "14/03/2018", "last_updated_date": "21/10/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/actrapid" }, { "category": "Human", "name_of_medicine": "Zerit", "ema_product_number": "EMEA/H/C/000110", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0107", "international_non_proprietary_name_common_name": "stavudine", "active_substance": "stavudine", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AF04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Hard capsules Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible. Powder for oral solution Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "13/02/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/05/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "11/08/2006", "last_updated_date": "13/10/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zerit" }, { "category": "Veterinary", "name_of_medicine": "Imrestor", "ema_product_number": "EMEA/V/C/002763", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pegbovigrastim", "active_substance": "pegbovigrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Colony stimulating factors;Immunostimulants;Antineoplastic agents", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/12/2015", "last_updated_date": "13/10/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/imrestor" }, { "category": "Human", "name_of_medicine": "Qtrilmet", "ema_product_number": "EMEA/H/C/004910", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0003", "international_non_proprietary_name_common_name": "metformin hydrochloride;saxagliptin;dapagliflozin", "active_substance": "metformin hydrochloride;saxagliptin;dapagliflozin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Qtrilmet is indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin with or without sulphonylurea (SU) and either saxagliptin or dapagliflozin does not provide adequate glycaemic control. when already being treated with metformin and saxagliptin and dapagliflozin.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "14/08/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/11/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "10/12/2019", "last_updated_date": "09/10/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qtrilmet" }, { "category": "Veterinary", "name_of_medicine": "CircoMax Myco", "ema_product_number": "EMEA/V/C/005184", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "porcine circovirus vaccine (inactivated, recombinant);mycoplasma hyopneumoniae vaccine (inactivated)", "active_substance": "Inactivated Mycoplasma hyopneumoniae, strain P-5722-3;inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2a open reading frame 2 (ORF2) protein;inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2b ORF2 protein", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated viral and inactivated bacterial vaccines", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/10/2020", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/circomax-myco" }, { "category": "Human", "name_of_medicine": "Sondelbay", "ema_product_number": "EMEA/H/C/005233", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "teriparatide", "active_substance": "teriparatide", "therapeutic_area_mesh": "Osteoporosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "19/06/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/06/2020", "last_updated_date": "28/09/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sondelbay-0" }, { "category": "Veterinary", "name_of_medicine": "Ecoporc Shiga", "ema_product_number": "EMEA/V/C/002588", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1256/G", "international_non_proprietary_name_common_name": "genetically modified Shiga-toxin-2e antigen", "active_substance": "genetically modified recombinant Shiga-toxin-2e antigen", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae;Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "15/09/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "07/02/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/04/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "20/04/2018", "last_updated_date": "18/09/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/ecoporc-shiga" }, { "category": "Human", "name_of_medicine": "Visudyne", "ema_product_number": "EMEA/H/C/000305", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0103", "international_non_proprietary_name_common_name": "verteporfin", "active_substance": "verteporfin", "therapeutic_area_mesh": "Myopia, Degenerative;Macular Degeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01LA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Visudyne is indicated for the treatment of: adults with exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV) or; adults with subfoveal choroidal neovascularisation secondary to pathological myopia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CHEPLAPHARM Arzneimittel GmbH", "european_commission_decision_date": "02/09/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/07/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "35", "first_published_date": "26/07/2018", "last_updated_date": "16/09/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/visudyne" }, { "category": "Human", "name_of_medicine": "Xiidra", "ema_product_number": "EMEA/H/C/004653", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "Lifitegrast", "therapeutic_area_mesh": "Dry Eye Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA25", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of moderate to severe dry eye disease in adults for whom prior artificial tears has not been sufficient", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "18/06/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/06/2020", "last_updated_date": "19/08/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xiidra" }, { "category": "Human", "name_of_medicine": "Duzallo", "ema_product_number": "EMEA/H/C/004412", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0002/G", "international_non_proprietary_name_common_name": "allopurinol;lesinurad", "active_substance": "allopurinol;lesinurad", "therapeutic_area_mesh": "Gout", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M04AA51", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antigout preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Grunenthal GmbH", "european_commission_decision_date": "31/07/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/06/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/08/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "06/08/2020", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duzallo" }, { "category": "Veterinary", "name_of_medicine": "Tulatrixx", "ema_product_number": "EMEA/V/C/005364", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tulathromycin", "active_substance": "tulathromycin", "therapeutic_area_mesh": "", "species_veterinary": "Cattle;Pigs;Sheep", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QJ01FA94", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "Cattle: Treatment and metaphylaxis of of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment. Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin. Pigs: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment. Draxxin should only be used if pigs are expected to develop the disease within 2-3 days. Sheep: Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Emdoka BVBA", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "01/04/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "04/08/2020", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/tulatrixx" }, { "category": "Human", "name_of_medicine": "Zurampic", "ema_product_number": "EMEA/H/C/003932", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0008", "international_non_proprietary_name_common_name": "lesinurad", "active_substance": "lesinurad", "therapeutic_area_mesh": "Hyperuricemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M04AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antigout preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Grünenthal GmbH", "european_commission_decision_date": "15/06/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/02/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "15/06/2017", "last_updated_date": "31/07/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zurampic" }, { "category": "Human", "name_of_medicine": "Picato", "ema_product_number": "EMEA/H/C/002275", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A-20/1489/C/002275/0030", "international_non_proprietary_name_common_name": "ingenol mebutate", "active_substance": "Ingenol mebutate", "therapeutic_area_mesh": "Keratosis, Actinic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D06BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibiotics and chemotherapeutics for dermatological use;Other chemotherapeutics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Picato is indicated for the cutaneous treatment of non?hyperkeratotic, non?hypertrophic actinic keratosis in adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "LEO Laboratories Ltd.", "european_commission_decision_date": "02/07/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "13/07/2017", "last_updated_date": "31/07/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/picato" }, { "category": "Human", "name_of_medicine": "Doxorubicin Hydrochloride Tillomed", "ema_product_number": "EMEA/H/C/005194", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "doxorubicin", "active_substance": "doxorubicin hydrochloride", "therapeutic_area_mesh": "Breast Neoplasms;Ovarian Neoplasms;Multiple Myeloma;Sarcoma, Kaposi", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01DB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi's sarcoma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratorios Tillomed Spain S.L.U", "european_commission_decision_date": "27/02/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "02/03/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/03/2020", "last_updated_date": "27/07/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/doxorubicin-hydrochloride-tillomed" }, { "category": "Human", "name_of_medicine": "Kolbam", "ema_product_number": "EMEA/H/C/002081", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0033", "international_non_proprietary_name_common_name": "cholic acid", "active_substance": "cholic acid", "therapeutic_area_mesh": "Metabolism, Inborn Errors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A05AA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bile and liver therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cholic Acid FGK is indicated for the treatment of inborn errors of primary bile acid synthesis, in infants from one month of age for continuous lifelong treatment through adulthood, encompassing the following single enzyme defects: sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency; 2- (or alpha-) methylacyl-CoA racemase (AMACR) deficiency; cholesterol 7 alpha-hydroxylase (CYP7A1) deficiency.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Retrophin Europe Ltd", "european_commission_decision_date": "27/03/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/11/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "07/12/2016", "last_updated_date": "15/07/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kolbam" }, { "category": "Human", "name_of_medicine": "Zemdri", "ema_product_number": "EMEA/H/C/004457", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "Plazomicin (sulfate)", "therapeutic_area_mesh": "Urinary Tract Infections;Pyelonephritis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cipla Europe NV", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "16/06/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/06/2020", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zemdri" }, { "category": "Human", "name_of_medicine": "Rituximab Mabion", "ema_product_number": "EMEA/H/C/005387", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rituximab", "active_substance": "rituximab", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell;Arthritis, Rheumatoid;Microscopic Polyangiitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Non-Hodgkin's lymphoma (NHL), Chronic lymphocytic leukaemia (CLL).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mabion Spolka Akcyjna", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "16/03/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/03/2020", "last_updated_date": "24/06/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rituximab-mabion" }, { "category": "Human", "name_of_medicine": "Fertavid", "ema_product_number": "EMEA/H/C/001042", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1702", "international_non_proprietary_name_common_name": "follitropin beta", "active_substance": "follitropin beta", "therapeutic_area_mesh": "Infertility;Hypogonadism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03GA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "In the female: Fertavid is indicated for the treatment of female infertility in the following clinical situations: Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomifene citrate Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "20/01/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/03/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "07/07/2018", "last_updated_date": "23/06/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fertavid" }, { "category": "Human", "name_of_medicine": "Fingolimod Mylan", "ema_product_number": "EMEA/H/C/005282", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fingolimod", "active_substance": "fingolimod hydrochloride ", "therapeutic_area_mesh": "Multiple Sclerosis, Relapsing-Remitting", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan Ireland Limited", "european_commission_decision_date": "28/04/2023", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "08/05/2020", "marketing_authorisation_date": "18/08/2021", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/05/2020", "last_updated_date": "17/06/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fingolimod-mylan-0" }, { "category": "Human", "name_of_medicine": "Helixate NexGen", "ema_product_number": "EMEA/H/C/000276", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A31/0178", "international_non_proprietary_name_common_name": "octocog alfa", "active_substance": "octocog alfa", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG ", "european_commission_decision_date": "16/11/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/08/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "31", "first_published_date": "16/11/2017", "last_updated_date": "02/06/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/helixate-nexgen" }, { "category": "Human", "name_of_medicine": "Erlotinib Accord", "ema_product_number": "EMEA/H/C/005071", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "erlotinib", "active_substance": "", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Pancreatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of lung and pancreatic cancers", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare S.L.U.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "28/05/2020", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/05/2020", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/erlotinib-accord" }, { "category": "Human", "name_of_medicine": "Osseor", "ema_product_number": "EMEA/H/C/000561", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "SW/0045", "international_non_proprietary_name_common_name": "strontium ranelate", "active_substance": "strontium ranelate", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of severe osteoporosis in postmenopausal women at high risk for fracture to reduce the risk of vertebral and hip fractures. Treatment of severe osteoporosis in adult men at increased risk of fracture. The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "22/05/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "15/09/2016", "last_updated_date": "19/05/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/osseor" }, { "category": "Human", "name_of_medicine": "Vynpenta (previously AvacopanChemoCentryx)", "ema_product_number": "EMEA/H/C/004487", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "avacopan", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Induction of response in adult patients with granulomatosis with polyangiitis (Wegener’s) (GPA) or microscopic polyangiitis (MPA)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ChemoCentryx Ltd", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "23/01/2019", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/02/2019", "last_updated_date": "15/05/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vynpenta" }, { "category": "Human", "name_of_medicine": "Protelos", "ema_product_number": "EMEA/H/C/000560", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "SW/0050", "international_non_proprietary_name_common_name": "strontium ranelate", "active_substance": "strontium ranelate", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of severe osteoporosis in postmenopausal women at high risk for fracture to reduce the risk of vertebral and hip fractures. Treatment of severe osteoporosis in adult men at increased risk of fracture. The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "22/05/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "15/09/2016", "last_updated_date": "15/05/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/protelos" }, { "category": "Veterinary", "name_of_medicine": "Suvaxyn PCV", "ema_product_number": "EMEA/V/C/000149", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0028", "international_non_proprietary_name_common_name": "adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets", "active_substance": "porcine circovirus recombinant virus (CPCV) 1-2, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "Pigs (piglets)", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI09AA07", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "Active immunisation of pigs over the age of three weeks against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with post-weaning multisystemic wasting syndrome.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zoetis Belgium SA", "european_commission_decision_date": "08/04/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "23/03/2017", "last_updated_date": "15/04/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/suvaxyn-pcv" }, { "category": "Veterinary", "name_of_medicine": "Zulvac 1 Ovis", "ema_product_number": "EMEA/V/C/002335", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/00017", "international_non_proprietary_name_common_name": "inactivated bluetongue virus, serotype-1", "active_substance": "inactivated bluetongue virus, serotype-1", "therapeutic_area_mesh": "", "species_veterinary": "Sheep", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI04AA02", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "Active immunisation of sheep from 1.5 months of age for the prevention of viraemia caused by bluetongue virus, serotypes-1. Onset of immunity: 21 days after completion of the primary vaccination scheme. Duration of immunity: 12 months.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zoetis Belgium SA", "european_commission_decision_date": "21/06/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/08/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "23/03/2017", "last_updated_date": "01/04/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zulvac-1-ovis" }, { "category": "Veterinary", "name_of_medicine": "Zulvac 1 Bovis", "ema_product_number": "EMEA/V/C/002334", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/00017", "international_non_proprietary_name_common_name": "inactivated bluetongue virus, serotype 1", "active_substance": "inactivated bluetongue virus, serotype 1", "therapeutic_area_mesh": "", "species_veterinary": "Cattle", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI02AA08", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "Active immunisation of cattle from 2½ months of age for the prevention of viraemia caused by bluetongue virus, serotype 1. Onset of immunity: 15 days after completion of the primary vaccination course. Duration of immunity: 12 months.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zoetis Belgium SA", "european_commission_decision_date": "21/06/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/08/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "23/03/2017", "last_updated_date": "30/03/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zulvac-1-bovis" }, { "category": "Human", "name_of_medicine": "Kromeya", "ema_product_number": "EMEA/H/C/005158", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1651", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Psoriasis;Arthritis, Psoriatic;Spondylitis, Ankylosing;Uveitis;Colitis, Ulcerative;Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis Kromeya in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Kromeya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Kromeya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Kromeya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Kromeya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Kromeya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Kromeya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Kromeya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Kromeya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Crohn’s disease Kromeya is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Kromeya is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Kromeya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Kromeya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. Paediatric Uveitis Kromeya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fresenius Kabi Deutschland GmbH", "european_commission_decision_date": "03/10/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/01/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/04/2019", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "26/04/2019", "last_updated_date": "25/03/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kromeya" }, { "category": "Human", "name_of_medicine": "Clopidogrel BGR (previously Zylagren)", "ema_product_number": "EMEA/H/C/001138", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0040", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrogen sulfate)", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biogaran", "european_commission_decision_date": "24/02/2020", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "17", "first_published_date": "19/07/2017", "last_updated_date": "11/03/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-bgr" }, { "category": "Human", "name_of_medicine": "Ekesivy", "ema_product_number": "EMEA/H/C/005141", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "diclofenamide", "therapeutic_area_mesh": "Paralyses, Familial Periodic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01EC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of periodic paralysis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "02/10/2019", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/10/2019", "last_updated_date": "06/03/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ekesivy" }, { "category": "Human", "name_of_medicine": "Xiapex", "ema_product_number": "EMEA/H/C/002048", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00000871/201902", "international_non_proprietary_name_common_name": "collagenase Clostridium histolyticum", "active_substance": "collagenase Clostridium histolyticum", "therapeutic_area_mesh": "Dupuytren Contracture", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "The treatment of Dupuytren’s contracture in adult patients with a palpable cord. The treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Swedish Orphan Biovitrum AB", "european_commission_decision_date": "28/11/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/02/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "08/12/2017", "last_updated_date": "02/03/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xiapex" }, { "category": "Human", "name_of_medicine": "Varuby", "ema_product_number": "EMEA/H/C/004196", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0015", "international_non_proprietary_name_common_name": "rolapitant", "active_substance": "rolapitant", "therapeutic_area_mesh": "Vomiting;Nausea;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A04AD", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiemetics and antinauseants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.Varuby is given as part of combination therapy.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "TESARO Bio Netherlands B.V.", "european_commission_decision_date": "11/03/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/02/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "02/10/2017", "last_updated_date": "02/03/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/varuby" }, { "category": "Human", "name_of_medicine": "Lifmior", "ema_product_number": "EMEA/H/C/004167", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1082", "international_non_proprietary_name_common_name": "etanercept", "active_substance": "etanercept", "therapeutic_area_mesh": "Arthritis, Psoriatic;Spondylitis, Ankylosing;Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritis; Juvenile idiopathic arthritis Psoriatic arthritis; Axial spondyloarthritis; Plaque psoriasis; Paediatric plaque psoriasis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "05/04/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/02/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "16/02/2020", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "23/08/2018", "last_updated_date": "20/02/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lifmior" }, { "category": "Human", "name_of_medicine": "Iblias", "ema_product_number": "EMEA/H/C/004147", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A31/0002", "international_non_proprietary_name_common_name": "octocog alfa", "active_substance": "octocog alfa", "therapeutic_area_mesh": "Hemophilia A", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Iblias can be used for all age groups.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer AG", "european_commission_decision_date": "10/11/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/02/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "10/11/2017", "last_updated_date": "18/02/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/iblias" }, { "category": "Human", "name_of_medicine": "Nonafact", "ema_product_number": "EMEA/H/C/000348", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0062", "international_non_proprietary_name_common_name": "human coagulation factor IX", "active_substance": "human coagulation factor IX", "therapeutic_area_mesh": "Hemophilia B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanquin Plasma Products B.V.", "european_commission_decision_date": "24/11/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/07/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "24/11/2016", "last_updated_date": "18/02/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nonafact" }, { "category": "Human", "name_of_medicine": "Luxceptar", "ema_product_number": "EMEA/H/C/002397", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Graft vs Host Disease;Hematopoietic Stem Cell Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adjunctive treatment in haematopoietic stem cell transplantation (HSCT) for a malignant disease", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Kiadis Pharma Netherlands B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "06/11/2019", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/11/2019", "last_updated_date": "17/02/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/luxceptar" }, { "category": "Human", "name_of_medicine": "Zalmoxis", "ema_product_number": "EMEA/H/C/002801", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0009/G", "international_non_proprietary_name_common_name": "allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)", "active_substance": "allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation;Graft vs Host Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "MolMed SpA", "european_commission_decision_date": "26/07/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "26/07/2018", "last_updated_date": "14/02/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zalmoxis" }, { "category": "Human", "name_of_medicine": "Xyndari", "ema_product_number": "EMEA/H/C/004734", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Anemia, Sickle Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of sickle cell disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Emmaus Medical Europe Ltd", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "18/09/2019", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/10/2019", "last_updated_date": "11/02/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xyndari" }, { "category": "Human", "name_of_medicine": "Idhifa", "ema_product_number": "EMEA/H/C/004324", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of acute myeloid leukaemia (AML)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celgene Europe BV", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "06/12/2019", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/01/2020", "last_updated_date": "07/02/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/idhifa" }, { "category": "Human", "name_of_medicine": "Nuzyra", "ema_product_number": "EMEA/H/C/004715", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Pneumonia, Bacterial;Skin Diseases, Bacterial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01AA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Paratek Ireland Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/10/2019", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/10/2019", "last_updated_date": "05/02/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nuzyra" }, { "category": "Human", "name_of_medicine": "Fexeric", "ema_product_number": "EMEA/H/C/003776", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0015", "international_non_proprietary_name_common_name": "ferric citrate coordination complex", "active_substance": "ferric citrate coordination complex", "therapeutic_area_mesh": "Hyperphosphatemia;Renal Dialysis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Akebia Europe Limited", "european_commission_decision_date": "09/09/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/09/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/01/2020", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "12/10/2016", "last_updated_date": "04/02/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fexeric" }, { "category": "Human", "name_of_medicine": "Linhaliq", "ema_product_number": "EMEA/H/C/004394", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Bronchiectasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01MA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infection with Pseudomonas aeruginosa (P. aeruginosa)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Aradigm Pharmaceuticals Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "29/10/2019", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/11/2019", "last_updated_date": "24/01/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/linhaliq" }, { "category": "Human", "name_of_medicine": "Aerivio Spiromax", "ema_product_number": "EMEA/H/C/002752", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0003", "international_non_proprietary_name_common_name": "salmeterol;fluticasone propionate", "active_substance": "salmeterol xinafoate;fluticasone propionate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive;Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aerivio Spiromax is indicated for use in adults aged 18 years and older only. Asthma Aerivio Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting ?2 agonist) is appropriate: patients not adequately controlled on a lower strength corticosteroid combination product or patients already controlled on a high dose inhaled corticosteroid and long-acting ?2 agonist. Chronic Obstructive Pulmonary Disease (COPD) Aerivio Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "04/10/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "04/10/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "09/06/2017", "last_updated_date": "15/01/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aerivio-spiromax" }, { "category": "Human", "name_of_medicine": "Vanflyta", "ema_product_number": "EMEA/H/C/004468", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "quizartinib", "active_substance": "quizartinib dihydrochloride", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of acute myeloid leukaemia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Daiichi Sankyo Europe GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/10/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "19/12/2019", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/01/2020", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vanflyta-0" }, { "category": "Human", "name_of_medicine": "Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)", "ema_product_number": "EMEA/H/C/001144", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1665", "international_non_proprietary_name_common_name": "clopidogrel;acetylsalicylic acid", "active_substance": "clopidogrel;acetylsalicylic acid", "therapeutic_area_mesh": "Acute Coronary Syndrome;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC30", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Acute Coronary Syndrome Myocardial Infarction", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi-Aventis Groupe", "european_commission_decision_date": "19/09/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/03/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "18/01/2018", "last_updated_date": "13/11/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-zentiva" }, { "category": "Human", "name_of_medicine": "Thorinane", "ema_product_number": "EMEA/H/C/003795", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0003", "international_non_proprietary_name_common_name": "enoxaparin sodium", "active_substance": "enoxaparin sodium", "therapeutic_area_mesh": "Venous Thromboembolism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Thorinane is indicated for adults for: - Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery. - Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL). - Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism. - Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA). - Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL). - Blood clot prevention in the extracorporeal circulation during haemodialysis. Prevention and treatment of various disorders related to blood clots in adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharmathen S.A.", "european_commission_decision_date": "05/09/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/07/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/09/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/09/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "05/09/2017", "last_updated_date": "24/10/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/thorinane" }, { "category": "Human", "name_of_medicine": "Imatinib medac", "ema_product_number": "EMEA/H/C/002692", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0009", "international_non_proprietary_name_common_name": "imatinib", "active_substance": "imatinib", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma;Dermatofibrosarcoma;Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Myelodysplastic-Myeloproliferative Diseases;Hypereosinophilic Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imatinib medac is indicated for the treatment of: paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment; paediatric patients with Ph+CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase; adult and paediatric patients with Ph+CML in blast crisis; adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) integrated with chemotherapy; adult patients with relapsed or refractory Ph+ALL as monotherapy; adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements; adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR? rearrangement; adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. The effect of imatinib on the outcome of bone marrow transplantation has not been determined. In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Medac", "european_commission_decision_date": "11/04/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "14/02/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "11/04/2018", "last_updated_date": "16/10/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imatinib-medac" }, { "category": "Human", "name_of_medicine": "Taxespira (previously Docetaxel Hospira UK Limited )", "ema_product_number": "EMEA/H/C/003925", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0011", "international_non_proprietary_name_common_name": "docetaxel", "active_substance": "docetaxel trihydrate", "therapeutic_area_mesh": "Stomach Neoplasms;Prostatic Neoplasms;Breast Neoplasms;Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxespira in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small cell lung cancer Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Taxespira in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Hospira UK Limited", "european_commission_decision_date": "30/10/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/05/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/08/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "30/10/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "09/07/2018", "last_updated_date": "15/10/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/taxespira" }, { "category": "Veterinary", "name_of_medicine": "Horse Allo 20", "ema_product_number": "EMEA/V/C/004328", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "allogeneic equine adipose-derived mesenchymal stem cells", "active_substance": "allogeneic equine adipose-derived mesenchymal stem cells", "therapeutic_area_mesh": "", "species_veterinary": "Horses", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the treatment osteoarthritis in adult non-food producing horses.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Centauri Biotech SL", "european_commission_decision_date": "22/06/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/06/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "13/05/2019", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/09/2019", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/horse-allo-20" }, { "category": "Human", "name_of_medicine": "Lartruvo", "ema_product_number": "EMEA/H/C/004216", "medicine_status": "Revoked", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010541/201704", "international_non_proprietary_name_common_name": "olaratumab", "active_substance": "olaratumab", "therapeutic_area_mesh": "Sarcoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin (see section 5.1).", "accelerated_assessment": "Yes", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "11/01/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/09/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/07/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "11/01/2018", "last_updated_date": "02/09/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lartruvo" }, { "category": "Human", "name_of_medicine": "Daklinza", "ema_product_number": "EMEA/H/C/003768", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0034", "international_non_proprietary_name_common_name": "daclatasvir", "active_substance": "daclatasvir dihydrochloride", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AP07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1). For HCV genotype specific activity, see sections 4.4 and 5.1.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "24/07/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/06/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "26/08/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "14/06/2018", "last_updated_date": "30/08/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/daklinza" }, { "category": "Human", "name_of_medicine": "Doxolipad", "ema_product_number": "EMEA/H/C/004110", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "doxorubicin", "active_substance": "doxorubicin hydrochloride", "therapeutic_area_mesh": "Breast Neoplasms;Ovarian Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01DB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of breast and ovarian cancer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "TLC Biopharmaceuticals B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "29/05/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "08/08/2019", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/08/2019", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/doxolipad" }, { "category": "Human", "name_of_medicine": "Radicava", "ema_product_number": "EMEA/H/C/004938", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "edaravone", "therapeutic_area_mesh": "Amyotrophic Lateral Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of amyotrophic lateral sclerosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mitsubishi Tanabe Pharma GmbH", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "24/05/2019", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/05/2019", "last_updated_date": "14/08/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/radicava" }, { "category": "Veterinary", "name_of_medicine": "Bovalto Ibraxion", "ema_product_number": "EMEA/V/C/000051", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0016", "international_non_proprietary_name_common_name": "infectious bovine rhinotracheitis vaccine (inactivated)", "active_substance": "inactivated IBR virus", "therapeutic_area_mesh": "", "species_veterinary": "Cattle", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI02AA03", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Bovidae", "therapeutic_indication": "Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.The onset of immunity is 14 days and the duration of immunity is 6 months.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merial", "european_commission_decision_date": "10/08/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/03/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "10/08/2016", "last_updated_date": "13/08/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bovalto-ibraxion" }, { "category": "Human", "name_of_medicine": "Cabazitaxel Teva", "ema_product_number": "EMEA/H/C/004951", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "cabazitaxel", "active_substance": "cabazitaxel", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of prostate cancer", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/04/2019", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "11/07/2019", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/04/2019", "last_updated_date": "24/07/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cabazitaxel-teva" }, { "category": "Human", "name_of_medicine": "Rituzena (previously Tuxella)", "ema_product_number": "EMEA/H/C/004724", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/1053/G", "international_non_proprietary_name_common_name": "rituximab", "active_substance": "rituximab", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin;Microscopic Polyangiitis;Leukemia, Lymphocytic, Chronic, B-Cell;Wegener Granulomatosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rituzena is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Rituzena is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy. Rituzena monotherapy is indicated for treatment of patients with stage III IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy. Rituzena is indicated for the treatment of patients with CD20 positive diffuse large B cell non Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Chronic lymphocytic leukaemia (CLL) Rituzena in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Rituzenaor patients refractory to previous Rituzena plus chemotherapy. Granulomatosis with polyangiitis and microscopic polyangiitis Rituzena, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celltrion Healthcare Hungary Kft.", "european_commission_decision_date": "28/01/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/05/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/07/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "10/04/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "19/07/2018", "last_updated_date": "08/07/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rituzena" }, { "category": "Human", "name_of_medicine": "ATryn", "ema_product_number": "EMEA/H/C/000587", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0038", "international_non_proprietary_name_common_name": "antithrombin alfa", "active_substance": "antithrombin alfa", "therapeutic_area_mesh": "Antithrombin III Deficiency", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. ATryn is normally given in association with heparin or low molecular weight heparin.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoire Francais du Fractionnement et des Biotechnologies", "european_commission_decision_date": "22/12/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/07/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/12/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "19/07/2018", "last_updated_date": "02/07/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/atryn" }, { "category": "Human", "name_of_medicine": "Airexar Spiromax", "ema_product_number": "EMEA/H/C/004267", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0003", "international_non_proprietary_name_common_name": "salmeterol xinafoate;fluticasone propionate", "active_substance": "salmeterol;fluticasone propionate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive;Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Airexar Spiromax is indicated for use in adults aged 18 years and older only. AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting ?2 agonist) is appropriate: - patients not adequately controlled on a lower strength corticosteroid combination product or - patients already controlled on a high dose inhaled corticosteroid and long-acting ?2 agonist. Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "19/02/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/06/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/08/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/04/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "09/03/2017", "last_updated_date": "02/07/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/airexar-spiromax" }, { "category": "Human", "name_of_medicine": "ABP 710", "ema_product_number": "EMEA/H/C/005020", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "infliximab", "active_substance": "infliximab", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, psoriasis and ulcerative colitis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "27/05/2019", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/06/2019", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abp-710" }, { "category": "Veterinary", "name_of_medicine": "Ingelvac PCV FLEX", "ema_product_number": "EMEA/V/C/004645", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/0855/G", "international_non_proprietary_name_common_name": "porcine circovirus vaccine (inactivated)", "active_substance": "porcine circovirus type 2 ORF2 protein", "therapeutic_area_mesh": "", "species_veterinary": "Pigs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI09AA07", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae", "therapeutic_indication": "For active immunisation of pigs with no PCV2 maternally derived antibodies from the age of 2 weeks against porcine circovirus type 2 (PCV2)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim Vetmedica GmbH", "european_commission_decision_date": "24/11/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "16/03/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/05/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "24/11/2017", "last_updated_date": "28/06/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/ingelvac-pcv-flex" }, { "category": "Human", "name_of_medicine": "Ketek", "ema_product_number": "EMEA/H/C/000354", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0068", "international_non_proprietary_name_common_name": "telithromycin", "active_substance": "telithromycin", "therapeutic_area_mesh": "Sinusitis;Tonsillitis;Bronchitis, Chronic;Pharyngitis;Community-Acquired Infections;Pneumonia, Bacterial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01FA15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "When prescribing Ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agents and the local prevalence of resistance. Ketek is indicated for the treatment of the following infections: In patients of 18 years and older community-acquired pneumonia, mild or moderate. when treating infections caused by known or suspected beta-lactam- and / or macrolide-resistant strains (according to history of patients or national and / or regional resistance data) covered by the antibacterial spectrum of telithromycin: acute exacerbation of chronic bronchitis; acute sinusitis; In patients of 12 years and older tonsillitis / pharyngitis caused by Streptococcus pyogenes, as an alternative when beta-lactam antibiotics are not appropriate in countries / regions with a significant prevalence of macrolide-resistant S. pyogenes, when mediated by ermTR or mefA.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Aventis Pharma S.A.", "european_commission_decision_date": "07/02/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/07/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "07/06/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "07/02/2017", "last_updated_date": "19/06/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ketek" }, { "category": "Human", "name_of_medicine": "Ambrisentan Zentiva", "ema_product_number": "EMEA/H/C/004955", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ambrisentan", "active_substance": "ambrisentan", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of pulmonary arterial hypertension.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zentiva, k.s.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "29/04/2019", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/05/2019", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ambrisentan-zentiva" }, { "category": "Human", "name_of_medicine": "Arzerra", "ema_product_number": "EMEA/H/C/001131", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0051", "international_non_proprietary_name_common_name": "ofatumumab", "active_substance": "ofatumumab", "therapeutic_area_mesh": "Leukemia, Lymphocytic, Chronic, B-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Monoclonal antibodies", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Previously untreated chronic lymphocytic leukaemia (CLL): Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Relapsed CLL: Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL. Refractory CLL: Arzerra is indicated for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd", "european_commission_decision_date": "02/10/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/04/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/02/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "02/10/2017", "last_updated_date": "10/05/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/arzerra" }, { "category": "Human", "name_of_medicine": "Canakinumab Novartis", "ema_product_number": "EMEA/H/C/004754", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "canakinumab", "active_substance": "canakinumab", "therapeutic_area_mesh": "Acute Coronary Syndrome;Myocardial Infarction;Stroke", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of major cardiovascular events", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "04/12/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/12/2018", "last_updated_date": "07/05/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/canakinumab-novartis" }, { "category": "Veterinary", "name_of_medicine": "Parvoduk", "ema_product_number": "EMEA/V/C/002740", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0006", "international_non_proprietary_name_common_name": "live attenuated Muscovy duck parvovirus", "active_substance": "live attenuated Muscovy duck parvovirus", "therapeutic_area_mesh": "", "species_veterinary": "Ducks", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI01BD03", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "duck parvovirus;Live viral vaccines;Immunologicals for aves", "therapeutic_indication": "Active immunisation of ducks to prevent mortality1 and to reduce weight loss and lesions of duck parvovirosis and Derzsy's disease. 1In absence of maternally derived antibodies.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merial", "european_commission_decision_date": "09/01/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/04/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/04/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "04/12/2015", "last_updated_date": "15/04/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/parvoduk" }, { "category": "Human", "name_of_medicine": "Efgratin", "ema_product_number": "EMEA/H/C/004789", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neutropenia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/12/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/02/2019", "last_updated_date": "05/04/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/efgratin-0" }, { "category": "Human", "name_of_medicine": "Cavoley", "ema_product_number": "EMEA/H/C/005008", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neutropenia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Stada Arzneimittel AG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/12/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/02/2019", "last_updated_date": "05/04/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cavoley-0" }, { "category": "Human", "name_of_medicine": "Silgard", "ema_product_number": "EMEA/H/C/000732", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/1349/G", "international_non_proprietary_name_common_name": "human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)", "active_substance": "human papillomavirus type 6 L1 protein;human papillomavirus type 11 L1 protein;human papillomavirus type 16 L1 protein;human papillomavirus type 18 L1 protein", "therapeutic_area_mesh": "Papillomavirus Infections;Uterine Cervical Dysplasia;Condylomata Acuminata;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BM01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Silgard is a vaccine for use from the age of 9 years for the prevention of: premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types; genital warts (condyloma acuminata) causally related to specific HPV types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Silgard should be in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp Dohme Ltd", "european_commission_decision_date": "18/02/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/02/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "33", "first_published_date": "17/05/2018", "last_updated_date": "02/04/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/silgard" }, { "category": "Veterinary", "name_of_medicine": "Equitend", "ema_product_number": "EMEA/V/C/002774", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "Horses", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "OTR3", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "05/11/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/04/2019", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/equitend" }, { "category": "Human", "name_of_medicine": "Vantobra", "ema_product_number": "EMEA/H/C/002633", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0010", "international_non_proprietary_name_common_name": "tobramycin", "active_substance": "tobramycin", "therapeutic_area_mesh": "Cystic Fibrosis;Respiratory Tract Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01GB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use;Aminoglycoside antibacterials", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF). Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pari Pharma GmbH", "european_commission_decision_date": "21/09/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/03/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/02/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "21/09/2017", "last_updated_date": "29/03/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vantobra" }, { "category": "Veterinary", "name_of_medicine": "Longrange", "ema_product_number": "EMEA/V/C/004291", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "eprinomectin", "active_substance": "eprinomectin", "therapeutic_area_mesh": "", "species_veterinary": "Cattle", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QP54AA04", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Endectocides", "therapeutic_indication": "Treatment of the following parasites: Gastrointestinal Roundworms (Adult and L4): - Ostertagia ostertagi/lyrata, Cooperia oncophora/surnabada, C. punctata, Haemonchus contortus, Trichostrongylus axei, T. colubriformis, Bunostomum phlebotomum, Nematodirus helvetianus, Oesophagostomum radiatum Lungworm (Adults and L4): - Dictyocaulus viviparus Warbles (parasitic stages): - Hypoderma bovis, H. lineatum Mange mites: - Sarcoptes scabiei var. Bovis Lice: Linognathus vituli, Haematopinus eurysternus, Solenoptes capillatus Horn flies: Haematobia irritans Prevention of reinfections with the following parasites: - Dictyocaulus viviparus, Ostertagia ostertagi/lyrata, Trichostrongylus colubriformis, Haemonchus contortus, and Bunostomum phlebotomum; - Oesophagostomum radiatum, Cooperia oncophora/surnabada, C. punctata and Trichostrongylus axei.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merial", "european_commission_decision_date": "12/12/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/06/2018", "last_updated_date": "21/03/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/longrange" }, { "category": "Human", "name_of_medicine": "Altargo", "ema_product_number": "EMEA/H/C/000757", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0030", "international_non_proprietary_name_common_name": "retapamulin", "active_substance": "retapamulin", "therapeutic_area_mesh": "Impetigo;Staphylococcal Skin Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D06AX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibiotics and chemotherapeutics for dermatological use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Short term treatment of the following superficial skin infections: impetigo; infected small lacerations, abrasions or sutured wounds. See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Glaxo Group Ltd", "european_commission_decision_date": "09/11/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/05/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "25/02/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "09/11/2015", "last_updated_date": "15/03/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/altargo" }, { "category": "Human", "name_of_medicine": "Topotecan Actavis", "ema_product_number": "EMEA/H/C/001031", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0013", "international_non_proprietary_name_common_name": "topotecan", "active_substance": "topotecan", "therapeutic_area_mesh": "Uterine Cervical Neoplasms;Small Cell Lung Carcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Actavis Group PTC ehf", "european_commission_decision_date": "15/01/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/01/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "19/01/2014", "last_updated_date": "07/03/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/topotecan-actavis" }, { "category": "Human", "name_of_medicine": "Cyltezo", "ema_product_number": "EMEA/H/C/004319", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0005/G", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Hidradenitis Suppurativa;Arthritis, Psoriatic;Psoriasis;Crohn Disease;Arthritis, Juvenile Rheumatoid;Uveitis;Arthritis, Rheumatoid;Colitis, Ulcerative;Spondylitis, Ankylosing", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Please refer to section 4.1 of the Summary of product characteristics in the product information document.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "15/01/2019", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/01/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "19/02/2018", "last_updated_date": "06/03/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cyltezo" }, { "category": "Human", "name_of_medicine": "Solymbic", "ema_product_number": "EMEA/H/C/004373", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/0946", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Arthritis, Psoriatic;Spondylitis, Ankylosing;Crohn Disease;Colitis, Ulcerative;Hidradenitis Suppurativa;Psoriasis;Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Please refer to section 4.1 of the Summary of product characteristics in the product information document.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "22/06/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/12/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/03/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/06/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "14/06/2018", "last_updated_date": "05/03/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/solymbic" }, { "category": "Human", "name_of_medicine": "Epjevy", "ema_product_number": "EMEA/H/C/004793", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Primary Myelofibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of disease-related splenomegaly and control of symptoms in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have thrombocytopenia (platelet counts ?100,000 /?L).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CTI Life Sciences Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "07/02/2019", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/03/2019", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/epjevy" }, { "category": "Human", "name_of_medicine": "Eperzan", "ema_product_number": "EMEA/H/C/002735", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0031", "international_non_proprietary_name_common_name": "albiglutide", "active_substance": "albiglutide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BJ04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance. Add-on combination therapy In combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Trading Services Limited", "european_commission_decision_date": "14/09/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/01/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/03/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "29/10/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "14/09/2017", "last_updated_date": "20/02/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eperzan" }, { "category": "Human", "name_of_medicine": "Eladynos", "ema_product_number": "EMEA/H/C/004157", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "abaloparatide", "active_substance": "abaloparatide", "therapeutic_area_mesh": "Osteoporosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Radius Health Ireland Ltd", "european_commission_decision_date": "03/04/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "07/01/2019", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "03/04/2018", "last_updated_date": "14/02/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eladynos-0" }, { "category": "Human", "name_of_medicine": "Graspa", "ema_product_number": "EMEA/H/C/004736", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "asparaginase", "active_substance": "asparaginase", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "LX1XX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of acute lymphoblastic leukaemia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ERYTECH Pharma S.A.", "european_commission_decision_date": "29/06/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "22/06/2018", "marketing_authorisation_date": "27/06/2018", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/06/2018", "last_updated_date": "23/01/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/graspa-0" }, { "category": "Human", "name_of_medicine": "Lusduna", "ema_product_number": "EMEA/H/C/004101", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0006", "international_non_proprietary_name_common_name": "insulin glargine", "active_substance": "insulin glargine", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp & Dohme B.V.", "european_commission_decision_date": "29/10/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/01/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "29/10/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "15/06/2018", "last_updated_date": "22/01/2019", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lusduna" }, { "category": "Human", "name_of_medicine": "Ivabradine JensonR", "ema_product_number": "EMEA/H/C/004217", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "ivabradine", "active_substance": "ivabradine hydrochloride", "therapeutic_area_mesh": "Angina Pectoris;Heart Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01EB17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "JensonR+ Limited", "european_commission_decision_date": "11/11/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/06/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/11/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "06/12/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/11/2016", "last_updated_date": "20/12/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ivabradine-jensonr" }, { "category": "Human", "name_of_medicine": "Fyzoclad", "ema_product_number": "EMEA/H/C/005253", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Psoriasis;Arthritis, Psoriatic;Spondylitis, Ankylosing;Uveitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of juvenile idiopathic arthritis, paediatric plaque psoriasis, paediatric uveitis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Europe MA EEIG", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "05/12/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/12/2018", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fyzoclad" }, { "category": "Human", "name_of_medicine": "Entolimod TMC", "ema_product_number": "EMEA/H/C/004656", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "Entolimod", "therapeutic_area_mesh": "Acute Radiation Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03A", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of acute radiation syndrome", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "TMC Pharma Services Ltd", "european_commission_decision_date": "20/09/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "31/07/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/09/2018", "last_updated_date": "12/12/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/entolimod-tmc" }, { "category": "Human", "name_of_medicine": "Exondys", "ema_product_number": "EMEA/H/C/004355", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "eteplirsen", "active_substance": "eteplirsen", "therapeutic_area_mesh": "Muscular Dystrophy, Duchenne", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Duchenne muscular dystrophy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AVI Biopharma International Ltd", "european_commission_decision_date": "01/06/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/09/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "06/12/2018", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/12/2018", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exondys" }, { "category": "Human", "name_of_medicine": "Zoledronic acid Teva Pharma", "ema_product_number": "EMEA/H/C/002437", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0014", "international_non_proprietary_name_common_name": "zoledronic acid", "active_substance": "zoledronic acid", "therapeutic_area_mesh": "Osteoporosis;Osteitis Deformans;Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: in post-menopausal women; in men; at increased risk of fracture. Treatment of Paget’s disease of the bone in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "18/01/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/08/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/01/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "22/05/2017", "last_updated_date": "12/12/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zoledronic-acid-teva-pharma" }, { "category": "Veterinary", "name_of_medicine": "Zydax", "ema_product_number": "EMEA/V/C/004375", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QM09AX", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Other drugs for disorders of the musculo-skeletal system", "therapeutic_indication": "For the treatment of lameness, pain and mobility impairment of osteoarthritis (non-infectious arthrosis) and related musculoskeletal disorders by therapeutic activity on the underlying pathological processes (disease modifying osteoarthritis drug) in dogs.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Parnell Technologies (UK) Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "03/12/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "03/12/2018", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zydax" }, { "category": "Veterinary", "name_of_medicine": "HopGuard Gold", "ema_product_number": "EMEA/V/C/002836", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "Honey bees", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QP53AX", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of varroosis due to Varroa destructor.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vita (Europe) Limited", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "12/04/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/11/2018", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/hopguard-gold" }, { "category": "Human", "name_of_medicine": "Trobalt", "ema_product_number": "EMEA/H/C/001245", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0043", "international_non_proprietary_name_common_name": "retigabine", "active_substance": "retigabine", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trobalt is indicated as adjunctive treatment of drug-resistant partial-onset seizures with or without secondary generalisation in patients aged 18 years or older with epilepsy, where other appropriate drug combinations have proved inadequate or have not been tolerated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Glaxo Group Limited ", "european_commission_decision_date": "19/07/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/03/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "19/07/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "11/05/2016", "last_updated_date": "19/11/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trobalt" }, { "category": "Veterinary", "name_of_medicine": "BTVPUR AlSap 2-4", "ema_product_number": "EMEA/V/C/000139", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0006", "international_non_proprietary_name_common_name": "inactivated adjuvanted vaccine against bluetongue virus serotype 2 and 4 infections", "active_substance": "bluetongue-virus serotype-2 antigen;bluetongue-virus serotype-4 antigen", "therapeutic_area_mesh": "", "species_veterinary": "Sheep", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI04AA02", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "bluetongue virus;Inactivated viral vaccines;Immunologicals for Ovidae", "therapeutic_indication": "Active immunisation of sheep to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 2 and 4.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mérial", "european_commission_decision_date": "01/06/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/11/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "31/07/2015", "last_updated_date": "13/11/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/btvpur-alsap-2-4" }, { "category": "Human", "name_of_medicine": "Ionsys", "ema_product_number": "EMEA/H/C/002715", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "--", "international_non_proprietary_name_common_name": "fentanyl", "active_substance": "fentanyl hydrochloride", "therapeutic_area_mesh": "Pain, Postoperative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02AB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Incline Therapeutics Europe Ltd", "european_commission_decision_date": "26/10/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/09/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "19/11/2015", "last_updated_date": "06/11/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ionsys" }, { "category": "Human", "name_of_medicine": "Raplixa", "ema_product_number": "EMEA/H/C/002807", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0021/G", "international_non_proprietary_name_common_name": "human fibrinogen;human thrombin", "active_substance": "human fibrinogen;human thrombin", "therapeutic_area_mesh": "Hemostasis, Surgical", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BC30", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis. Raplixa must be used in combination with an approved gelatin sponge. Raplixa is indicated in adults over 18 years of age.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mallinckrodt Pharmaceuticals Ireland Limited", "european_commission_decision_date": "19/03/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/03/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "19/03/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "06/04/2017", "last_updated_date": "10/10/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/raplixa" }, { "category": "Human", "name_of_medicine": "Imatinib Teva B.V.", "ema_product_number": "EMEA/H/C/004748", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "imatinib", "active_substance": "imatinib mesilate", "therapeutic_area_mesh": "Dermatofibrosarcoma;Gastrointestinal Stromal Tumors;Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imatinib Teva B.V. is indicated for the treatment of: Paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. Paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. Adult patients with Ph+ CML in blast crisis. Adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. Adult patients with relapsed or refractory Ph+ ALL as monotherapy.  Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. Adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR? rearrangement. The effect of imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib Teva B.V. is indicated for: The treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment. The treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "08/05/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/11/2017", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "08/05/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/11/2017", "last_updated_date": "09/10/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imatinib-teva-bv" }, { "category": "Human", "name_of_medicine": "Dexxience", "ema_product_number": "EMEA/H/C/004309", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "betrixaban", "active_substance": "betrixaban maleate", "therapeutic_area_mesh": "Venous Thromboembolism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AF", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of venous thromboembolism", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Portola Pharma UK Limited", "european_commission_decision_date": "20/09/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/07/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "20/09/2018", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2018", "last_updated_date": "09/10/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dexxience" }, { "category": "Veterinary", "name_of_medicine": "Trifexis", "ema_product_number": "EMEA/V/C/002635", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0008", "international_non_proprietary_name_common_name": "spinosad;milbemycin oxime", "active_substance": "spinosad;milbemycin oxime", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QP54AB51", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiparasitic products, insecticides and repellents;Endectocides", "therapeutic_indication": "For the treatment and prevention of flea (Ctenocephalides felis) infestations in dogs where one or more of the following indications are required concurrently:   prevention of heartworm disease (L3, L4 Dirofilaria immitis); prevention of angiostrongylosis by reducing the level of infection with immature adult (L5) Angiostrongylus vasorum; treatment of gastrointestinal nematode infections caused by hookworm (L4, immature adult, L5) and adult Ancylostoma caninum), roundworms (immature adult L5, and adult Toxocara canis and adult Toxascaris leonina) and whipworm (adult Trichuris vulpis).  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly and Company Limited", "european_commission_decision_date": "17/02/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/07/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "23/09/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "17/02/2017", "last_updated_date": "08/10/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/trifexis" }, { "category": "Human", "name_of_medicine": "Treprostinil SciPharm Sàrl", "ema_product_number": "EMEA/H/C/004847", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "treprostinil", "active_substance": "treprostinil", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of chronic thromboembolic pulmonary hypertension", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SciPharm Sàrl", "european_commission_decision_date": "21/09/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "05/09/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/09/2018", "last_updated_date": "21/09/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/treprostinil-scipharm-sarl" }, { "category": "Human", "name_of_medicine": "Angiox", "ema_product_number": "EMEA/H/C/000562", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "EMEA/H/C/000562/IB/0070", "international_non_proprietary_name_common_name": "bivalirudin", "active_substance": "Bivalirudin", "therapeutic_area_mesh": "Acute Coronary Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AE06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention. Angiox should be administered with aspirin and clopidogrel.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "The Medicines Company UK Ltd", "european_commission_decision_date": "25/10/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "21/06/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "25/10/2016", "last_updated_date": "14/09/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/angiox" }, { "category": "Veterinary", "name_of_medicine": "Gripovac 3", "ema_product_number": "EMEA/V/C/000157", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0005", "international_non_proprietary_name_common_name": "inactivated influenza-A virus", "active_substance": "inactivated influenza-A virus", "therapeutic_area_mesh": "", "species_veterinary": "Pigs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI09AA03", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection. Onset of immunity: 7 days after primary vaccination. Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above. Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merial S.A.S. ", "european_commission_decision_date": "04/12/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/01/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "04/12/2014", "last_updated_date": "04/09/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/gripovac-3" }, { "category": "Human", "name_of_medicine": "Intanza", "ema_product_number": "EMEA/H/C/000957", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0054", "international_non_proprietary_name_common_name": "influenza vaccine (split virion, inactivated)", "active_substance": "influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)", "therapeutic_area_mesh": "Influenza, Human;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.The use of Intanza should be based on official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Pasteur Europe", "european_commission_decision_date": "07/09/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/02/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "03/08/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "07/09/2017", "last_updated_date": "04/09/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/intanza" }, { "category": "Human", "name_of_medicine": "Numient", "ema_product_number": "EMEA/H/C/002611", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0005", "international_non_proprietary_name_common_name": "levodopa;carbidopa", "active_substance": "levodopa;carbidopa", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of adult patients with Parkinson’s disease", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amneal Pharma Europe Ltd", "european_commission_decision_date": "03/08/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/09/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "02/04/2019", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "03/08/2018", "last_updated_date": "09/08/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/numient" }, { "category": "Human", "name_of_medicine": "Ariclaim", "ema_product_number": "EMEA/H/C/000552", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0066", "international_non_proprietary_name_common_name": "duloxetine", "active_substance": "duloxetine", "therapeutic_area_mesh": "Diabetic Neuropathies", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetic peripheral neuropathic pain. Ariclaim is indicated in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "09/12/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/08/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/07/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "26", "first_published_date": "09/12/2016", "last_updated_date": "07/08/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ariclaim" }, { "category": "Human", "name_of_medicine": "Restaysis", "ema_product_number": "EMEA/H/C/004229", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ciclosporin", "active_substance": "ciclosporin", "therapeutic_area_mesh": "Dry Eye Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA18", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the treatment of moderate dry eye disease in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Allergan Pharmaceuticals International Limited", "european_commission_decision_date": "01/06/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "25/04/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/06/2018", "last_updated_date": "06/08/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/restaysis" }, { "category": "Human", "name_of_medicine": "Clopidogrel HCS", "ema_product_number": "EMEA/H/C/002255", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0023", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrochloride)", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Acute Coronary Syndrome;Myocardial Infarction;Stroke", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillationIn adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.   For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "HCS bvba ", "european_commission_decision_date": "03/05/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/10/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "03/05/2018", "last_updated_date": "01/08/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-hcs" }, { "category": "Human", "name_of_medicine": "Victrelis", "ema_product_number": "EMEA/H/C/002332", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0042", "international_non_proprietary_name_common_name": "boceprevir", "active_substance": "Boceprevir", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Victrelis is indicated for the treatment of chronic hepatitis-C (CHC) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp Dohme Ltd", "european_commission_decision_date": "29/06/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/07/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "29/06/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "22", "first_published_date": "29/06/2017", "last_updated_date": "31/07/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/victrelis" }, { "category": "Human", "name_of_medicine": "Alsitek", "ema_product_number": "EMEA/H/C/004398", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "masitinib", "active_substance": "Masitinib mesilate", "therapeutic_area_mesh": "Amyotrophic Lateral Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of amyotrophic lateral sclerosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AB Science", "european_commission_decision_date": "20/04/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/04/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "26/07/2018", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/04/2018", "last_updated_date": "31/07/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alsitek" }, { "category": "Human", "name_of_medicine": "Raligize", "ema_product_number": "EMEA/H/C/004473", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Uterine Cervical Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of cervical cancer", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "FGK Representative Service GmbH", "european_commission_decision_date": "27/07/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "10/07/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/07/2018", "last_updated_date": "27/07/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/raligize" }, { "category": "Veterinary", "name_of_medicine": "Certifect", "ema_product_number": "EMEA/V/C/002002", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0011", "international_non_proprietary_name_common_name": "fipronil / amitraz / (S)-methoprene", "active_substance": "fipronil;amitraz;(S)-methoprene", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QP53AX65", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for topical use, incl. insecticides", "therapeutic_indication": "Treatment and prevention of infestations in dogs by ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis, Haemaphysalis elliptica, Haemaphysalis longicornis, Amblyomma americanum and Amblyomma maculatum) and fleas (Ctenocephalides felis and Ctenocephalides canis). Treatment of infestations by chewing lice (Trichodectes canis). Prevention of environmental flea contamination by inhibiting the development of all flea immature stages. The product can be used as part of a treatment strategy for the control of flea-allergy dermatitis. Elimination of fleas and ticks within 24 hours. One treatment prevents further infestations for five weeks by ticks and for up to five weeks by fleas. The treatment indirectly reduces the risk of transmission of tick-borne diseases (canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis) from infected ticks for four weeks.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merial", "european_commission_decision_date": "18/04/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/05/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "18/04/2016", "last_updated_date": "27/07/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/certifect" }, { "category": "Human", "name_of_medicine": "Xeljanz", "ema_product_number": "EMEA/H/C/002542", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tofacitinib", "active_substance": "tofacitinib", "therapeutic_area_mesh": "Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of rheumatoid arthritis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "23/07/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/04/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "25/07/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/07/2018", "last_updated_date": "23/07/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xeljanz-0" }, { "category": "Human", "name_of_medicine": "Topotecan Teva", "ema_product_number": "EMEA/H/C/001071", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0014", "international_non_proprietary_name_common_name": "topotecan", "active_substance": "topotecan", "therapeutic_area_mesh": "Ovarian Neoplasms;Uterine Cervical Neoplasms;Small Cell Lung Carcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy; patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "22/06/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "22/06/2018", "last_updated_date": "13/07/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/topotecan-teva" }, { "category": "Human", "name_of_medicine": "Rotigotine Mylan", "ema_product_number": "EMEA/H/C/004286", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "rotigotine", "active_substance": "rotigotine", "therapeutic_area_mesh": "Restless Legs Syndrome;Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BC09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of idiopathic Restless Legs Syndrome and Parkinson's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan S.A.S", "european_commission_decision_date": "26/01/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "22/12/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/01/2018", "last_updated_date": "11/07/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rotigotine-mylan" }, { "category": "Human", "name_of_medicine": "Maci", "ema_product_number": "EMEA/H/C/002522", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0009", "international_non_proprietary_name_common_name": "matrix-applied characterised autologous cultured chondrocytes", "active_substance": "autologous cultured chondrocytes", "therapeutic_area_mesh": "Fractures, Cartilage", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Repair of symptomatic cartilage defects of the knee.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vericel Denmark ApS", "european_commission_decision_date": "01/07/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/06/2013", "refusal_of_marketing_authorisation_date": "26/04/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/07/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "01/07/2018", "last_updated_date": "05/07/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/maci" }, { "category": "Human", "name_of_medicine": "Prohippur", "ema_product_number": "EMEA/H/C/004150", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "sodium benzoate", "therapeutic_area_mesh": "Urea Cycle Disorders, Inborn;Hyperglycinemia, Nonketotic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AX11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of non ketotic hyperglycinemia, urea cycle disorders including carbamoyl-phosphate synthase-1 deficiency, ornithine transcarbamylase deficiency, citrullinaemia type 1, argininosuccinic aciduria, hyperargininaemia, n-acetylglutamate synthase deficiency, ornithine translocase deficiency and lysinuric protein intolerance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lucane Pharma", "european_commission_decision_date": "27/04/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "03/04/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/04/2018", "last_updated_date": "05/07/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prohippur" }, { "category": "Human", "name_of_medicine": "Zinbryta", "ema_product_number": "EMEA/H/C/003862", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0015", "international_non_proprietary_name_common_name": "daclizumab", "active_substance": "daclizumab", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zinbryta is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biogen Idec Ltd", "european_commission_decision_date": "27/03/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "31/03/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/07/2016", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/03/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "27/03/2018", "last_updated_date": "28/06/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zinbryta" }, { "category": "Human", "name_of_medicine": "Fulphila", "ema_product_number": "EMEA/H/C/004262", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reducing neutropenia in patients taking cancer treatments", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan S.A.S", "european_commission_decision_date": "15/09/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "03/08/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/09/2017", "last_updated_date": "29/05/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fulphila-0" }, { "category": "Human", "name_of_medicine": "Olysio", "ema_product_number": "EMEA/H/C/002777", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010255/201705", "international_non_proprietary_name_common_name": "simeprevir", "active_substance": "simeprevir", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Olysio is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. For hepatitis C virus (HCV) genotype specific activity.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "08/02/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/03/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/05/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/05/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "08/02/2018", "last_updated_date": "23/05/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/olysio" }, { "category": "Veterinary", "name_of_medicine": "BTVPUR AlSap 1", "ema_product_number": "EMEA/V/C/002230", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0005", "international_non_proprietary_name_common_name": "bluetongue-virus serotype-1 antigen", "active_substance": "bluetongue-virus serotype-1 antigen", "therapeutic_area_mesh": "", "species_veterinary": "Sheep;Cattle", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI04AA02", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "Active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotype 1. Onset of immunity has been demonstrated three weeks after the primary vaccination course. The duration of immunity for cattle and sheep is one year after the primary vaccination course.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merial", "european_commission_decision_date": "08/09/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/12/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "08/09/2015", "last_updated_date": "17/05/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/btvpur-alsap-1" }, { "category": "Veterinary", "name_of_medicine": "BTVPUR Alsap 8", "ema_product_number": "EMEA/V/C/000146", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0010", "international_non_proprietary_name_common_name": "adjuvanted bluetongue virus vaccine", "active_substance": "bluetongue virus serotype 8 antigen", "therapeutic_area_mesh": "", "species_veterinary": "Sheep;Cattle", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI02AA08", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for Ovidae;Immunologicals for Bovidae", "therapeutic_indication": "Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.*(below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ml, indicating no infectious virus transmission). Onset of immunity has been demonstrated 3 weeks after the primary vaccination course. The duration of immunity for cattle and sheep is 1 year after the primary vaccination course. The duration of immunity is not yet fully established in cattle or sheep, although interim results of ongoing studies demonstrate that the duration is at least 6 months after the primary vaccination course in sheep.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merial", "european_commission_decision_date": "13/03/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/03/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "13/03/2014", "last_updated_date": "16/05/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/btvpur-alsap-8" }, { "category": "Human", "name_of_medicine": "Vibativ", "ema_product_number": "EMEA/H/C/001240", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0031", "international_non_proprietary_name_common_name": "telavancin", "active_substance": "telavancin", "therapeutic_area_mesh": "Pneumonia, Bacterial;Cross Infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01XA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vibativ is indicated for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA). Vibativ should be used only in situations where it is known or suspected that other alternatives are not suitable. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Theravance Biopharma Ireland Umited", "european_commission_decision_date": "08/09/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/09/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "08/09/2017", "last_updated_date": "16/05/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vibativ-0" }, { "category": "Human", "name_of_medicine": "Prandin", "ema_product_number": "EMEA/H/C/000362", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0070", "international_non_proprietary_name_common_name": "repaglinide", "active_substance": "repaglinide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "06/09/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/01/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "06/09/2017", "last_updated_date": "14/05/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prandin" }, { "category": "Human", "name_of_medicine": "Insulin Human Winthrop", "ema_product_number": "EMEA/H/C/000761", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0081", "international_non_proprietary_name_common_name": "insulin human", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Diabetes mellitus where treatment with insulin is required. Insulin Human Winthrop Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "sanofi-aventis Deutschland GmbH", "european_commission_decision_date": "28/04/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "11/01/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "28/04/2016", "last_updated_date": "30/04/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-human-winthrop" }, { "category": "Veterinary", "name_of_medicine": "Panacur AquaSol", "ema_product_number": "EMEA/V/C/002008", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fenbendazole", "active_substance": "fenbendazole", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anthelmintics;Benzimidazoles and related substances;fenbendazole", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/03/2018", "last_updated_date": "26/04/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/panacur-aquasol" }, { "category": "Human", "name_of_medicine": "Masipro", "ema_product_number": "EMEA/H/C/004159", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "masitinib", "active_substance": "Masitinib mesilate", "therapeutic_area_mesh": "Mastocytosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE22", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of mastocytosis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AB Science", "european_commission_decision_date": "18/12/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "18/12/2017", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/12/2017", "last_updated_date": "04/04/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/masipro" }, { "category": "Human", "name_of_medicine": "Evarrest", "ema_product_number": "EMEA/H/C/002515", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0027/G", "international_non_proprietary_name_common_name": "human fibrinogen;human thrombin", "active_substance": "human fibrinogen;human thrombin", "therapeutic_area_mesh": "Hemostasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BC30", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Local hemostatics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Supportive treatment in adult surgery where standard surgical techniques are insufficient (see section 5.1): - for improvement of haemostasis.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Omrix Biopharmaceuticals N. V.", "european_commission_decision_date": "15/11/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/11/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "15/11/2017", "last_updated_date": "03/04/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evarrest" }, { "category": "Human", "name_of_medicine": "IDflu", "ema_product_number": "EMEA/H/C/000966", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0048", "international_non_proprietary_name_common_name": "influenza vaccine (split virion, inactivated)", "active_substance": "influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)", "therapeutic_area_mesh": "Influenza, Human;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.The use of IDflu should be based on official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Pasteur S.A.", "european_commission_decision_date": "03/01/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/02/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "19/03/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "03/01/2017", "last_updated_date": "29/03/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/idflu" }, { "category": "Human", "name_of_medicine": "Balimek", "ema_product_number": "EMEA/H/C/004052", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "binimetinib", "active_substance": "binimetinib", "therapeutic_area_mesh": "Melanoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of unresectable or metastatic melanoma. Treatment of unresectable melanoma, with NRA Q61 mutation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pierre Fabre Médicament", "european_commission_decision_date": "26/01/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "04/01/2018", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/01/2018", "last_updated_date": "27/03/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/balimek" }, { "category": "Human", "name_of_medicine": "Tasermity", "ema_product_number": "EMEA/H/C/003968", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0006", "international_non_proprietary_name_common_name": "sevelamer hydrochloride", "active_substance": "sevelamer hydrochloride", "therapeutic_area_mesh": "Hyperphosphatemia;Renal Dialysis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AE02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Genzyme Europe BV", "european_commission_decision_date": "15/12/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/02/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "26/02/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "15/12/2017", "last_updated_date": "27/03/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tasermity" }, { "category": "Human", "name_of_medicine": "Fanaptum", "ema_product_number": "EMEA/H/C/004149", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "iloperidone", "active_substance": "iloperidone", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of schizophrenia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vanda Pharmaceuticals Ltd", "european_commission_decision_date": "15/01/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "15/01/2018", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/01/2018", "last_updated_date": "19/03/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fanaptum-0" }, { "category": "Human", "name_of_medicine": "Ristempa", "ema_product_number": "EMEA/H/C/003910", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0010", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "29/09/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/02/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/04/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/09/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "29/09/2017", "last_updated_date": "07/03/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ristempa" }, { "category": "Human", "name_of_medicine": "Infinia", "ema_product_number": "EMEA/H/C/003934", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "alpha-1-antitrypsin", "therapeutic_area_mesh": "Genetic Diseases, Inborn;Lung Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihemorrhagics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment and maintenance therapy of adult patients with congenital deficiency of alpha-1 antitrypsin and lung disease with clinical evidence of emphysema and airway obstruction (FEV1/SVC<70%)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Kamada BioPharma Limited at Fieldfisher LLP", "european_commission_decision_date": "23/06/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "21/06/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/07/2017", "last_updated_date": "16/02/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/infinia" }, { "category": "Human", "name_of_medicine": "LeukoScan", "ema_product_number": "EMEA/H/C/000111", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0024/G", "international_non_proprietary_name_common_name": "sulesomab", "active_substance": "sulesomab", "therapeutic_area_mesh": "Osteomyelitis;Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "VO4D", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers. LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Immunomedics GmbH", "european_commission_decision_date": "18/01/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/02/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "30/01/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "18/01/2017", "last_updated_date": "09/02/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/leukoscan" }, { "category": "Human", "name_of_medicine": "Zafiride", "ema_product_number": "EMEA/H/C/004455", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Mesothelioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of advanced malignant pleural mesothelioma", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "MolMed SpA", "european_commission_decision_date": "23/06/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "01/06/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/06/2017", "last_updated_date": "08/02/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zafiride" }, { "category": "Human", "name_of_medicine": "Libertek", "ema_product_number": "EMEA/H/C/002399", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0031", "international_non_proprietary_name_common_name": "roflumilast", "active_substance": "roflumilast", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03DX08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "11/01/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/02/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "11/01/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "11/01/2018", "last_updated_date": "08/02/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/libertek" }, { "category": "Human", "name_of_medicine": "Daliresp", "ema_product_number": "EMEA/H/C/002398", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0030", "international_non_proprietary_name_common_name": "roflumilast", "active_substance": "roflumilast", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03DX07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "03/11/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/02/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "11/01/2018", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "03/11/2016", "last_updated_date": "06/02/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/daliresp" }, { "category": "Human", "name_of_medicine": "Qizenday", "ema_product_number": "EMEA/H/C/004153", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A11HA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vitamins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of progressive multiple sclerosis (primary or secondary)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Medday Pharmaceuticals", "european_commission_decision_date": "15/12/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/11/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/12/2017", "last_updated_date": "06/02/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qizenday" }, { "category": "Human", "name_of_medicine": "Onzeald", "ema_product_number": "EMEA/H/C/003874", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "etirinotecan pegol", "active_substance": "etirinotecan pegol", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of breast cancer with brain metastases", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Nektar Therapeutics UK Limited", "european_commission_decision_date": "08/01/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "09/11/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "08/01/2018", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/01/2018", "last_updated_date": "02/02/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/onzeald" }, { "category": "Human", "name_of_medicine": "EnCyzix", "ema_product_number": "EMEA/H/C/004198", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "enclomifene", "active_substance": "enclomifene citrate", "therapeutic_area_mesh": "Hypogonadism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03X", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of hypogonadotropic hypogonadism in men", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Renable Pharma Limited", "european_commission_decision_date": "26/01/2018", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "25/01/2018", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "06/04/2018", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/01/2018", "last_updated_date": "26/01/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/encyzix" }, { "category": "Human", "name_of_medicine": "Clopidogrel Acino", "ema_product_number": "EMEA/H/C/001166", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0018/G", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Acute Coronary Syndrome;Myocardial Infarction;Stroke", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA) ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy Patients suffering from acute coronary syndrome.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Acino AG", "european_commission_decision_date": "28/01/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/01/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "28/01/2016", "last_updated_date": "04/01/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-acino" }, { "category": "Human", "name_of_medicine": "Optimark", "ema_product_number": "EMEA/H/C/000745", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0037", "international_non_proprietary_name_common_name": "gadoversetamide", "active_substance": "gadoversetamide", "therapeutic_area_mesh": "Magnetic Resonance Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V08CA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Contrast media", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mallinckrodt Deutschland GmbH", "european_commission_decision_date": "11/04/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/07/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "25/07/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "11/04/2017", "last_updated_date": "11/12/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/optimark" }, { "category": "Human", "name_of_medicine": "Somatropin Biopartners", "ema_product_number": "EMEA/H/C/002196", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0010", "international_non_proprietary_name_common_name": "somatropin", "active_substance": "somatropin", "therapeutic_area_mesh": "Growth", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Somatropin and somatropin agonists;Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (GHD). Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GHD. Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (< -2 standard-deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioPartners GmbH", "european_commission_decision_date": "13/03/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/08/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/11/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "13/03/2017", "last_updated_date": "01/12/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/somatropin-biopartners" }, { "category": "Human", "name_of_medicine": "Adlumiz", "ema_product_number": "EMEA/H/C/003847", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "anamorelin", "active_substance": "anamorelin hydrochloride", "therapeutic_area_mesh": "Cachexia;Anorexia;Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of anorexia, cachexia or unintended weight loss in adult patients with non-small cell lung cancer (NSCLC)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Helsinn Birex Pharmaceuticals Ltd.", "european_commission_decision_date": "16/11/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "16/11/2017", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/11/2017", "last_updated_date": "30/11/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/adlumiz" }, { "category": "Human", "name_of_medicine": "Ogivri", "ema_product_number": "EMEA/H/C/004346", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan S.A.S.", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "03/08/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/09/2017", "last_updated_date": "28/11/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ogivri-0" }, { "category": "Human", "name_of_medicine": "Prevenar", "ema_product_number": "EMEA/H/C/000323", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00002452/201408", "international_non_proprietary_name_common_name": "pneumococcal saccharide conjugated vaccine, adsorbed", "active_substance": "pneumococcal oligosaccharide serotype 18C;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 23F;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 14", "therapeutic_area_mesh": "Pneumococcal Infections;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AL02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age. The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "22/06/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/02/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "21/11/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "22/06/2015", "last_updated_date": "24/11/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prevenar" }, { "category": "Human", "name_of_medicine": "Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech", "ema_product_number": "EMEA/H/C/004388", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "human IgG1 monoclonal antibody specific for human interleukin-1 alpha", "active_substance": "human IgG1 monoclonal antibody specific for human interleukin-1 alpha", "therapeutic_area_mesh": "Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of metastatic colorectal cancer", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "XBiotech Germany GmbH", "european_commission_decision_date": "14/09/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2017", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "08/12/2017", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/09/2017", "last_updated_date": "13/11/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/human-igg1-monoclonal-antibody-specific-human-interleukin-1-alpha-xbiotech" }, { "category": "Human", "name_of_medicine": "Plivensia", "ema_product_number": "EMEA/H/C/004165", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "sirukumab", "therapeutic_area_mesh": "Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of rheumatoid arthritis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "10/11/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "26/10/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/11/2017", "last_updated_date": "10/11/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/plivensia" }, { "category": "Human", "name_of_medicine": "Kyomarc", "ema_product_number": "EMEA/H/C/004360", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "bevacizumab", "active_substance": "bevacizumab", "therapeutic_area_mesh": "Carcinoma, Renal Cell;Carcinoma, Bronchogenic;Fallopian Tube Neoplasms;Breast Neoplasms;Ovarian Neoplasms;Peritoneal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of breast cancer, non-small cell lung cancer, renal cell cancer, advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, platinum-sensitive epithelial ovarian, fallopian tube or primary", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amgen Europe B.V.", "european_commission_decision_date": "10/11/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/10/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/11/2017", "last_updated_date": "10/11/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kyomarc" }, { "category": "Human", "name_of_medicine": "Glybera", "ema_product_number": "EMEA/H/C/002145", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "S/0057", "international_non_proprietary_name_common_name": "alipogene tiparvovec", "active_substance": "alipogene tiparvovec", "therapeutic_area_mesh": "Hyperlipoproteinemia Type I", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AX10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Glybera is indicated for adult patients diagnosed with familial lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions. The diagnosis of LPLD has to be confirmed by genetic testing. The indication is restricted to patients with detectable levels of LPL protein.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "uniQure biopharma B.V. ", "european_commission_decision_date": "20/04/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/10/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/10/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "20/04/2017", "last_updated_date": "30/10/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/glybera" }, { "category": "Human", "name_of_medicine": "Clopidogrel Teva Pharma (previously Clopidogrel HCS)", "ema_product_number": "EMEA/H/C/001133", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0027/G", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrochloride)", "therapeutic_area_mesh": "Myocardial Infarction;Peripheral Vascular Diseases;Stroke", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V. ", "european_commission_decision_date": "22/01/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/06/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "22/01/2016", "last_updated_date": "24/10/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-teva-pharma-0" }, { "category": "Human", "name_of_medicine": "Tigecycline Accord", "ema_product_number": "EMEA/H/C/004419", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "tigecycline", "active_substance": "tigecycline", "therapeutic_area_mesh": "Soft Tissue Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01AA12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of: - complicated skin and soft tissue infections, excluding diabetic foot infections - complicated intra-abdominal infections Tygacil should be used only in situations where it is known or suspected that other alternatives are not suitable", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Accord Healthcare Ltd", "european_commission_decision_date": "15/09/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "12/09/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/09/2017", "last_updated_date": "10/10/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tigecycline-accord-1" }, { "category": "Veterinary", "name_of_medicine": "Cheristin", "ema_product_number": "EMEA/V/C/004316", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QP53AX", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the treatment and prevention of flea infestations (Ctenocephalides felis) on cats.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Elanco Europe Ltd", "european_commission_decision_date": "29/09/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "29/03/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/09/2017", "last_updated_date": "29/09/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/cheristin" }, { "category": "Human", "name_of_medicine": "NovoNorm", "ema_product_number": "EMEA/H/C/000187", "medicine_status": "Authorised", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0090", "international_non_proprietary_name_common_name": "repaglinide", "active_substance": "repaglinide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "05/09/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/08/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "06/09/2017", "last_updated_date": "28/09/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/novonorm" }, { "category": "Human", "name_of_medicine": "Zontivity", "ema_product_number": "EMEA/H/C/002814", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0005", "international_non_proprietary_name_common_name": "vorapaxar", "active_substance": "vorapaxar sulfate", "therapeutic_area_mesh": "Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zontivityis indicated for the reduction of atherothrombotic events in adult patients with a history of myocardial infarction (MI), ,co-administered with acetylsalicylic acid (ASA) and, where appropriate, clopidogrel; or symptomatic peripheral arterial disease (PAD), co-administered with acetylsalicylic acid (ASA) or, where appropriate, clopidogrel.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp Dohme Limited", "european_commission_decision_date": "29/07/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/01/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "23/06/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "29/07/2016", "last_updated_date": "20/09/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zontivity" }, { "category": "Veterinary", "name_of_medicine": "Somnena", "ema_product_number": "EMEA/V/C/004293", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "buprenorphine", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QN02AE01", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Analgesics", "therapeutic_indication": "For the control of post-operative pain in cats for 3 days.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "29/01/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/09/2017", "last_updated_date": "14/09/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/somnena" }, { "category": "Human", "name_of_medicine": "Qinprezo", "ema_product_number": "EMEA/H/C/004118", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "vosaroxin", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment acute myeloid leukaemia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sunesis Europe Ltd", "european_commission_decision_date": "19/05/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "10/05/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/05/2017", "last_updated_date": "15/08/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qinprezo" }, { "category": "Human", "name_of_medicine": "Elmisol", "ema_product_number": "EMEA/H/C/004330", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Nephrotic Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "P02CE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anthelmintics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of steroid sensitive nephrotic syndrome", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ACE Pharmaceuticals BV", "european_commission_decision_date": "23/06/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "29/05/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/06/2017", "last_updated_date": "18/07/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elmisol" }, { "category": "Veterinary", "name_of_medicine": "Recuvyra", "ema_product_number": "EMEA/V/C/002239", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0009/G", "international_non_proprietary_name_common_name": "fentanyl", "active_substance": "fentanyl", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QN02AB03", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Nervous system", "therapeutic_indication": "For the control of pain associated with orthopaedic and soft tissue surgery in dogs.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly and Company Limited ", "european_commission_decision_date": "13/10/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/10/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/10/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "13/10/2016", "last_updated_date": "12/07/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/recuvyra" }, { "category": "Human", "name_of_medicine": "Removab", "ema_product_number": "EMEA/H/C/000972", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0020", "international_non_proprietary_name_common_name": "catumaxomab", "active_substance": "catumaxomab", "therapeutic_area_mesh": "Ascites;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Removab is indicated for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Neovii Biotech GmbH", "european_commission_decision_date": "02/06/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/04/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "02/06/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "02/06/2017", "last_updated_date": "12/07/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/removab" }, { "category": "Human", "name_of_medicine": "Sabervel", "ema_product_number": "EMEA/H/C/002510", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "A31/0005", "international_non_proprietary_name_common_name": "irbesartan", "active_substance": "irbesartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sabervel is indicated in adults for the treatment of essential hypertension. It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharmathen S.A.", "european_commission_decision_date": "04/09/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/04/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "17/04/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "04/09/2014", "last_updated_date": "29/06/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sabervel" }, { "category": "Human", "name_of_medicine": "Cavoley", "ema_product_number": "EMEA/H/C/004342", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neutropenia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "STADA Arzneimittel AG", "european_commission_decision_date": "16/12/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "16/11/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/12/2016", "last_updated_date": "27/06/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cavoley" }, { "category": "Human", "name_of_medicine": "Efgratin", "ema_product_number": "EMEA/H/C/004023", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neutropenia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gedeon Richter Plc.", "european_commission_decision_date": "16/12/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "16/11/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/12/2016", "last_updated_date": "27/06/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/efgratin" }, { "category": "Human", "name_of_medicine": "Optaflu", "ema_product_number": "EMEA/H/C/000758", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0091", "international_non_proprietary_name_common_name": "influenza vaccine (surface antigen, inactivated, prepared in cell cultures)", "active_substance": "influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, wild type)A/Switzerland/9715293/2013 (H3N2) - like strain(A/South Australia/55/2014, wild type)B/Phuket/3073/2013–like strain(B/Utah/9/2014, wild type)", "therapeutic_area_mesh": "Influenza, Human;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications. Optaflu should be used in accordance to official guidance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Seqirus GmbH", "european_commission_decision_date": "12/12/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/06/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "05/06/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "12/12/2016", "last_updated_date": "27/06/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/optaflu" }, { "category": "Human", "name_of_medicine": "Enpaxiq", "ema_product_number": "EMEA/H/C/004193", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Primary Myelofibrosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of myelofibrosis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CTI Life Sciences Limited", "european_commission_decision_date": "24/03/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/02/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/03/2017", "last_updated_date": "09/06/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enpaxiq" }, { "category": "Human", "name_of_medicine": "Solithromycin Triskel EU Services", "ema_product_number": "EMEA/H/C/004179", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "solithromycin", "therapeutic_area_mesh": "Tularemia;Pneumonia;Anthrax", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01FA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of bacterial infections", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Triskel EU Services Ltd", "european_commission_decision_date": "21/04/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "27/03/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/04/2017", "last_updated_date": "02/06/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/solithromycin-triskel-eu-services" }, { "category": "Human", "name_of_medicine": "Vitekta", "ema_product_number": "EMEA/H/C/002577", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/0884", "international_non_proprietary_name_common_name": "elvitegravir", "active_substance": "elvitegravir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences International Ltd", "european_commission_decision_date": "03/11/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/09/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/11/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "03/11/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "03/11/2016", "last_updated_date": "29/05/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vitekta" }, { "category": "Human", "name_of_medicine": "Blectifor", "ema_product_number": "EMEA/H/C/004100", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "caffeine citrate", "active_substance": "Caffeine citrate", "therapeutic_area_mesh": "Bronchopulmonary Dysplasia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated in preterm neonates for the prevention of bronchopulmonary dysplasia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Viridian Pharma Ltd", "european_commission_decision_date": "24/03/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "09/03/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/03/2017", "last_updated_date": "16/05/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/blectifor" }, { "category": "Human", "name_of_medicine": "Imprida", "ema_product_number": "EMEA/H/C/000775", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/0709", "international_non_proprietary_name_common_name": "amlodipine;valsartan", "active_substance": "valsartan;amlodipine (as amlodipine besilate)", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension. Imprida is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd", "european_commission_decision_date": "03/04/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "03/04/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "20", "first_published_date": "03/04/2017", "last_updated_date": "11/05/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imprida" }, { "category": "Human", "name_of_medicine": "Clopidogrel/Acetylsalicylic acid Teva", "ema_product_number": "EMEA/H/C/002272", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0002", "international_non_proprietary_name_common_name": "clopidogrel;acetylsalicylic acid", "active_substance": "clopidogrel;acetylsalicylic acid", "therapeutic_area_mesh": "Acute Coronary Syndrome;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC30", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "combinations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel/Acetylsalicylic acid Teva is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Teva is a fixed?dose combination medicinal product for continuation of therapy in: Non?ST segment elevation acute coronary syndrome (unstable angina or non?Q?wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "03/06/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "26/06/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/09/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "03/06/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "03/06/2016", "last_updated_date": "28/04/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-teva" }, { "category": "Human", "name_of_medicine": "Unituxin", "ema_product_number": "EMEA/H/C/002800", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/10420/201608", "international_non_proprietary_name_common_name": "dinutuximab", "active_substance": "Dinutuximab", "therapeutic_area_mesh": "Neuroblastoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01FX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "United Therapeutics Europe Ltd", "european_commission_decision_date": "20/03/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/08/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "20/03/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "20/03/2017", "last_updated_date": "28/04/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/unituxin" }, { "category": "Human", "name_of_medicine": "Dutrebis", "ema_product_number": "EMEA/H/C/003823", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "lamivudine;raltegravir potassium", "active_substance": "lamivudine;raltegravir potassium", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AR16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use;Antivirals for treatment of HIV infections, combinations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dutrebis is indicated in combination with other anti?retroviral medicinal products for the treatment of human immunodeficiency virus (HIV?1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp Dohme Limited", "european_commission_decision_date": "26/03/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/03/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "24/04/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/03/2015", "last_updated_date": "27/04/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dutrebis" }, { "category": "Human", "name_of_medicine": "Zioxtenzo", "ema_product_number": "EMEA/H/C/004211", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neutropenia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "27/01/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "18/01/2017", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/01/2017", "last_updated_date": "25/04/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zioxtenzo" }, { "category": "Human", "name_of_medicine": "Graspa", "ema_product_number": "EMEA/H/C/004055", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of acute lymphoblastic leukaemia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ERYTECH Pharma S.A.", "european_commission_decision_date": "16/12/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "14/11/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/12/2016", "last_updated_date": "25/04/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/graspa" }, { "category": "Human", "name_of_medicine": "Rasilamlo", "ema_product_number": "EMEA/H/C/002073", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "aliskiren hemifumarate;amlodipine besilate", "active_substance": "aliskiren;amlodipine", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09XA53", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd", "european_commission_decision_date": "25/06/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/04/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "25/06/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "25/06/2015", "last_updated_date": "28/03/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rasilamlo" }, { "category": "Human", "name_of_medicine": "Alendronic Acid / Colecalciferol Mylan", "ema_product_number": "EMEA/H/C/004172", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "alendronate sodium trihydrate;colecalciferol", "therapeutic_area_mesh": "Osteoporosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of postmenopausal osteoporosis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan S.A.S.", "european_commission_decision_date": "24/06/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "27/05/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/06/2016", "last_updated_date": "02/02/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alendronic-acid-colecalciferol-mylan" }, { "category": "Human", "name_of_medicine": "Budesonide/Formoterol Teva", "ema_product_number": "EMEA/H/C/003951", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A31/0002", "international_non_proprietary_name_common_name": "budesonide;formoterol", "active_substance": "Budesonide;formoterol fumarate dihydrate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive;Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only. AsthmaBudesonide/Formoterol Teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?2 adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?2 adrenoceptor agonists.or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?2 adrenoceptor agonists. COPDSymptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "16/12/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "16/12/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "16/12/2016", "last_updated_date": "31/01/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/budesonide-formoterol-teva" }, { "category": "Human", "name_of_medicine": "Budesonide/Formoterol Teva Pharma B.V.", "ema_product_number": "EMEA/H/C/003953", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0004/G", "international_non_proprietary_name_common_name": "budesonide;formoterol fumarate dihydrate", "active_substance": "Budesonide;formoterol", "therapeutic_area_mesh": "Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only. AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?2 adrenoceptor agonist) is appropriate:   or in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?2 adrenoceptor agonists. in patients already adequately controlled on both inhaled corticosteroids and long-acting ?2 adrenoceptor agonists.  ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "16/12/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "16/12/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "16/12/2016", "last_updated_date": "30/01/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/budesonide-formoterol-teva-pharma-bv" }, { "category": "Human", "name_of_medicine": "Vylaer Spiromax", "ema_product_number": "EMEA/H/C/003952", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A31/0003", "international_non_proprietary_name_common_name": "budesonide;formoterol", "active_substance": "Budesonide;formoterol fumarate dihydrate", "therapeutic_area_mesh": "Pulmonary Disease, Chronic Obstructive;Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vylaer Spiromax is indicated in adults 18 years of age and older only. AsthmaVylaer Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?2 adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?2 adrenoceptor agonists.or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?2 adrenoceptor agonists. COPDSymptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "09/01/2017", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/11/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/01/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "09/01/2017", "last_updated_date": "26/01/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vylaer-spiromax" }, { "category": "Human", "name_of_medicine": "Biograstim", "ema_product_number": "EMEA/H/C/000826", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0029", "international_non_proprietary_name_common_name": "filgrastim", "active_substance": "filgrastim", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Colony stimulating factors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Biograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbZ-Pharma GmbH", "european_commission_decision_date": "23/09/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "23/09/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "23/09/2015", "last_updated_date": "19/01/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/biograstim" }, { "category": "Human", "name_of_medicine": "ChondroCelect", "ema_product_number": "EMEA/H/C/000878", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/012/G", "international_non_proprietary_name_common_name": "characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins", "active_substance": "characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins", "therapeutic_area_mesh": "Cartilage Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other drugs for disorders of the musculo-skeletal system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults. Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present. Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1 and 5 cm².", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "TiGenix N.V.", "european_commission_decision_date": "29/07/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "29/07/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "29/07/2016", "last_updated_date": "12/01/2017", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/chondrocelect" }, { "category": "Human", "name_of_medicine": "Capecitabine SUN", "ema_product_number": "EMEA/H/C/002050", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0007", "international_non_proprietary_name_common_name": "capecitabine", "active_substance": "capecitabine", "therapeutic_area_mesh": "Stomach Neoplasms;Breast Neoplasms;Colonic Neoplasms;Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BC06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "capecitabine", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine is indicated for the treatment of metastatic colorectal cancer. Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "21/06/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/06/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "21/06/2021", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "21/06/2016", "last_updated_date": "22/12/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/capecitabine-sun" }, { "category": "Human", "name_of_medicine": "Zemfirza", "ema_product_number": "EMEA/H/C/004003", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "cediranib maleate", "therapeutic_area_mesh": "Ovarian Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE32", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of platinum sensitive relapsed (PSR) ovarian cancer", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "14/10/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "19/09/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/10/2016", "last_updated_date": "21/12/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zemfirza" }, { "category": "Human", "name_of_medicine": "Pemetrexed ditromethamine Hospira", "ema_product_number": "EMEA/H/C/004306", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pemetrexed", "active_substance": "pemetrexed ditromethamine", "therapeutic_area_mesh": "Mesothelioma;Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of malignant pleural mesothelioma and non-small cell lung cancer", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "14/10/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "22/09/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/10/2016", "last_updated_date": "21/12/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-ditromethamine-hospira" }, { "category": "Human", "name_of_medicine": "Celvapan", "ema_product_number": "EMEA/H/C/000982", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0031", "international_non_proprietary_name_common_name": "influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)", "active_substance": "whole virion influenza vaccine, inactivated containing antigen of strain A/California/07/2009 (H1N1)v", "therapeutic_area_mesh": "Disease Outbreaks;Influenza, Human;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza caused by A(H1N1)v 2009 virus. Celvapan should be used in accordance with official guidance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Nanotherapeutics Bohumil, s.r.o.", "european_commission_decision_date": "30/11/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/03/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "21/11/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "30/11/2015", "last_updated_date": "21/12/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/celvapan" }, { "category": "Human", "name_of_medicine": "Kepnetic", "ema_product_number": "EMEA/H/C/004176", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Distal Myopathies", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Hereditary Inclusion Body Myopathy (HIBM)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ultragenyx UK Limited", "european_commission_decision_date": "16/12/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "10/11/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/12/2016", "last_updated_date": "16/12/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kepnetic" }, { "category": "Human", "name_of_medicine": "Ertapenem Hospira", "ema_product_number": "EMEA/H/C/004080", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "ertapenem", "active_substance": "ertapenem sodium", "therapeutic_area_mesh": "Bacterial Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01DH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of bacterial infections and prophylaxis of surgical site infection following elective colorectal surgery.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Hospira UK Limited", "european_commission_decision_date": "14/10/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/09/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/10/2016", "last_updated_date": "06/12/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ertapenem-hospira" }, { "category": "Human", "name_of_medicine": "Pantecta Control", "ema_product_number": "EMEA/H/C/001099", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/0634", "international_non_proprietary_name_common_name": "pantoprazole", "active_substance": "pantoprazole", "therapeutic_area_mesh": "Gastroesophageal Reflux", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A02BC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Proton pump inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda GmbH", "european_commission_decision_date": "19/09/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/06/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "19/09/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "19/09/2016", "last_updated_date": "15/11/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pantecta-control" }, { "category": "Human", "name_of_medicine": "Cokiera", "ema_product_number": "EMEA/H/C/004235", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AX66", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of hepatitis C", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AbbVie Ltd", "european_commission_decision_date": "16/09/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "03/08/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/09/2016", "last_updated_date": "24/10/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cokiera" }, { "category": "Human", "name_of_medicine": "Arikayce", "ema_product_number": "EMEA/H/C/003936", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "amikacin sulfate", "therapeutic_area_mesh": "Mycobacterium Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01GB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Arikayce is indicated for: treatment of Mycobacterium avium Complex (MAC) lung disease in adult patients who have persistent positive sputum cultures despite the use of medically appropriate first-line therapy Consideration should be given to official guidance on the appropriate use of antibacterial agents. Arikayce should be added to existing therapy and should not be used as monotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Insmed Limited", "european_commission_decision_date": "24/06/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "08/06/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/06/2016", "last_updated_date": "14/10/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/arikayce" }, { "category": "Human", "name_of_medicine": "Incivo", "ema_product_number": "EMEA/H/C/002313", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0035", "international_non_proprietary_name_common_name": "telaprevir", "active_substance": "telaprevir", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis): who are treatment naïve; who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International N.V.", "european_commission_decision_date": "25/06/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/09/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/09/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "25/06/2015", "last_updated_date": "06/10/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/incivo" }, { "category": "Human", "name_of_medicine": "Opsiria", "ema_product_number": "EMEA/H/C/003978", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "sirolimus", "active_substance": "sirolimus", "therapeutic_area_mesh": "Uveitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA23", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Not assigned yet", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Santen Oy", "european_commission_decision_date": "27/05/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/05/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/05/2016", "last_updated_date": "30/09/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opsiria" }, { "category": "Human", "name_of_medicine": "Docetaxel SUN", "ema_product_number": "EMEA/H/C/004086", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "docetaxel", "active_substance": "", "therapeutic_area_mesh": "Prostatic Neoplasms;Carcinoma, Non-Small-Cell Lung;Gastrointestinal Neoplasms;Breast Neoplasms;Head and Neck Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, head and neck cancer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "24/06/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "06/06/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/06/2016", "last_updated_date": "29/09/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/docetaxel-sun" }, { "category": "Human", "name_of_medicine": "Kyndrisa", "ema_product_number": "EMEA/H/C/003846", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Muscular Dystrophy, Duchenne", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M09AX04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Duchenne muscular dystrophy (DMD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioMarin International Limited", "european_commission_decision_date": "24/06/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "31/05/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/06/2016", "last_updated_date": "06/09/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kyndrisa" }, { "category": "Human", "name_of_medicine": "Zoledronic acid Teva Generics", "ema_product_number": "EMEA/H/C/002805", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0002", "international_non_proprietary_name_common_name": "zoledronic acid", "active_substance": "zoledronic acid monohydrate", "therapeutic_area_mesh": "Osteoporosis;Osteitis Deformans", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Bisphosphonates", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in post-menopausal women in adult men at increased risk of fracture, including those with recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women in adult men at increased risk of fracture. Treatment of Paget's disease of the bone in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Generics B.V", "european_commission_decision_date": "13/07/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/01/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/03/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/07/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "13/07/2015", "last_updated_date": "08/08/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zoledronic-acid-teva-generics" }, { "category": "Human", "name_of_medicine": "Osigraft", "ema_product_number": "EMEA/H/C/000293", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/0473/G", "international_non_proprietary_name_common_name": "eptotermin alfa", "active_substance": "eptotermin alfa", "therapeutic_area_mesh": "Tibial Fractures", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases;Bone morphogenetic proteins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of nonunion of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Olympus Biotech International Limited", "european_commission_decision_date": "22/08/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/05/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "17/12/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "22/08/2014", "last_updated_date": "27/07/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/osigraft" }, { "category": "Human", "name_of_medicine": "Dropcys", "ema_product_number": "EMEA/H/C/004038", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "mercaptamine", "active_substance": "mercaptamine", "therapeutic_area_mesh": "Corneal Diseases;Cystinosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01XA21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of corneal cystine deposits", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lucane Pharma", "european_commission_decision_date": "24/06/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "01/04/2016", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "24/06/2016", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/06/2016", "last_updated_date": "25/07/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dropcys" }, { "category": "Human", "name_of_medicine": "Krystexxa", "ema_product_number": "EMEA/H/C/002208", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00010046/201501", "international_non_proprietary_name_common_name": "pegloticase", "active_substance": "pegloticase", "therapeutic_area_mesh": "Gout", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M04AX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antigout preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Krystexxa is indicated for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Crealta Pharmaceuticals Ireland Limited", "european_commission_decision_date": "30/06/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/01/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "30/06/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "30/06/2016", "last_updated_date": "22/07/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/krystexxa" }, { "category": "Human", "name_of_medicine": "Begedina", "ema_product_number": "EMEA/H/C/004144", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "begelomab", "therapeutic_area_mesh": "Graft vs Host Disease;Hematopoietic Stem Cell Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA35", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of graft-versus-host disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Adienne S.r.l. S.U.", "european_commission_decision_date": "22/07/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "04/07/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/07/2016", "last_updated_date": "22/07/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/begedina" }, { "category": "Human", "name_of_medicine": "Opgenra", "ema_product_number": "EMEA/H/C/000819", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/0473/G", "international_non_proprietary_name_common_name": "eptotermin alfa", "active_substance": "eptotermin alfa", "therapeutic_area_mesh": "Spondylolisthesis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Olympus Biotech International Limited", "european_commission_decision_date": "01/07/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/02/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/07/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "01/07/2016", "last_updated_date": "14/07/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opgenra" }, { "category": "Human", "name_of_medicine": "Xegafri", "ema_product_number": "EMEA/H/C/004053", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Not assigned yet", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Clovis Oncology UK Ltd", "european_commission_decision_date": "27/05/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "05/05/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/05/2016", "last_updated_date": "22/06/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xegafri" }, { "category": "Human", "name_of_medicine": "Pandemrix", "ema_product_number": "EMEA/H/C/000832", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0079", "international_non_proprietary_name_common_name": "influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)", "active_substance": "split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Influenza vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza caused by A (H1N1)v 2009 virus. Pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8). Pandemrix should be used in accordance with Official Guidance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "28/04/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/05/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/08/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "28/04/2016", "last_updated_date": "10/06/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pandemrix" }, { "category": "Human", "name_of_medicine": "Avandamet", "ema_product_number": "EMEA/H/C/000522", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "A20/0063", "international_non_proprietary_name_common_name": "rosiglitazone;metformin", "active_substance": "rosiglitazone;metformin hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients: who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SmithKline Beecham Plc", "european_commission_decision_date": "03/12/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/10/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "20/10/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "03/12/2010", "last_updated_date": "08/06/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/avandamet" }, { "category": "Human", "name_of_medicine": "Avandia", "ema_product_number": "EMEA/H/C/000268", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "A20/0075", "international_non_proprietary_name_common_name": "rosiglitazone", "active_substance": "rosiglitazone", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus: as monotherapy-in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with-metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin-a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylurea as triple oral therapy in combination with-metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SmithKline Beecham Plc", "european_commission_decision_date": "03/12/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/07/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "11/07/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "23", "first_published_date": "03/12/2010", "last_updated_date": "08/06/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/avandia" }, { "category": "Veterinary", "name_of_medicine": "RevitaCAM", "ema_product_number": "EMEA/V/C/002379", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0006", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QM01AC06", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Oxicams", "therapeutic_indication": "Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders in dogs.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zoetis Belgium SA", "european_commission_decision_date": "05/10/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/02/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "05/10/2015", "last_updated_date": "30/05/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/revitacam" }, { "category": "Veterinary", "name_of_medicine": "Lodipressin", "ema_product_number": "EMEA/V/C/003786", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "amlodipine", "active_substance": "amlodipine besilate", "therapeutic_area_mesh": "", "species_veterinary": "Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QC08CA01", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Calcium channel blockers", "therapeutic_indication": "Treatment of systemic arterial hypertension in cats.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Le Vet Beheer B.V.", "european_commission_decision_date": "08/07/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "07/05/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "08/07/2015", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/07/2015", "last_updated_date": "29/04/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/lodipressin" }, { "category": "Human", "name_of_medicine": "Repso", "ema_product_number": "EMEA/H/C/001222", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0020", "international_non_proprietary_name_common_name": "leflunomide", "active_substance": "leflunomide", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Arthritis, Psoriatic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a ‘disease-modifying antirheumatic drug’ (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva B.V.", "european_commission_decision_date": "30/03/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/03/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "19/07/2017", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "30/03/2016", "last_updated_date": "21/04/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/repso" }, { "category": "Human", "name_of_medicine": "Kepivance", "ema_product_number": "EMEA/H/C/000609", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0045", "international_non_proprietary_name_common_name": "palifermin", "active_substance": "palifermin", "therapeutic_area_mesh": "Mucositis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AF08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "All other therapeutic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous-haematopoietic-stem-cell support.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Swedish Orphan Biovitrum AB (publ)", "european_commission_decision_date": "01/04/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/10/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/04/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "01/04/2016", "last_updated_date": "08/04/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kepivance" }, { "category": "Human", "name_of_medicine": "Heparesc", "ema_product_number": "EMEA/H/C/003750", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "human heterologous liver cells", "active_substance": "human heterologous liver cells", "therapeutic_area_mesh": "Urea Cycle Disorders, Inborn", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other alimentary tract and metabolism products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of urea cycle disorders (UCD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cytonet GmbH KG", "european_commission_decision_date": "22/10/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/10/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "21/12/2015", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/10/2015", "last_updated_date": "04/04/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/heparesc" }, { "category": "Human", "name_of_medicine": "Aripiprazole Mylan", "ema_product_number": "EMEA/H/C/004236", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "aripiprazole", "active_substance": "aripiprazole", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of schizophrenia, treatment and prevention of bipolar disorder (manic episodes).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan S.A.S.", "european_commission_decision_date": "29/01/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "08/01/2016", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/01/2016", "last_updated_date": "29/03/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aripiprazole-mylan-0" }, { "category": "Human", "name_of_medicine": "Nuedexta", "ema_product_number": "EMEA/H/C/002560", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0005", "international_non_proprietary_name_common_name": "dextromethorphan hydrobromide;quinidine sulfate", "active_substance": "dextromethorphan;quinidine", "therapeutic_area_mesh": "Neurobehavioral Manifestations", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07XX59", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other nervous system drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults. Efficacy has only been studied in patients with underlying amyotrophic lateral sclerosis or multiple sclerosis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Jenson Pharmaceutical Services Limited", "european_commission_decision_date": "24/10/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/06/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/02/2016", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "24/10/2014", "last_updated_date": "11/03/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nuedexta" }, { "category": "Human", "name_of_medicine": "Paglitaz", "ema_product_number": "EMEA/H/C/002309", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0002", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as monotherapy in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "15/01/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/03/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "15/01/2014", "last_updated_date": "10/03/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/paglitaz" }, { "category": "Human", "name_of_medicine": "Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics", "ema_product_number": "EMEA/H/C/002269", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/10008", "international_non_proprietary_name_common_name": "prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)", "active_substance": "influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1)", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunisation against H5N1 subtype of Influenza A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/Vietnam/1194/2004 (H5N1)-like strain. Prepandemic influenza vaccine (H5N1) Novartis Vaccines and Diagnostic should be used in accordance with official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Vaccines and Diagnostics S.r.l.", "european_commission_decision_date": "28/07/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/11/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/11/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "28/07/2015", "last_updated_date": "07/03/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prepandemic-influenza-vaccine-h5n1-surface-antigen-inactivated-adjuvanted-novartis-vaccines-diagnostics" }, { "category": "Human", "name_of_medicine": "Solumarv", "ema_product_number": "EMEA/H/C/003858", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "insulin human", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Marvel Lifesciences Ltd", "european_commission_decision_date": "11/02/2016", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "11/02/2016", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/02/2016", "last_updated_date": "16/02/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/solumarv-0" }, { "category": "Human", "name_of_medicine": "Focetria", "ema_product_number": "EMEA/H/C/000710", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUV/0033", "international_non_proprietary_name_common_name": "influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)", "active_substance": "Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Influenza vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza caused by A (H1N1v) 2009 virus. Focetria should be used in accordance with official guidance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Vaccines and Diagnostics S.r.l.", "european_commission_decision_date": "15/01/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/05/2007", "refusal_of_marketing_authorisation_date": "07/05/2007", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/08/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "15/01/2015", "last_updated_date": "11/02/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/focetria" }, { "category": "Human", "name_of_medicine": "Nivolumab BMS", "ema_product_number": "EMEA/H/C/003840", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "nivolumab", "active_substance": "nivolumab", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic and immunomodulating agents;Monoclonal antibodies", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "30/11/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/05/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/07/2015", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "30/11/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/11/2015", "last_updated_date": "14/01/2016", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nivolumab-bms" }, { "category": "Veterinary", "name_of_medicine": "Dicural", "ema_product_number": "EMEA/V/C/000031", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0021", "international_non_proprietary_name_common_name": "difloxacin", "active_substance": "difloxacin", "therapeutic_area_mesh": "", "species_veterinary": "Turkeys;Dogs;Cattle;Chicken", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QJ01MA94", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use;Antiinfectives for systemic use", "therapeutic_indication": "Chickens: for the treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum. Turkeys: For the treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum. Also for the treatment of infections caused by Pasteurella multocida. Dogs: For the treatment of acute uncomplicated urinary-tract infections caused by Escherichia coli or Staphylococcus spp. and superficial pyoderma caused by Staphylococcus intermedius. Cattle: For the treatment of bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida and / or Mycoplasma spp.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "28/10/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/01/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "28/10/2015", "last_updated_date": "29/10/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/dicural" }, { "category": "Human", "name_of_medicine": "Veraseal", "ema_product_number": "EMEA/H/C/003914", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "human fibrinogen;human thrombin", "therapeutic_area_mesh": "Hemostasis, Surgical", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Supportive treatment for improvement of haemostasis and as a suture support in vascular surgery", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Instituto Grifols, S.A. ", "european_commission_decision_date": "23/10/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "29/09/2015", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/10/2015", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/veraseal-0" }, { "category": "Human", "name_of_medicine": "Sonata", "ema_product_number": "EMEA/H/C/000227", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUSA/00003140/201407", "international_non_proprietary_name_common_name": "zaleplon", "active_substance": "zaleplon", "therapeutic_area_mesh": "Sleep Initiation and Maintenance Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05CF03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Meda AB", "european_commission_decision_date": "03/07/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/03/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "03/07/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "03/07/2015", "last_updated_date": "21/10/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sonata" }, { "category": "Veterinary", "name_of_medicine": "Oxapex", "ema_product_number": "EMEA/V/C/002794", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Oxapex is indicated for the treatment of oxygen debt in dogs caused by haemorrhage and haemorrhagic shock and the minimisation of the time to oxygen debt resolution.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "New A Innovation (NL) Limited B.V.", "european_commission_decision_date": "12/12/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "04/12/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/07/2015", "last_updated_date": "29/07/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/oxapex" }, { "category": "Human", "name_of_medicine": "Aripiprazole Mylan", "ema_product_number": "EMEA/H/C/003926", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "aripiprazole", "active_substance": "aripiprazole", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of schizophrenia and treatment and prevention of manic episodes in bipolar I disorder", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Generics (UK) Limited", "european_commission_decision_date": "22/05/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "07/05/2015", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2015", "last_updated_date": "20/07/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aripiprazole-mylan" }, { "category": "Human", "name_of_medicine": "Lympreva", "ema_product_number": "EMEA/H/C/002772", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dasiprotimut-t", "active_substance": "dasiprotimut-t", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of non-Hodgkins lymphoma (FL)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Biovest Europe Ltd", "european_commission_decision_date": "03/07/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/04/2015", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "03/07/2015", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "03/07/2015", "last_updated_date": "17/07/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lympreva" }, { "category": "Veterinary", "name_of_medicine": "ProMeris", "ema_product_number": "EMEA/V/C/000107", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0012", "international_non_proprietary_name_common_name": "metaflumizone", "active_substance": "metaflumizone", "therapeutic_area_mesh": "", "species_veterinary": "Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QP53AX25", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for topical use, incl. insecticides", "therapeutic_indication": "Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats. The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited ", "european_commission_decision_date": "08/07/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/12/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "08/07/2015", "last_updated_date": "13/07/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/promeris" }, { "category": "Veterinary", "name_of_medicine": "ProMeris Duo", "ema_product_number": "EMEA/V/C/000108", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0011", "international_non_proprietary_name_common_name": "metaflumizone;amitraz", "active_substance": "metaflumizone;amitraz", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QP53AD51", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Ectoparasiticides for topical use, incl. insecticides", "therapeutic_indication": "For the treatment and prevention of infestations by fleas (Ctenocephalides canis and C. felis), and ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus and Dermacentor variabilis), and treatment of demodicosis (caused by Demodex spp.) and lice (Trichodectes canis) in dogs. The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited ", "european_commission_decision_date": "08/07/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/12/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "08/07/2015", "last_updated_date": "13/07/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/promeris-duo" }, { "category": "Human", "name_of_medicine": "Rienso", "ema_product_number": "EMEA/H/C/002215", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "PSUV/0015", "international_non_proprietary_name_common_name": "ferumoxytol", "active_substance": "Ferumoxytol", "therapeutic_area_mesh": "Anemia;Kidney Failure, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD). The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "13/04/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/06/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/04/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "13/04/2015", "last_updated_date": "13/07/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rienso" }, { "category": "Human", "name_of_medicine": "Clopidogrel DURA", "ema_product_number": "EMEA/H/C/001132", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0017", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrochloride)", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan dura GmbH", "european_commission_decision_date": "05/05/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "05/05/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "05/05/2015", "last_updated_date": "10/07/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-dura" }, { "category": "Human", "name_of_medicine": "Corluxin", "ema_product_number": "EMEA/H/C/002830", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "mifepristone", "therapeutic_area_mesh": "Cushing Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "Not yet assigned", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Cushings syndrome", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "FGK Representative Service GmbH", "european_commission_decision_date": "24/04/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "23/03/2015", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2015", "last_updated_date": "12/06/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/corluxin" }, { "category": "Human", "name_of_medicine": "Ketoconazole AID-SCFM", "ema_product_number": "EMEA/H/C/003800", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "ketoconazole", "active_substance": "Ketoconazole", "therapeutic_area_mesh": "Cushing Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Cushings syndrome", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Agenzia Industrie Difesa-Stabilimento Chimico Farmaceutico Militare", "european_commission_decision_date": "10/04/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "23/02/2015", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/03/2015", "last_updated_date": "20/05/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ketoconazole-aid-scfm" }, { "category": "Human", "name_of_medicine": "Provenge", "ema_product_number": "EMEA/H/C/002513", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T)", "active_substance": "autologous peripheral-blood mononuclear cells including a minimum of 50 million autologous CD54+ cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AX17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Provenge is indicated for treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "Yes", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dendreon UK Ltd", "european_commission_decision_date": "06/05/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/09/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "06/05/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "06/05/2015", "last_updated_date": "19/05/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/provenge" }, { "category": "Human", "name_of_medicine": "Duloxetine Sandoz", "ema_product_number": "EMEA/H/C/004009", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "duloxetine", "active_substance": "duloxetine", "therapeutic_area_mesh": "Anxiety Disorders;Neuralgia;Diabetes Mellitus;Depressive Disorder, Major", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment in adults of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sandoz GmbH", "european_commission_decision_date": "24/04/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "08/04/2015", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/04/2015", "last_updated_date": "24/04/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duloxetine-sandoz" }, { "category": "Human", "name_of_medicine": "BindRen", "ema_product_number": "EMEA/H/C/002377", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0004", "international_non_proprietary_name_common_name": "colestilan", "active_substance": "colestilan", "therapeutic_area_mesh": "Hyperphosphatemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of hyperphosphataemia in adult patients with chronic kidney disease stage 5 receiving haemodialysis or peritoneal dialysis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mitsubishi Pharma Europe Ltd", "european_commission_decision_date": "26/03/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/01/2013", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "26/05/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "26/03/2015", "last_updated_date": "01/04/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bindren" }, { "category": "Human", "name_of_medicine": "Pumarix", "ema_product_number": "EMEA/H/C/001212", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "P46/0016", "international_non_proprietary_name_common_name": "pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)", "active_substance": "pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) ", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in an officially declared pandemic situation. Pandemic-influenza vaccine should be used in accordance with official guidance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "28/02/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/03/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "11/02/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "28/02/2014", "last_updated_date": "17/03/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pumarix" }, { "category": "Human", "name_of_medicine": "Docetaxel Mylan", "ema_product_number": "EMEA/H/C/002317", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0006", "international_non_proprietary_name_common_name": "docetaxel", "active_substance": "docetaxel", "therapeutic_area_mesh": "Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan S.A.S.", "european_commission_decision_date": "01/02/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/01/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "31/01/2015", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "01/02/2015", "last_updated_date": "12/03/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/docetaxel-mylan-0" }, { "category": "Veterinary", "name_of_medicine": "Slentrol", "ema_product_number": "EMEA/V/C/000116", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0007/G", "international_non_proprietary_name_common_name": "dirlotapide", "active_substance": "dirlotapide", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QA08AB91", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiobesity preparations, excl. diet products", "therapeutic_indication": "As an aid in the management of overweight and obesity in adult dogs. To be used as part of an overall weight-management programme that also includes appropriate dietary changes and exercise practice.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zoetis Belgium SA", "european_commission_decision_date": "15/01/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/04/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "15/01/2015", "last_updated_date": "24/02/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/slentrol" }, { "category": "Veterinary", "name_of_medicine": "Oncept Melanoma", "ema_product_number": "EMEA/V/C/003684", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merial S.A.S.", "european_commission_decision_date": "24/02/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/07/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/02/2015", "last_updated_date": "24/02/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/oncept-melanoma" }, { "category": "Human", "name_of_medicine": "Egranli", "ema_product_number": "EMEA/H/C/002637", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of neutropenia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "26/09/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "04/11/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/11/2014", "last_updated_date": "16/02/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/egranli" }, { "category": "Human", "name_of_medicine": "Imagify", "ema_product_number": "EMEA/H/C/002347", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "perflubutane", "therapeutic_area_mesh": "Ultrasonography", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V08D", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "ultrasound imaging agent indicated for the detection of coronary artery disease (CAD)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Acusphere Ltd", "european_commission_decision_date": "28/08/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "24/07/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/08/2014", "last_updated_date": "04/02/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imagify" }, { "category": "Veterinary", "name_of_medicine": "TruScient", "ema_product_number": "EMEA/V/C/002000", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0005/G", "international_non_proprietary_name_common_name": "dibotermin alfa", "active_substance": "dibotermin alfa", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QM05BC01", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Bone morphogenetic proteins", "therapeutic_indication": "Osteoinductive agent for use in the treatment of long-bone fractures as an adjunct to standard surgical care using open fracture reduction in dogs.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Zoetis Belgium SA", "european_commission_decision_date": "15/01/2015", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/12/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "15/01/2015", "last_updated_date": "03/02/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/truscient" }, { "category": "Human", "name_of_medicine": "Clopidogrel Teva Pharma B.V.", "ema_product_number": "EMEA/H/C/001226", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0009/G", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrobromide)", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Acute Coronary Syndrome;Myocardial Infarction;Stroke", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of atherothrombotic events Clopidogrel is indicated in: adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease; adult patients suffering from acute coronary syndrome: non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V. ", "european_commission_decision_date": "21/10/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/06/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "21/10/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "21/10/2014", "last_updated_date": "03/02/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-teva-pharma-bv" }, { "category": "Veterinary", "name_of_medicine": "Purevax RCCh", "ema_product_number": "EMEA/V/C/000092", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0007", "international_non_proprietary_name_common_name": "vaccine against feline viral rhinotracheitis, feline calicivirosis and feline Chlamydophila infections", "active_substance": "attenuated feline rhinotracheitis herpesvirus (FHV F2 strain);inactivated feline calicivirosis antigens (FCV 431 and G1 strains);attenuated Chlamydophila felis (905 strain)", "therapeutic_area_mesh": "", "species_veterinary": "Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI06AH", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for felidae", "therapeutic_indication": "Active immunisation of cats aged 8 weeks and older: against feline viral rhinotracheitis to reduce clinical signs; against calicivirus infection to reduce clinical signs and excretion; against Chlamydophila felis infection to reduce clinical signs. Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and Chlamydophila felis components. The duration of immunity is 1 year after the last (re-)vaccination.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merial", "european_commission_decision_date": "12/02/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/02/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/02/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "12/02/2014", "last_updated_date": "22/01/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/purevax-rcch" }, { "category": "Human", "name_of_medicine": "Vistide", "ema_product_number": "EMEA/H/C/000121", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0034", "international_non_proprietary_name_common_name": "cidofovir", "active_substance": "cidofovir", "therapeutic_area_mesh": "Cytomegalovirus Retinitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AB12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Vistide is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Vistide should be used only when other agents are considered unsuitable.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gilead Sciences International Limited", "european_commission_decision_date": "22/08/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/04/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/08/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "21", "first_published_date": "22/08/2014", "last_updated_date": "19/01/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vistide" }, { "category": "Human", "name_of_medicine": "Masiviera", "ema_product_number": "EMEA/H/C/002659", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "masitinib", "active_substance": "masitinib", "therapeutic_area_mesh": "Pancreatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of non resectable locally advanced or metastatic pancreatic cancer", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AB Science", "european_commission_decision_date": "23/01/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/01/2014", "last_updated_date": "06/01/2015", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/masiviera" }, { "category": "Human", "name_of_medicine": "Ipreziv", "ema_product_number": "EMEA/H/C/002517", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A31/0006", "international_non_proprietary_name_common_name": "azilsartan medoxomil", "active_substance": "azilsartan medoxomil", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ipreziv is indicated for the treatment of essential hypertension in adults.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Pharma A/S", "european_commission_decision_date": "27/10/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/12/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/10/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "27/10/2014", "last_updated_date": "19/12/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ipreziv" }, { "category": "Human", "name_of_medicine": "Fluenz", "ema_product_number": "EMEA/H/C/001101", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0056", "international_non_proprietary_name_common_name": "influenza vaccine (live attenuated, nasal)", "active_substance": "reassortant influenza virus (live attenuated) of the following strains:A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 (H3N2) like strain, B/Massachusetts/2/2012 like strain", "therapeutic_area_mesh": "Influenza, Human;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in individuals 24 months to less than 18 years of age. The use of Fluenz should be based on official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "Yes", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "MedImmune LLC", "european_commission_decision_date": "21/10/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/01/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/10/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "21/10/2013", "last_updated_date": "03/12/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fluenz-0" }, { "category": "Human", "name_of_medicine": "Neofordex", "ema_product_number": "EMEA/H/C/002418", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "dexamethasone", "active_substance": "dexamethasone", "therapeutic_area_mesh": "Multiple Myeloma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H02AB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic multiple myeloma", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoires CTRS - Boulogne Billancourt", "european_commission_decision_date": "25/07/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/07/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/07/2014", "last_updated_date": "20/11/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neofordex-0" }, { "category": "Human", "name_of_medicine": "Topotecan Eagle", "ema_product_number": "EMEA/H/C/002261", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0001", "international_non_proprietary_name_common_name": "topotecan", "active_substance": "topotecan hydrochloride", "therapeutic_area_mesh": "Carcinoma;Small Cell Lung Carcinoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic and immunomodulating agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eagle Laboratories Ltd.   ", "european_commission_decision_date": "02/10/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/12/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "02/10/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "02/10/2014", "last_updated_date": "14/11/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/topotecan-eagle" }, { "category": "Veterinary", "name_of_medicine": "Enthryv", "ema_product_number": "EMEA/V/C/002808", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Nexcyon Pharmaceuticals Ltd", "european_commission_decision_date": "06/11/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "30/06/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/11/2014", "last_updated_date": "06/11/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/enthryv" }, { "category": "Human", "name_of_medicine": "Doribax", "ema_product_number": "EMEA/H/C/000891", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0022", "international_non_proprietary_name_common_name": "doripenem", "active_substance": "doripenem", "therapeutic_area_mesh": "Pneumonia, Ventilator-Associated;Pneumonia, Bacterial;Urinary Tract Infections;Bacterial Infections;Cross Infection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01DH04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Doribax is indicated for the treatment of the following infections in adults: nosocomial pneumonia (including ventilator-associated pneumonia); complicated intra-abdominal infections; complicated urinary tract infections. Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "21/02/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/07/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "31/07/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "21/02/2012", "last_updated_date": "17/10/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/doribax" }, { "category": "Human", "name_of_medicine": "Pioglitazone Krka", "ema_product_number": "EMEA/H/C/002453", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0001", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "16/09/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "16/09/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "16/09/2014", "last_updated_date": "26/09/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pioglitazone-krka" }, { "category": "Human", "name_of_medicine": "Rivastigmine 3M Health Care Ltd", "ema_product_number": "EMEA/H/C/003824", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rivastigmine", "active_substance": "rivastigmine", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics;Anticholinesterases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of mild to moderately severe Alzheimer's dementia.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "3M Health Care Limited", "european_commission_decision_date": "19/08/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/01/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/04/2014", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "19/08/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "19/08/2014", "last_updated_date": "18/09/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rivastigmine-3m-health-care-ltd" }, { "category": "Human", "name_of_medicine": "Faldaprevir Boehringer Ingelheim", "ema_product_number": "EMEA/H/C/003720", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "faldaprevir", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of chronic genotype-1 hepatitis C virus (HCV) infection.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "27/06/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "10/06/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/06/2014", "last_updated_date": "16/09/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/faldaprevir-boehringer-ingelheim" }, { "category": "Human", "name_of_medicine": "Clopidogrel Qualimed", "ema_product_number": "EMEA/H/C/001135", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0008", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrochloride)", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Qualimed", "european_commission_decision_date": "01/09/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/09/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "01/09/2014", "last_updated_date": "08/09/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-qualimed" }, { "category": "Human", "name_of_medicine": "Reasanz", "ema_product_number": "EMEA/H/C/002817", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "serelaxin", "active_substance": "serelaxin", "therapeutic_area_mesh": "Heart Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01DX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other vasodilators used in cardiac diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of acute heart failure", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd", "european_commission_decision_date": "05/08/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "05/08/2014", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "05/08/2014", "last_updated_date": "01/09/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/reasanz" }, { "category": "Human", "name_of_medicine": "Nerventra", "ema_product_number": "EMEA/H/C/002546", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "laquinimod", "active_substance": "laquinimod", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of multiple sclerosis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma GmbH", "european_commission_decision_date": "20/12/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "22/05/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "19/08/2014", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/12/2013", "last_updated_date": "01/09/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nerventra" }, { "category": "Human", "name_of_medicine": "Ioa", "ema_product_number": "EMEA/H/C/002068", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A31/0007", "international_non_proprietary_name_common_name": "nomegestrol acetate;estradiol", "active_substance": "nomegestrol acetate;estradiol", "therapeutic_area_mesh": "Contraception", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03AA14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Oral contraception.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Organon N.V.", "european_commission_decision_date": "16/01/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/11/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "31/07/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "16/01/2014", "last_updated_date": "26/08/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ioa" }, { "category": "Human", "name_of_medicine": "Neocepri", "ema_product_number": "EMEA/H/C/002773", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "folic acid", "therapeutic_area_mesh": "Ovarian Neoplasms;Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated for the enhancement of 99mTc-etarfolatide single photon emission computed tomography (SPECT) image quality", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Endocyte Europe, B.V.", "european_commission_decision_date": "21/03/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "16/05/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/06/2014", "last_updated_date": "14/08/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neocepri" }, { "category": "Human", "name_of_medicine": "Vynfinit", "ema_product_number": "EMEA/H/C/002571", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Ovarian Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of platinum resistant ovarian cancer (PROC)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Endocyte Europe, B.V.", "european_commission_decision_date": "21/03/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "16/05/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/06/2014", "last_updated_date": "14/08/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vynfinit" }, { "category": "Human", "name_of_medicine": "Folcepri", "ema_product_number": "EMEA/H/C/002570", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "Etarfolatide", "therapeutic_area_mesh": "Ovarian Neoplasms;Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated for single photon emission computed tomography (SPECT) imaging", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Endocyte Europe, B.V.", "european_commission_decision_date": "21/03/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "16/05/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/06/2014", "last_updated_date": "14/08/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/folcepri" }, { "category": "Human", "name_of_medicine": "Revasc", "ema_product_number": "EMEA/H/C/000104", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IAIN/0031/G", "international_non_proprietary_name_common_name": "desirudin", "active_substance": "desirudin", "therapeutic_area_mesh": "Venous Thrombosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement surgery.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Canyon Pharmaceuticals Ltd.", "european_commission_decision_date": "23/01/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/07/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/07/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "23/01/2012", "last_updated_date": "29/07/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/revasc" }, { "category": "Human", "name_of_medicine": "Olanzapine Cipla (previously Olanzapine Neopharma)", "ema_product_number": "EMEA/H/C/000793", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/14", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cipla (EU) Limited", "european_commission_decision_date": "28/11/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "08/07/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "12", "first_published_date": "28/11/2013", "last_updated_date": "24/07/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/olanzapine-cipla" }, { "category": "Human", "name_of_medicine": "Issarlos", "ema_product_number": "EMEA/H/C/002756", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "strontium ranelate;colecalciferol", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "25/04/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/03/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/04/2014", "last_updated_date": "10/07/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/issarlos" }, { "category": "Human", "name_of_medicine": "Ditelos", "ema_product_number": "EMEA/H/C/002593", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "strontium ranelate;colecalciferol", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "25/04/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/03/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/04/2014", "last_updated_date": "10/07/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ditelos" }, { "category": "Human", "name_of_medicine": "Preotact", "ema_product_number": "EMEA/H/C/000659", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0022", "international_non_proprietary_name_common_name": "parathyroid hormone (rDNA)", "active_substance": "parathyroid hormone (rDNA)", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05AA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1). A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "NPS Pharma Holdings Limited", "european_commission_decision_date": "16/05/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/04/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "16/05/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "16/05/2014", "last_updated_date": "02/07/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/preotact" }, { "category": "Veterinary", "name_of_medicine": "Meloxivet", "ema_product_number": "EMEA/V/C/000124", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/0437", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QM01AC06", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Musculo-skeletal system", "therapeutic_indication": "Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly and Company Limited ", "european_commission_decision_date": "28/05/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "28/05/2014", "last_updated_date": "18/06/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/meloxivet" }, { "category": "Veterinary", "name_of_medicine": "Netvax", "ema_product_number": "EMEA/V/C/000134", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0006", "international_non_proprietary_name_common_name": "adjuvanted vaccine against necrotic enteritis of chickens due to Clostridium perfringens", "active_substance": "Clostridium-perfringens-type-A alpha toxoid", "therapeutic_area_mesh": "", "species_veterinary": "Chicken", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI01AB08", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves", "therapeutic_indication": "For the active immunisation of chickens to provide passive immunisation against necrotic enteritis to their progeny, during the laying period. To reduce mortality and the incidence and severity of lesions caused by Clostridium-perfringens-type-A-induced necrotic enteritis. Efficacy was demonstrated by challenge of chicks approximately three weeks after hatching. The onset of passive transfer of immunity: 6 weeks following completion of the vaccination procedure. The duration of passive transfer of immunity: 51 weeks following completion of the vaccination procedure.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "19/09/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/04/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "19/09/2013", "last_updated_date": "11/06/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/netvax" }, { "category": "Human", "name_of_medicine": "Viracept", "ema_product_number": "EMEA/H/C/000164", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0121", "international_non_proprietary_name_common_name": "nelfinavir", "active_substance": "nelfinavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Viracept is indicated in antiretroviral combination treatment of human-immunodeficiency-virus (HIV-1)-infected adults, adolescents and children of three years of age and older. In protease-inhibitor (PI)-experienced patients, the choice of nelfinavir should be based on individual viral resistance testing and treatment history.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration Ltd.", "european_commission_decision_date": "23/01/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/01/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "23/01/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "25", "first_published_date": "23/01/2013", "last_updated_date": "10/06/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/viracept" }, { "category": "Human", "name_of_medicine": "Heplisav", "ema_product_number": "EMEA/H/C/002603", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Hepatitis B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Indicated for active immunisation of adults against hepatitis B virus (HBV) infection", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dynavax International B.V.", "european_commission_decision_date": "21/02/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "10/02/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/02/2014", "last_updated_date": "26/05/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/heplisav" }, { "category": "Veterinary", "name_of_medicine": "Flexicam", "ema_product_number": "EMEA/V/C/000102", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0012", "international_non_proprietary_name_common_name": "meloxicam", "active_substance": "meloxicam", "therapeutic_area_mesh": "", "species_veterinary": "Dogs;Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QM01AC06", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Anti-inflammatory and anti-rheumatic products", "therapeutic_indication": "Oral suspension: Dogs:Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Solution for injection: Dogs:Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery. Cats:Reduction of postoperative pain after ovariohysterectomy and minor soft tissue surgery", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dechra Veterinary Products A/S", "european_commission_decision_date": "06/05/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/04/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "06/05/2014", "last_updated_date": "20/05/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/flexicam" }, { "category": "Human", "name_of_medicine": "Clopidogrel Teva Generics B.V.", "ema_product_number": "EMEA/H/C/002254", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0010/G", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrochloride)", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Acute Coronary Syndrome;Myocardial Infarction;Stroke", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "05/11/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/10/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "05/11/2013", "last_updated_date": "12/05/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-teva-generics-bv" }, { "category": "Human", "name_of_medicine": "Onduarp", "ema_product_number": "EMEA/H/C/002118", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/0236", "international_non_proprietary_name_common_name": "telmisartan;amlodipine", "active_substance": "telmisartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiovascular system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension in adults: Add on therapy Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine. Replacement therapy Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Onduarp containing the same component doses.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "17/02/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/11/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "17/02/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "17/02/2014", "last_updated_date": "02/04/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/onduarp" }, { "category": "Human", "name_of_medicine": "Leflunomide Teva", "ema_product_number": "EMEA/H/C/002356", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0011", "international_non_proprietary_name_common_name": "leflunomide", "active_substance": "leflunomide", "therapeutic_area_mesh": "Arthritis, Rheumatoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Leflunomide is indicated for the treatment of adult patients with active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD). Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "15/01/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/03/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "10/03/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "15/01/2014", "last_updated_date": "18/03/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/leflunomide-teva" }, { "category": "Human", "name_of_medicine": "Winfuran", "ema_product_number": "EMEA/H/C/002683", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Kidney Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V03AX02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of uraemic pruritus (UP)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Toray International U.K. Limited", "european_commission_decision_date": "20/12/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/01/2014", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/01/2014", "last_updated_date": "11/03/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/winfuran" }, { "category": "Human", "name_of_medicine": "Docetaxel Teva Pharma", "ema_product_number": "EMEA/H/C/002032", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/7/G", "international_non_proprietary_name_common_name": "docetaxel", "active_substance": "docetaxel", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Breast Neoplasms;Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Docetaxel Teva Pharma monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Non-small-cell lung cancer Docetaxel Teva Pharma is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Teva Pharma in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Teva Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "21/01/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/01/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "21/01/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "21/01/2014", "last_updated_date": "21/01/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/docetaxel-teva-pharma" }, { "category": "Human", "name_of_medicine": "Tritanrix HepB", "ema_product_number": "EMEA/H/C/000093", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0049", "international_non_proprietary_name_common_name": "diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)", "active_substance": "Diphtheria toxoid;hepatitis B surface antigen;Bordetella pertussis (inactivated);tetanus toxoid", "therapeutic_area_mesh": "Hepatitis B;Tetanus;Immunization;Whooping Cough;Diphtheria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07CA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from six weeks onwards (see section 4.2).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "01/01/2014", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/07/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/01/2014", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "01/01/2014", "last_updated_date": "07/01/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tritanrix-hepb" }, { "category": "Human", "name_of_medicine": "Clopidogrel ratiopharm", "ema_product_number": "EMEA/H/C/001173", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0016", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Archie Samuel s.r.o.", "european_commission_decision_date": "25/10/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "25/10/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "25/10/2013", "last_updated_date": "12/12/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-ratiopharm-0" }, { "category": "Human", "name_of_medicine": "Masican", "ema_product_number": "EMEA/H/C/002670", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "masitinib", "active_substance": "masitinib", "therapeutic_area_mesh": "Gastrointestinal Stromal Tumors", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Protein kinase inhibitors", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AB Science", "european_commission_decision_date": "22/11/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/03/2014", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "04/07/2014", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/11/2013", "last_updated_date": "22/11/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/masican" }, { "category": "Human", "name_of_medicine": "Rasitrio", "ema_product_number": "EMEA/H/C/002017", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0015", "international_non_proprietary_name_common_name": "aliskiren;amlodipine;hydrochlorothiazide", "active_substance": "aliskiren;amlodipine;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09XA54", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiovascular system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rasitrio is indicated for the treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently at the same dose level as in the combination.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd.", "european_commission_decision_date": "03/10/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/11/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "03/10/2013", "last_updated_date": "20/09/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rasitrio" }, { "category": "Human", "name_of_medicine": "IXinity", "ema_product_number": "EMEA/H/C/002349", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "trenonacog alfa;trenonacog alfa", "therapeutic_area_mesh": "Hemophilia B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B02BD12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of hemophilia B", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cangene Europe Limited", "european_commission_decision_date": "28/06/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/06/2013", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/06/2013", "last_updated_date": "18/09/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ixinity" }, { "category": "Human", "name_of_medicine": "Infanrix Penta", "ema_product_number": "EMEA/H/C/000295", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0067", "international_non_proprietary_name_common_name": "diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)", "active_substance": "Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin);poliovirus (inactivated) (type 1 (Mahoney strain), type 2 (MEF-1 strain), type 3 (Saukett strain));hepatitis B surface antigen", "therapeutic_area_mesh": "Hepatitis B;Tetanus;Immunization;Whooping Cough;Poliomyelitis;Diphtheria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07CA12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "31/08/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/10/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "30/05/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "31/08/2010", "last_updated_date": "23/08/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/infanrix-penta" }, { "category": "Human", "name_of_medicine": "Belviq", "ema_product_number": "EMEA/H/C/002597", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Obesity;Overweight", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A08AA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "As an adjunct to diet and exercise for weight control", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Arena Pharmaceutical Enterprises Limited", "european_commission_decision_date": "31/05/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "03/05/2013", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/05/2013", "last_updated_date": "20/08/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/belviq" }, { "category": "Human", "name_of_medicine": "Raxone", "ema_product_number": "EMEA/H/C/002425", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "idebenone", "active_substance": "idebenone", "therapeutic_area_mesh": "Eye Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06BX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Lebers Hereditary Optic Neuropathy", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Santhera Pharmaceuticals (Deutschland) GmbH", "european_commission_decision_date": "18/01/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "21/03/2013", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/04/2013", "last_updated_date": "06/08/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/raxone-0" }, { "category": "Human", "name_of_medicine": "OraNera", "ema_product_number": "EMEA/H/C/002443", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Corneal Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of limbal stem cell deficiency in adults", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CellSeed Europe Ltd", "european_commission_decision_date": "22/03/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "14/03/2013", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/03/2013", "last_updated_date": "30/07/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/oranera" }, { "category": "Human", "name_of_medicine": "Sepioglin", "ema_product_number": "EMEA/H/C/002021", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pioglitazone is indicated as second- or third-line treatment of type-2 diabetes mellitus as described below: as monotherapy: in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with: metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2-diabetes-mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4). After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vaia S.A.", "european_commission_decision_date": "06/06/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/03/2012", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "06/06/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "06/06/2013", "last_updated_date": "18/07/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sepioglin" }, { "category": "Veterinary", "name_of_medicine": "Ibaflin", "ema_product_number": "EMEA/V/C/000052", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0019", "international_non_proprietary_name_common_name": "ibafloxacin", "active_substance": "ibafloxacin", "therapeutic_area_mesh": "", "species_veterinary": "Dogs;Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QJ01MA96", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "Dogs: Ibaflin is indicated for the treatment of the following conditions in dogs: dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible strains of Staphylococci, Escherichia coli and Proteus mirabilis; acute, uncomplicated urinary-tract infections, caused by susceptible strains of Staphylococci, Proteus species, Enterobacter spp., E. coli and Klebsiella spp.; respiratory-tract infections (upper tract) caused by susceptible strains of Staphylococci, E. coli, and Klebsiella spp. Ibaflin gel is indicated in dogs for the treatment of the following conditions: dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli and P. mirabilis. Cats: Ibaflin gel is indicated in cats for treatment of the following conditions: dermal infections (soft-tissue infections - wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli, Proteus spp. and Pasteurella spp.; upper respiratory-tract infections caused by susceptible pathogens such as Staphylococcus spp., E. coli, Klebsiella spp. and Pasteurella spp.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "26/05/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/06/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "26/05/2010", "last_updated_date": "10/07/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/ibaflin" }, { "category": "Human", "name_of_medicine": "Daronrix", "ema_product_number": "EMEA/H/C/000706", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pandemic influenza vaccine (whole virion, inactivated, adjuvanted)", "active_substance": "whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "21/03/2007", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "24/06/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/03/2007", "last_updated_date": "02/07/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/daronrix" }, { "category": "Human", "name_of_medicine": "Omontys", "ema_product_number": "EMEA/H/C/002600", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "peginesatide", "therapeutic_area_mesh": "Anemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of symptomatic anaemia associated with chronic kidney disease (CKD)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Global Research and Development Centre (Europe)", "european_commission_decision_date": "28/06/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "28/06/2013", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/06/2013", "last_updated_date": "28/06/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/omontys" }, { "category": "Human", "name_of_medicine": "Kynamro", "ema_product_number": "EMEA/H/C/002429", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "mipomersen sodium", "active_substance": "mipomersen sodium", "therapeutic_area_mesh": "Hypercholesterolemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AX11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiovascular system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of cholesterol and hypercholesterolaemia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Genzyme Europe BV", "european_commission_decision_date": "14/12/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/03/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "29/05/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/12/2012", "last_updated_date": "17/06/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kynamro" }, { "category": "Human", "name_of_medicine": "Qsiva", "ema_product_number": "EMEA/H/C/002350", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "phentermine;topiramate", "active_substance": "phentermine;topiramate", "therapeutic_area_mesh": "Obesity", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vivus BV", "european_commission_decision_date": "14/05/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "21/02/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "14/05/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/05/2013", "last_updated_date": "13/06/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/qsiva" }, { "category": "Veterinary", "name_of_medicine": "Nobivac Piro", "ema_product_number": "EMEA/V/C/000084", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0006", "international_non_proprietary_name_common_name": "vaccine against babesiosis in dogs", "active_substance": "babesia canis, inactivated;babesia rossi, inactivated", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI07AO", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for canidae", "therapeutic_indication": "For active immunisation of dogs of six months of age or older against Babesia canis to reduce the severity of clinical signs associated with acute babesiosis (B. canis) and anaemia as measured by packed cell volume. Onset of immunity: Three weeks after the basic vaccination course. Duration of immunity: Six months after the last (re-)vaccination.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "22/05/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/09/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "22/05/2013", "last_updated_date": "30/05/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobivac-piro" }, { "category": "Human", "name_of_medicine": "Fanaptum", "ema_product_number": "EMEA/H/C/002371", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "iloperidone", "active_substance": "iloperidone", "therapeutic_area_mesh": "Schizophrenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Nervous system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of schizophrenia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Vanda Pharmaceuticals Ltd", "european_commission_decision_date": "14/12/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/03/2013", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/03/2013", "last_updated_date": "17/05/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fanaptum" }, { "category": "Human", "name_of_medicine": "Trevaclyn", "ema_product_number": "EMEA/H/C/000897", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A20/0038", "international_non_proprietary_name_common_name": "laropiprant;nicotinic acid", "active_substance": "laropiprant;nicotinic acid", "therapeutic_area_mesh": "Dyslipidemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AD52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trevaclyn is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (LDL) cholesterol and triglycerides and low high-density-lipoprotein (HDL) cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial). Trevaclyn should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-A (HMG-CoA)-reductase inhibitors (statins), when the cholesterol-lowering effect of HMG-CoA-reductase-inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA-reductase inhibitors are considered inappropriate or not tolerated. Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Trevaclyn.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp Dohme Ltd", "european_commission_decision_date": "10/04/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/07/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "10/04/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "10/04/2013", "last_updated_date": "16/05/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trevaclyn" }, { "category": "Human", "name_of_medicine": "Pelzont", "ema_product_number": "EMEA/H/C/000903", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A20/0038", "international_non_proprietary_name_common_name": "laropiprant;nicotinic acid", "active_substance": "laropiprant;nicotinic acid", "therapeutic_area_mesh": "Dyslipidemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AD52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pelzont is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (LDL) cholesterol and triglycerides and low high-density-lipoprotein (HDL)cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial). Pelzont should be used in patients in combination with 3-hydroxy-3-methylglutaryl-coenzyme-A (HMG-CoA)-reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA-reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA-reductase inhibitors are considered inappropriate or not tolerated. Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Pelzont.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp Dohme Ltd", "european_commission_decision_date": "10/04/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/07/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "10/04/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "10/04/2013", "last_updated_date": "16/05/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pelzont" }, { "category": "Human", "name_of_medicine": "Tredaptive", "ema_product_number": "EMEA/H/C/000889", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A20/0038", "international_non_proprietary_name_common_name": "laropiprant;nicotinic acid", "active_substance": "laropiprant;nicotinic acid", "therapeutic_area_mesh": "Dyslipidemias", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C10AD52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Lipid modifying agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tredaptive is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (LDL) cholesterol and triglycerides and low high-density-lipoprotein (HDL) cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial). Tredaptive should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-A (HMG-CoA)-reductase inhibitors (statins), when the cholesterol-lowering effect of HMG-CoA-reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA-reductase inhibitors are considered inappropriate or not tolerated. Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Tredaptive.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp Dohme Ltd.", "european_commission_decision_date": "10/04/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/07/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "10/04/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "10/04/2013", "last_updated_date": "16/05/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tredaptive" }, { "category": "Human", "name_of_medicine": "Hyalograft C autograft", "ema_product_number": "EMEA/H/C/002657", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "Not yet assigned", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Repairing defects in the cartilage of the femoral condyles and trochlea (the end of the thigh bone that forms part of the knee) caused by sudden or repetitive trauma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Anika Therapeutics S.r.l.", "european_commission_decision_date": "27/02/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "14/01/2013", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/02/2013", "last_updated_date": "14/05/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hyalograft-c-autograft" }, { "category": "Human", "name_of_medicine": "Bondenza (previously Ibandronic Acid Roche)", "ema_product_number": "EMEA/H/C/000502", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0034", "international_non_proprietary_name_common_name": "ibandronic acid", "active_substance": "ibandronic acid", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of osteoporosis in post-menopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated. Efficacy on femoral-neck fractures has not been established.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration Ltd.", "european_commission_decision_date": "15/11/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/02/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "14/02/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "16", "first_published_date": "15/11/2012", "last_updated_date": "13/05/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bondenza" }, { "category": "Human", "name_of_medicine": "Ribavirin BioPartners", "ema_product_number": "EMEA/H/C/001184", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0003/G", "international_non_proprietary_name_common_name": "ribavirin", "active_substance": "ribavirin", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ribavirin BioPartners is indicated for the treatment of chronic hepatitis-C-virus (HCV) infection in adults, children three years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used. There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b). Naïve patients Adult patients Ribavirin BioPartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid (HCV-RNA) (see section 4.4) Children three years of age and older and adolescents Ribavirin BioPartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children three years of age and older and adolescents, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4). Previous-treatment-failure patients Adult patients Ribavirin BioPartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alfa monotherapy but who have subsequently relapsed (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioPartners GmbH", "european_commission_decision_date": "21/11/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/04/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/04/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "21/11/2012", "last_updated_date": "06/05/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ribavirin-biopartners" }, { "category": "Human", "name_of_medicine": "Possia", "ema_product_number": "EMEA/H/C/002303", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/0292", "international_non_proprietary_name_common_name": "ticagrelor", "active_substance": "ticagrelor", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Acute Coronary Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC24", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Possia, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non-ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca AB", "european_commission_decision_date": "24/10/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/12/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/03/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "24/10/2012", "last_updated_date": "22/04/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/possia" }, { "category": "Human", "name_of_medicine": "Ruvise", "ema_product_number": "EMEA/H/C/002551", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "imatinib", "active_substance": "imatinib", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd", "european_commission_decision_date": "22/02/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "21/02/2013", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "22/02/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/02/2013", "last_updated_date": "10/04/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ruvise" }, { "category": "Human", "name_of_medicine": "Memantine FGK", "ema_product_number": "EMEA/H/C/002687", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "memantine", "active_substance": "memantine", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Alzheimers disease", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "FGK Representative Service GmbH", "european_commission_decision_date": "18/01/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "18/12/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/01/2013", "last_updated_date": "10/04/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/memantine-fgk" }, { "category": "Human", "name_of_medicine": "Labazenit", "ema_product_number": "EMEA/H/C/002201", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "budesonide;salmeterol", "active_substance": "Budesonide;salmeterol", "therapeutic_area_mesh": "Asthma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of asthma", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoires SMB S.A.  ", "european_commission_decision_date": "22/03/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/06/2013", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "06/09/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/03/2013", "last_updated_date": "22/03/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/labazenit" }, { "category": "Human", "name_of_medicine": "Istodax", "ema_product_number": "EMEA/H/C/002122", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "romidepsin", "active_substance": "romidepsin", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX39", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of peripheral T-cell lymphoma (PTCL)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celgene Europe Ltd.", "european_commission_decision_date": "20/07/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/11/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "12/02/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/07/2012", "last_updated_date": "14/03/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/istodax" }, { "category": "Human", "name_of_medicine": "Acrescent", "ema_product_number": "EMEA/H/C/002424", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "memantine hydrochloride;donepezil hydrochloride", "active_substance": "memantine hydrochloride;donepezil hydrochloride", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06D", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Alzheimers disease", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "H. Lundbeck A/S", "european_commission_decision_date": "18/10/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "20/02/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/10/2012", "last_updated_date": "11/03/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/acrescent" }, { "category": "Human", "name_of_medicine": "Balaxur", "ema_product_number": "EMEA/H/C/002708", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "memantine hydrochloride;donepezil hydrochloride", "active_substance": "memantine hydrochloride;donepezil hydrochloride", "therapeutic_area_mesh": "Alzheimer Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DA52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merz Pharmaceuticals GmbH", "european_commission_decision_date": "18/10/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "18/10/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "20/02/2013", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/10/2012", "last_updated_date": "11/03/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/balaxur" }, { "category": "Human", "name_of_medicine": "Riprazo", "ema_product_number": "EMEA/H/C/000853", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IG/0209/G", "international_non_proprietary_name_common_name": "aliskiren", "active_substance": "aliskiren", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09XA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd.", "european_commission_decision_date": "17/08/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "24/01/2013", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "17/08/2012", "last_updated_date": "01/03/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/riprazo" }, { "category": "Human", "name_of_medicine": "Jenzyl", "ema_product_number": "EMEA/H/C/002259", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "TReament of metastatic soft tissue sarcoma or bone sarcoma", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp and Dohme Ltd.", "european_commission_decision_date": "14/12/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "27/11/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/12/2012", "last_updated_date": "18/02/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jenzyl" }, { "category": "Human", "name_of_medicine": "Loulla", "ema_product_number": "EMEA/H/C/002501", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "mercaptopurine", "active_substance": "", "therapeutic_area_mesh": "Leukemia, Lymphoid", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of acute lymphatic leukemia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Only For Children Pharmaceuticals", "european_commission_decision_date": "18/01/2013", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "19/12/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/01/2013", "last_updated_date": "18/01/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/loulla" }, { "category": "Human", "name_of_medicine": "Duloxetine Boehringer Ingelheim", "ema_product_number": "EMEA/H/C/001007", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "P46/008", "international_non_proprietary_name_common_name": "duloxetine", "active_substance": "duloxetine", "therapeutic_area_mesh": "Diabetic Neuropathies", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06AX21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetic peripheral neuropathic pain in adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "07/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/10/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "26/05/2010", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "07/12/2009", "last_updated_date": "17/01/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duloxetine-boehringer-ingelheim" }, { "category": "Human", "name_of_medicine": "Solumarv", "ema_product_number": "EMEA/H/C/002506", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "insulin human", "active_substance": "insulin human", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of diabetes mellitus", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Marvel Life Sciences Ltd.", "european_commission_decision_date": "14/12/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "15/11/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/12/2012", "last_updated_date": "14/12/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/solumarv" }, { "category": "Human", "name_of_medicine": "Isomarv medium", "ema_product_number": "EMEA/H/C/002610", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "insulin human", "active_substance": "insulin human", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of diabetes mellitus", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Marvel Life Sciences Ltd.", "european_commission_decision_date": "14/12/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "15/11/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/12/2012", "last_updated_date": "14/12/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/isomarv-medium" }, { "category": "Human", "name_of_medicine": "Combimarv", "ema_product_number": "EMEA/H/C/002609", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "insulin human", "active_substance": "insulin human", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Marvel Life Sciences Ltd.", "european_commission_decision_date": "14/12/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "15/11/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/12/2012", "last_updated_date": "14/12/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/combimarv" }, { "category": "Human", "name_of_medicine": "Elelyso", "ema_product_number": "EMEA/H/C/002250", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "taliglucerase alfa", "active_substance": "taliglucerase alfa", "therapeutic_area_mesh": "Gaucher Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A16AB11", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of Gaucher disease", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Ltd.   ", "european_commission_decision_date": "29/10/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "03/07/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "25/10/2012", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/10/2012", "last_updated_date": "23/11/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/elelyso" }, { "category": "Human", "name_of_medicine": "Rilonacept Regeneron (previously Arcalyst)", "ema_product_number": "EMEA/H/C/001047", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "S/0006", "international_non_proprietary_name_common_name": "rilonacept", "active_substance": "rilonacept", "therapeutic_area_mesh": "Cryopyrin-Associated Periodic Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rilonacept Regeneron is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) with severe symptoms, including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), in adults and children aged 12 years and older.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Regeneron UK Limited", "european_commission_decision_date": "28/06/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "24/10/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "28/06/2012", "last_updated_date": "30/10/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rilonacept-regeneron" }, { "category": "Human", "name_of_medicine": "Imprida HCT", "ema_product_number": "EMEA/H/C/001161", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "WS/0250/G", "international_non_proprietary_name_common_name": "amlodipine;valsartan;hydrochlorothiazide", "active_substance": "amlodipine;valsartan;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Angiotensin II antagonists, plain;Angiotensin II antagonists, combinations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd.", "european_commission_decision_date": "20/10/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/10/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "20/10/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "20/10/2012", "last_updated_date": "22/10/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imprida-hct" }, { "category": "Human", "name_of_medicine": "Zerene", "ema_product_number": "EMEA/H/C/000228", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0023", "international_non_proprietary_name_common_name": "zaleplon", "active_substance": "zaleplon", "therapeutic_area_mesh": "Sleep Initiation and Maintenance Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05CF03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Meda AB", "european_commission_decision_date": "23/08/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "12/03/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "23/08/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "23/08/2012", "last_updated_date": "15/10/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zerene" }, { "category": "Human", "name_of_medicine": "Rivastigmine Teva", "ema_product_number": "EMEA/H/C/001044", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0008/G", "international_non_proprietary_name_common_name": "rivastigmine", "active_substance": "rivastigmine", "therapeutic_area_mesh": "Dementia;Alzheimer Disease;Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anticholinesterases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "10/09/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/04/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "10/09/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "10/09/2012", "last_updated_date": "27/09/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rivastigmine-teva" }, { "category": "Human", "name_of_medicine": "SecreFlo", "ema_product_number": "EMEA/H/C/002027", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Repligen Europe Limited", "european_commission_decision_date": "24/09/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "15/08/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/09/2012", "last_updated_date": "24/09/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/secreflo" }, { "category": "Human", "name_of_medicine": "Riprazo HCT", "ema_product_number": "EMEA/H/C/002420", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "aliskiren;hydrochlorothiazide", "active_substance": "aliskiren;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09XA52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension in adults. Riprazo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Rirpozo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd.", "european_commission_decision_date": "30/08/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/04/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "30/08/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/08/2012", "last_updated_date": "20/09/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/riprazo-hct" }, { "category": "Human", "name_of_medicine": "Sprimeo HCT", "ema_product_number": "EMEA/H/C/002421", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "aliskiren;hydrochlorothiazide", "active_substance": "aliskiren;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09XA52", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension in adults. Sprimeo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Sprimeo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd.", "european_commission_decision_date": "06/07/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/06/2011", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "06/07/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/07/2012", "last_updated_date": "28/08/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sprimeo-hct" }, { "category": "Human", "name_of_medicine": "Exalief", "ema_product_number": "EMEA/H/C/000987", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0025", "international_non_proprietary_name_common_name": "eslicarbazepine acetate", "active_substance": "eslicarbazepine acetate", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N03AF04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiepileptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BIAL - Portela Ca, S.A.", "european_commission_decision_date": "21/04/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/04/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "24/07/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "21/04/2012", "last_updated_date": "16/08/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exalief" }, { "category": "Human", "name_of_medicine": "Hexavac", "ema_product_number": "EMEA/H/C/000298", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted", "active_substance": "purified diphtheria toxoid;purified tetanus toxoid;purified pertussis toxoid;purified pertussis filamentous haemagglutinin;hepatitis B surface antigen;Inactivated Type 1 Poliovirus (Mahoney);Inactivated Type 3 Poliovirus (Saukett);Haemophilus influenzae type b polysaccharide", "therapeutic_area_mesh": "Hepatitis B;Tetanus;Immunization;Meningitis, Haemophilus;Whooping Cough;Poliomyelitis;Diphtheria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07CA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Pasteur MSD, SNC", "european_commission_decision_date": "28/06/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/10/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/06/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/06/2012", "last_updated_date": "16/08/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hexavac" }, { "category": "Human", "name_of_medicine": "Regranex", "ema_product_number": "EMEA/H/C/000212", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0037/G", "international_non_proprietary_name_common_name": "becaplermin", "active_substance": "becaplermin", "therapeutic_area_mesh": "Wound Healing;Skin Ulcer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D03AX06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Preparations for treatment of wounds and ulcers", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Regranex is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "11/10/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/03/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "16/07/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "11/10/2010", "last_updated_date": "15/08/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/regranex" }, { "category": "Human", "name_of_medicine": "MabCampath", "ema_product_number": "EMEA/H/C/000353", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0055", "international_non_proprietary_name_common_name": "alemtuzumab", "active_substance": "alemtuzumab", "therapeutic_area_mesh": "Leukemia, Lymphocytic, Chronic, B-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination chemotherapy is not appropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Genzyme Europe B.V.", "european_commission_decision_date": "06/07/2001", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/07/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "08/08/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "06/07/2001", "last_updated_date": "15/08/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mabcampath" }, { "category": "Veterinary", "name_of_medicine": "Gonazon", "ema_product_number": "EMEA/V/C/000075", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0005", "international_non_proprietary_name_common_name": "azagly-nafarelin", "active_substance": "azagly-nafarelin", "therapeutic_area_mesh": "", "species_veterinary": "Dogs;Salmonidae (Salmonid fish)", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QH01CA", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Pituitary and hypothalamic hormones and analogues", "therapeutic_indication": "Female salmonid fish such as Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), brown trout (Salmo trutta) and Arctic charr (Salvelinus alpinus) Induction and synchronisation of ovulation for the production of eyed-eggs and fry. Dogs (bitches) Prevention of gonadal function in bitches via long term blockade of gonadotrophin synthesis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "22/07/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/07/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "22/07/2009", "last_updated_date": "15/08/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/gonazon" }, { "category": "Human", "name_of_medicine": "Valtropin", "ema_product_number": "EMEA/H/C/000602", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A20/08", "international_non_proprietary_name_common_name": "somatropin", "active_substance": "somatropin", "therapeutic_area_mesh": "Turner Syndrome;Dwarfism, Pituitary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H01AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Pituitary and hypothalamic hormones and analogues", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Paediatric poulation Long-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone. Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis. Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency. Adult patients Replacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. In patients with childhood-onset isolated growth hormone deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like growth factor-1 (IGF-1) concentrations (< 2 standard deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioPartners GmbH", "european_commission_decision_date": "10/05/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/04/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "10/05/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "10/05/2012", "last_updated_date": "14/08/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/valtropin" }, { "category": "Human", "name_of_medicine": "Teslascan", "ema_product_number": "EMEA/H/C/000137", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0016", "international_non_proprietary_name_common_name": "mangafodipir", "active_substance": "mangafodipir trisodium", "therapeutic_area_mesh": "Magnetic Resonance Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V08CA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Contrast media", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Contrast medium for diagnostic magnetic resonance imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas. As an adjunct to MRI to aid in the investigation of focal pancreatic lesions.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GE Healthcare AS", "european_commission_decision_date": "23/10/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/05/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "21/06/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "23/10/2009", "last_updated_date": "02/08/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/teslascan" }, { "category": "Human", "name_of_medicine": "Refludan", "ema_product_number": "EMEA/H/C/000122", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0038", "international_non_proprietary_name_common_name": "lepirudin", "active_substance": "lepirudin", "therapeutic_area_mesh": "Thromboembolism;Thrombocytopenia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AE02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Anticoagulation in adult patients with heparin-induced thrombocytopenia type II and thromboembolic disease mandating parenteral antithrombotic therapy. The diagnosis should be confirmed by the heparin-induced platelet activation assay or an equivalent test.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celgene Europe Ltd.", "european_commission_decision_date": "24/04/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/03/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "24/04/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "15", "first_published_date": "24/04/2012", "last_updated_date": "27/07/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/refludan" }, { "category": "Human", "name_of_medicine": "Clopidogrel Acino Pharma GmbH", "ema_product_number": "EMEA/H/C/001175", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A20/04", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Acino Pharma GmbH", "european_commission_decision_date": "13/02/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/02/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "13/02/2012", "last_updated_date": "26/07/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-acino-pharma-gmbh" }, { "category": "Human", "name_of_medicine": "Clopidogrel Acino Pharma", "ema_product_number": "EMEA/H/C/001172", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A20/0004", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Acino Pharma GmbH", "european_commission_decision_date": "09/02/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/02/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "09/02/2012", "last_updated_date": "26/07/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-acino-pharma" }, { "category": "Human", "name_of_medicine": "Clopidogrel Hexal", "ema_product_number": "EMEA/H/C/001139", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A20/0006", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Acute Coronary Syndrome;Myocardial Infarction;Stroke", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease; patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Acino Pharma GmbH", "european_commission_decision_date": "09/02/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/02/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "09/02/2012", "last_updated_date": "26/07/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-hexal" }, { "category": "Human", "name_of_medicine": "Sprimeo", "ema_product_number": "EMEA/H/C/000851", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0039", "international_non_proprietary_name_common_name": "aliskiren", "active_substance": "aliskiren", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09XA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd.", "european_commission_decision_date": "04/07/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "04/07/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "04/07/2012", "last_updated_date": "23/07/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sprimeo" }, { "category": "Human", "name_of_medicine": "Mulsevo", "ema_product_number": "EMEA/H/C/002516", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "semuloparin sodium", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "  prevention of venous thromboembolism    ", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi-aventis groupe", "european_commission_decision_date": "20/07/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "05/07/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/07/2012", "last_updated_date": "20/07/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mulsevo" }, { "category": "Human", "name_of_medicine": "Egrifta", "ema_product_number": "EMEA/H/C/002427", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "tesamorelin", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of excess abdominal fat in HIV-infected patients with lipodystrophy", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ferrer Internacional S.A.", "european_commission_decision_date": "18/07/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "21/06/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/07/2012", "last_updated_date": "18/07/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/egrifta" }, { "category": "Human", "name_of_medicine": "Folotyn", "ema_product_number": "EMEA/H/C/002096", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "pralatrexate", "active_substance": "pralatrexate", "therapeutic_area_mesh": "Lymphoma, T-Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of peripheral T-cell lymphoma", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Allos Therapeutics Ltd", "european_commission_decision_date": "20/01/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/04/2012", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "21/06/2012", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/01/2012", "last_updated_date": "11/07/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/folotyn" }, { "category": "Human", "name_of_medicine": "Pioglitazone Teva Generics", "ema_product_number": "EMEA/H/C/002448", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone hydrochloride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Alimentary tract and metabolism", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of type 2 diabetes mellitus", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "23/09/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "26/01/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/04/2012", "last_updated_date": "03/07/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pioglitazone-teva-generics" }, { "category": "Veterinary", "name_of_medicine": "Oxapex", "ema_product_number": "EMEA/V/C/002342", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "New A Innovation (NL) Limited B.V.", "european_commission_decision_date": "25/06/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/03/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/06/2012", "last_updated_date": "25/06/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/oxapex-0" }, { "category": "Human", "name_of_medicine": "Fablyn", "ema_product_number": "EMEA/H/C/000977", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0003", "international_non_proprietary_name_common_name": "lasofoxifene", "active_substance": "Lasofoxifene tartrate", "therapeutic_area_mesh": "Osteoporosis, Postmenopausal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fablyn is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1). When determining the choice of Fablyn or other therapies, including oestrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dr. Friedrich Eberth Arzneimittel GmbH", "european_commission_decision_date": "27/02/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/02/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/02/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "27/02/2012", "last_updated_date": "21/06/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fablyn" }, { "category": "Human", "name_of_medicine": "Intrinsa", "ema_product_number": "EMEA/H/C/000634", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0018", "international_non_proprietary_name_common_name": "testosterone", "active_substance": "testosterone", "therapeutic_area_mesh": "Sexual Dysfunctions, Psychological", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03BA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Warner Chilcott UK Ltd.", "european_commission_decision_date": "25/05/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/07/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "25/05/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "25/05/2012", "last_updated_date": "18/06/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/intrinsa" }, { "category": "Human", "name_of_medicine": "Docefrez", "ema_product_number": "EMEA/H/C/001074", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0001", "international_non_proprietary_name_common_name": "docetaxel", "active_substance": "docetaxel", "therapeutic_area_mesh": "Stomach Neoplasms;Adenoma;Breast Neoplasms;Carcinoma, Non-Small-Cell Lung;Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Breast cancer Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small cell lung cancer Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "25/05/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/05/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "25/05/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "25/05/2012", "last_updated_date": "14/06/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/docefrez" }, { "category": "Veterinary", "name_of_medicine": "Zubrin", "ema_product_number": "EMEA/V/C/000057", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0032", "international_non_proprietary_name_common_name": "tepoxalin", "active_substance": "tepoxalin", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QM01AE92", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Musculo-skeletal system", "therapeutic_indication": "Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "02/02/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "13/03/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "02/02/2012", "last_updated_date": "08/05/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/zubrin" }, { "category": "Veterinary", "name_of_medicine": "Poulvac Flufend H5N3 RG", "ema_product_number": "EMEA/V/C/000117", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0010", "international_non_proprietary_name_common_name": "recombinant inactivated avian influenza virus", "active_substance": "recombinant inactivated avian influenza virus", "therapeutic_area_mesh": "", "species_veterinary": "Chicken;Ducks", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI01AA23", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals", "therapeutic_indication": "For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5. Chickens:Reduction of mortality and virus excretion after challenge.Onset of immunity: 3 weeks after the second injection.Duration of immunity in chickens has not been established yet. Ducks: Reduction of clinical signs and virus excretion after challenge.Onset of immunity: 3 weeks after the second injection.Duration of immunity in ducks : 14 weeks after the second injection.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "30/03/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/09/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "30/03/2012", "last_updated_date": "07/05/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/poulvac-flufend-h5n3-rg" }, { "category": "Human", "name_of_medicine": "PhotoBarr", "ema_product_number": "EMEA/H/C/000493", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0027", "international_non_proprietary_name_common_name": "porfimer sodium", "active_substance": "porfimer sodium", "therapeutic_area_mesh": "Barrett Esophagus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Photodynamic therapy (PDT) with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pinnacle Biologics B.V. ", "european_commission_decision_date": "20/04/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/03/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "20/04/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "20/04/2012", "last_updated_date": "07/05/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/photobarr" }, { "category": "Human", "name_of_medicine": "Pioglitazone ratiopharm GmbH", "ema_product_number": "EMEA/H/C/002369", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ratiopharm GmbH", "european_commission_decision_date": "22/07/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "03/02/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/04/2012", "last_updated_date": "30/04/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pioglitazone-ratiopharm-gmbh" }, { "category": "Human", "name_of_medicine": "Pioglitazone ratiopharm", "ema_product_number": "EMEA/H/C/002260", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ratiopharm GmbH", "european_commission_decision_date": "22/07/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "03/02/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/04/2012", "last_updated_date": "30/04/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pioglitazone-ratiopharm" }, { "category": "Human", "name_of_medicine": "Pioglitazone ratio", "ema_product_number": "EMEA/H/C/002370", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "pioglitazone", "active_substance": "pioglitazone", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ratiopharm GmbH", "european_commission_decision_date": "22/07/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "03/02/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/04/2012", "last_updated_date": "30/04/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pioglitazone-ratio" }, { "category": "Veterinary", "name_of_medicine": "Paccal Vet", "ema_product_number": "EMEA/V/C/002237", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "paclitaxel", "active_substance": "paclitaxel", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QL01CD01", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS", "therapeutic_indication": "Treatment of non-resectable grade II or III mast cell tumours in dogs.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Oasmia Pharmaceutical AB", "european_commission_decision_date": "25/04/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "02/03/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/04/2012", "last_updated_date": "25/04/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/paccal-vet" }, { "category": "Human", "name_of_medicine": "Fluad Paediatric", "ema_product_number": "EMEA/H/C/002299", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunization against influenza", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Vaccines and Diagnostics S.r.l.", "european_commission_decision_date": "21/02/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "10/02/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/02/2012", "last_updated_date": "24/04/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fluad-paediatric" }, { "category": "Human", "name_of_medicine": "Livensa", "ema_product_number": "EMEA/H/C/000630", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0016", "international_non_proprietary_name_common_name": "testosterone", "active_substance": "testosterone", "therapeutic_area_mesh": "Sexual Dysfunctions, Psychological", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03BA03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Warner Chilcott  Deutschland GmbH", "european_commission_decision_date": "18/07/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/07/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/03/2012", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "18/07/2011", "last_updated_date": "16/04/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/livensa" }, { "category": "Human", "name_of_medicine": "Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals", "ema_product_number": "EMEA/H/C/001015", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0013", "international_non_proprietary_name_common_name": "prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)", "active_substance": "split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Active immunisation against H5N1 subtype of Influenza A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1). Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "03/10/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/09/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "03/11/2011", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "03/10/2011", "last_updated_date": "21/03/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prepandemic-influenza-vaccine-h5n1-split-virion-inactivated-adjuvanted-glaxosmithkline-biologicals" }, { "category": "Human", "name_of_medicine": "Megestrol Alkermes", "ema_product_number": "EMEA/H/C/002177", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Alkermes Pharma Ireland Ltd.", "european_commission_decision_date": "20/03/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "06/03/2012", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/03/2012", "last_updated_date": "01/01/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/megestrol-alkermes" }, { "category": "Human", "name_of_medicine": "Xigris", "ema_product_number": "EMEA/H/C/000396", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "S/0029", "international_non_proprietary_name_common_name": "drotrecogin alfa (activated)", "active_substance": "drotrecogin alfa (activated)", "therapeutic_area_mesh": "Sepsis;Multiple Organ Failure", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AD10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Xigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The use of Xigris should be considered mainly in situations when therapy can be started within 24 hours after the onset of organ failure (for further information see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "28/11/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/11/2011", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "28/11/2011", "last_updated_date": "21/02/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xigris" }, { "category": "Human", "name_of_medicine": "Sumatriptan Galpharm", "ema_product_number": "EMEA/H/C/002140", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "sumatriptan", "active_substance": "sumatriptan succinate", "therapeutic_area_mesh": "Migraine Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Galpharm Healthcare Ltd.", "european_commission_decision_date": "09/02/2012", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "17/11/2011", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "09/02/2012", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "09/02/2012", "last_updated_date": "16/02/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sumatriptan-galpharm" }, { "category": "Human", "name_of_medicine": "Kalbitor", "ema_product_number": "EMEA/H/C/002200", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dyax s.a.", "european_commission_decision_date": "23/11/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "11/11/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/11/2011", "last_updated_date": "23/11/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kalbitor" }, { "category": "Human", "name_of_medicine": "Janacti", "ema_product_number": "EMEA/H/C/002394", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp Dohme Ltd.", "european_commission_decision_date": "22/11/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "07/11/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/11/2011", "last_updated_date": "22/11/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/janacti" }, { "category": "Human", "name_of_medicine": "Desloratadine Krka", "ema_product_number": "EMEA/H/C/002461", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "desloratadine", "active_substance": "desloratadine", "therapeutic_area_mesh": "Rhinitis, Allergic, Perennial;Rhinitis, Allergic, Seasonal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R06AX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Respiratory system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Relief of symptoms of allergic rhinitis and urticaria", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Krka, d.d., Novo mesto", "european_commission_decision_date": "23/09/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "14/10/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/11/2011", "last_updated_date": "17/11/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/desloratadine-krka" }, { "category": "Human", "name_of_medicine": "Ablavar (previously Vasovist)", "ema_product_number": "EMEA/H/C/000601", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0020", "international_non_proprietary_name_common_name": "gadofosveset trisodium", "active_substance": "gadofosveset trisodium", "therapeutic_area_mesh": "Magnetic Resonance Angiography", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V08CA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Contrast media", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only. Ablavar is indicated for contrast-enhanced magnetic resonance angiography (CE-MRA) for visualisation of abdominal or limb vessels in adults only, with suspected or known vascular disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "TMC Pharma Services Ltd.", "european_commission_decision_date": "15/05/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/10/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "18/10/2011", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "15/05/2011", "last_updated_date": "14/11/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ablavar" }, { "category": "Human", "name_of_medicine": "Clopidogrel Sandoz", "ema_product_number": "EMEA/H/C/001174", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A20/0007", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Stroke;Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Acino Pharma GmbH", "european_commission_decision_date": "16/09/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/09/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "31/03/2011", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "16/09/2010", "last_updated_date": "26/10/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-sandoz" }, { "category": "Human", "name_of_medicine": "Arepanrix", "ema_product_number": "EMEA/H/C/001201", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0005/G", "international_non_proprietary_name_common_name": "pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)", "active_substance": "split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs.", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Influenza vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "13/08/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/03/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/12/2010", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "13/08/2010", "last_updated_date": "25/10/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/arepanrix" }, { "category": "Human", "name_of_medicine": "Luveniq", "ema_product_number": "EMEA/H/C/002069", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "voclosporin", "therapeutic_area_mesh": "Uveitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AD03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic and immunomodulating agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "treatment of non-infectious uveitis", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Lux Biosciences GmbH", "european_commission_decision_date": "24/06/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/10/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/10/2011", "last_updated_date": "24/10/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/luveniq" }, { "category": "Human", "name_of_medicine": "Alisade", "ema_product_number": "EMEA/H/C/001019", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0007", "international_non_proprietary_name_common_name": "fluticasone furoate", "active_substance": "fluticasone furoate", "therapeutic_area_mesh": "Rhinitis, Allergic, Perennial;Rhinitis, Allergic, Seasonal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R01AD12", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Nasal preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Glaxo Group Ltd.", "european_commission_decision_date": "17/02/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "06/10/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/10/2011", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "17/02/2010", "last_updated_date": "18/10/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alisade" }, { "category": "Human", "name_of_medicine": "Doxorubicin SUN", "ema_product_number": "EMEA/H/C/002049", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "doxorubicin", "active_substance": "doxorubicin hydrochloride", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "13/09/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/07/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/09/2011", "last_updated_date": "26/09/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/doxorubicin-sun" }, { "category": "Veterinary", "name_of_medicine": "Yarvitan", "ema_product_number": "EMEA/V/C/000113", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0003", "international_non_proprietary_name_common_name": "mitratapide", "active_substance": "mitratapide", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QA08AB90", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antiobesity preparations, excl. diet products", "therapeutic_indication": "As an aid in the management of overweight and obesity in adult dogs. To be used as part of an overall weight management programme which also includes appropriate dietary changes. Introducing appropriate lifestyle changes (e.g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen Pharmaceutica N.V.", "european_commission_decision_date": "20/10/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/11/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "20/10/2008", "last_updated_date": "23/08/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/yarvitan" }, { "category": "Human", "name_of_medicine": "Ibandronic Acid Hexal", "ema_product_number": "EMEA/H/C/002366", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "ibandronic acid", "active_substance": "ibandronic acid", "therapeutic_area_mesh": "Hypercalcemia;Breast Neoplasms;Osteoporosis;Neoplasm Metastasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Ibandronic Acid Hexal is indicated for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour-induced hypercalcaemia with or without metastases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Hexal AG", "european_commission_decision_date": "18/02/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "21/07/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/08/2011", "last_updated_date": "22/08/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ibandronic-acid-hexal" }, { "category": "Human", "name_of_medicine": "Avaglim", "ema_product_number": "EMEA/H/C/000675", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A20/0029", "international_non_proprietary_name_common_name": "rosiglitazone;glimepiride", "active_substance": "rosiglitazone;glimepiride", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SmithKline Beecham Ltd", "european_commission_decision_date": "26/07/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/06/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "26/07/2011", "last_updated_date": "12/08/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/avaglim" }, { "category": "Human", "name_of_medicine": "Filgrastim ratiopharm", "ema_product_number": "EMEA/H/C/000824", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IB/0001/G", "international_non_proprietary_name_common_name": "filgrastim", "active_substance": "filgrastim", "therapeutic_area_mesh": "Hematopoietic Stem Cell Transplantation;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Filgrastim ratiopharm is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Filgrastim ratiopharm is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Filgrastim ratiopharm is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Filgrastim ratiopharm is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ratiopharm GmbH", "european_commission_decision_date": "20/04/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "20/04/2011", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "20/04/2011", "last_updated_date": "20/07/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-ratiopharm" }, { "category": "Human", "name_of_medicine": "Humenza", "ema_product_number": "EMEA/H/C/001202", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)", "active_substance": "split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs.", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with Official Guidance.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "Yes", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Pasteur S.A.", "european_commission_decision_date": "14/06/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/06/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "14/06/2011", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/06/2011", "last_updated_date": "30/06/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/humenza" }, { "category": "Human", "name_of_medicine": "Agenerase", "ema_product_number": "EMEA/H/C/000264", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0044", "international_non_proprietary_name_common_name": "amprenavir", "active_substance": "amprenavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years. Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5). The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).The benefit of Agenerase boosted with ritonavir has not been demonstrated in PI nave patients (see section 5.1)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Glaxo Group Ltd.", "european_commission_decision_date": "29/04/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/10/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "29/04/2010", "suspension_of_marketing_authorisation_date": "", "revision_number": "18", "first_published_date": "29/04/2011", "last_updated_date": "21/06/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/agenerase" }, { "category": "Human", "name_of_medicine": "Beprana", "ema_product_number": "EMEA/H/C/002159", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "naproxcinod", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "NicOx S. A.", "european_commission_decision_date": "27/05/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "19/04/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/05/2011", "last_updated_date": "27/05/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/beprana" }, { "category": "Human", "name_of_medicine": "Joicela", "ema_product_number": "EMEA/H/C/002104", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis", "european_commission_decision_date": "27/05/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "15/04/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/05/2011", "last_updated_date": "27/05/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/joicela" }, { "category": "Human", "name_of_medicine": "Enviage", "ema_product_number": "EMEA/H/C/000850", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0034", "international_non_proprietary_name_common_name": "aliskiren", "active_substance": "aliskiren", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09XA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd.", "european_commission_decision_date": "22/04/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/09/2010", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "22/04/2009", "last_updated_date": "19/05/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/enviage" }, { "category": "Human", "name_of_medicine": "Epostim", "ema_product_number": "EMEA/H/C/002265", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "epoetin alfa", "active_substance": "epoetin alfa", "therapeutic_area_mesh": "Anemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Reliance GeneMedix Plc", "european_commission_decision_date": "19/04/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "15/03/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/04/2011", "last_updated_date": "19/04/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/epostim" }, { "category": "Human", "name_of_medicine": "Onsenal", "ema_product_number": "EMEA/H/C/000466", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0028", "international_non_proprietary_name_common_name": "celecoxib", "active_substance": "celecoxib", "therapeutic_area_mesh": "Adenomatous Polyposis Coli", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX33", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4). The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "28/03/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/10/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/11/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "28/03/2011", "last_updated_date": "06/04/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/onsenal" }, { "category": "Human", "name_of_medicine": "Thelin", "ema_product_number": "EMEA/H/C/000679", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "T/0031", "international_non_proprietary_name_common_name": "sitaxentan sodium", "active_substance": "sitaxentan sodium", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C02KX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihypertensives", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Ltd.", "european_commission_decision_date": "06/01/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/08/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "06/01/2011", "suspension_of_marketing_authorisation_date": "", "revision_number": "13", "first_published_date": "06/01/2011", "last_updated_date": "02/03/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/thelin" }, { "category": "Human", "name_of_medicine": "Clopidogrel 1A Pharma", "ema_product_number": "EMEA/H/C/001054", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0002", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel", "therapeutic_area_mesh": "Peripheral Vascular Diseases", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Patients suffering from acute coronary syndrome: - Non ST segment elevation acute coronary syndrome (unstable angina or non Q wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. For further information please refer to section 5.1.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Acino Pharma GmbH", "european_commission_decision_date": "01/02/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/07/2009", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/02/2011", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "01/02/2011", "last_updated_date": "28/02/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-1a-pharma" }, { "category": "Human", "name_of_medicine": "Topotecan SUN", "ema_product_number": "EMEA/H/C/002091", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "topotecan", "active_substance": "topotecan", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries Europe B.V.", "european_commission_decision_date": "23/02/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "03/01/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/02/2011", "last_updated_date": "23/02/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/topotecan-sun" }, { "category": "Human", "name_of_medicine": "Movectro", "ema_product_number": "EMEA/H/C/001197", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "cladribine", "active_substance": "cladribine", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01BB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Serono Europe Limited", "european_commission_decision_date": "27/09/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "08/02/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/02/2011", "last_updated_date": "23/02/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/movectro" }, { "category": "Human", "name_of_medicine": "Cerepro", "ema_product_number": "EMEA/H/C/001103", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ark Therapeutics", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "08/03/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2010", "last_updated_date": "01/02/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cerepro" }, { "category": "Human", "name_of_medicine": "Tekinex", "ema_product_number": "EMEA/H/C/001244", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "omacetaxine mepesuccinate", "therapeutic_area_mesh": "Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XX40", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ChemGenex Europe SAS", "european_commission_decision_date": "31/01/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "11/01/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/01/2011", "last_updated_date": "31/01/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tekinex" }, { "category": "Human", "name_of_medicine": "Ozespa", "ema_product_number": "EMEA/H/C/002019", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "briakinumab", "therapeutic_area_mesh": "Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AC09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Abbott Laboratories Ltd.", "european_commission_decision_date": "31/01/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "14/01/2011", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/01/2011", "last_updated_date": "31/01/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ozespa" }, { "category": "Human", "name_of_medicine": "Ionsys", "ema_product_number": "EMEA/H/C/000612", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A20-0013", "international_non_proprietary_name_common_name": "fentanyl", "active_substance": "fentanyl hydrochloride", "therapeutic_area_mesh": "Pain, Postoperative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02AB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Management of acute moderate to severe post-operative pain for use in a hospital setting only", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "24/01/2011", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/01/2006", "refusal_of_marketing_authorisation_date": "25/07/2008", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "24/01/2011", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "24/01/2011", "last_updated_date": "28/01/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ionsys-0" }, { "category": "Human", "name_of_medicine": "ImmunoGam", "ema_product_number": "EMEA/H/C/001055", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "human hepatitis B immunoglobulin", "active_substance": "human hepatitis B immunoglobulin", "therapeutic_area_mesh": "Immunization, Passive;Hepatitis B", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J06BB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Specific immunoglobulins", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Immunoprophylaxis of Hepatitis B - In case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown). - In haemodialysed patients, until vaccination has become effective. - In the newborn of a hepatitis B virus carrier-mother. - In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B. Consideration should also be given to other official guidance on the appropriate use of human hepatitis B immunoglobulin for intramuscular use.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Cangene Europe Limited", "european_commission_decision_date": "06/09/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/03/2010", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "06/09/2010", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "06/09/2010", "last_updated_date": "26/01/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/immunogam" }, { "category": "Human", "name_of_medicine": "Zenhale", "ema_product_number": "EMEA/H/C/001217", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "Formoterol (fumarate);mometasone furoate", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R03AK07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for obstructive airway diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Schering-Plough Europe", "european_commission_decision_date": "25/11/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "05/11/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/11/2010", "last_updated_date": "20/01/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zenhale" }, { "category": "Human", "name_of_medicine": "Emerflu", "ema_product_number": "EMEA/H/C/000859", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BB", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Prophylaxis of influenza in an officially declared pandemic situation in adults. Pandemic influenza vaccine should be used in accordance with official guidance (see sections 4.2, 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Pasteur S.A.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "01/12/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/12/2010", "last_updated_date": "20/12/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/emerflu" }, { "category": "Human", "name_of_medicine": "Rasival", "ema_product_number": "EMEA/H/C/001191", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd", "european_commission_decision_date": "17/09/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "15/09/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/09/2010", "last_updated_date": "22/11/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rasival" }, { "category": "Human", "name_of_medicine": "NeoSpect", "ema_product_number": "EMEA/H/C/000263", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0015", "international_non_proprietary_name_common_name": "depreotide", "active_substance": "depreotide trifluoroacetate", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09IA05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This medicinal product is for diagnostic use only.For scintigraphic imaging of suspected malignant tumours in the lung after initial detection, incombination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CIS bio international", "european_commission_decision_date": "28/10/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/11/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/10/2010", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "28/10/2010", "last_updated_date": "18/11/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neospect" }, { "category": "Veterinary", "name_of_medicine": "Gallimune Flu H5N9 (i)", "ema_product_number": "EMEA/V/C/002229", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "european_commission_decision_date": "16/11/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "05/10/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/11/2010", "last_updated_date": "16/11/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/gallimune-flu-h5n9-i" }, { "category": "Human", "name_of_medicine": "Zeftera (previously Zevtera)", "ema_product_number": "EMEA/H/C/000883", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ceftobiprole", "active_substance": "ceftobiprole medocaril", "therapeutic_area_mesh": "Skin Diseases, Infectious;Soft Tissue Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01DI01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "16/09/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/06/2010", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "16/09/2010", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/09/2010", "last_updated_date": "22/09/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zeftera" }, { "category": "Veterinary", "name_of_medicine": "Medicinal Oxygen Air Liquide Sante", "ema_product_number": "EMEA/V/C/000111", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "oxygen", "active_substance": "oxygen", "therapeutic_area_mesh": "", "species_veterinary": "Horses;Dogs;Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QV03AN01", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "All other therapeutic products", "therapeutic_indication": "For oxygen supplementation and as a carrier gas during inhalation anaesthesia.For oxygen supplementation during recovery.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Air Liquide Santé International", "european_commission_decision_date": "20/12/2006", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/12/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/12/2006", "last_updated_date": "21/09/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/medicinal-oxygen-air-liquide-sante" }, { "category": "Veterinary", "name_of_medicine": "Nobilis Influenza H5N6", "ema_product_number": "EMEA/V/C/000125", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "S/0001", "international_non_proprietary_name_common_name": "adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5", "active_substance": "inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84)", "therapeutic_area_mesh": "", "species_veterinary": "Chicken", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI01AA23", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves", "therapeutic_indication": "For active immunisation of chickens against avian influenza type A, subtype H5.Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination.Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "05/07/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/01/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "05/07/2010", "last_updated_date": "26/07/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-influenza-h5n6" }, { "category": "Veterinary", "name_of_medicine": "Nobilis Influenza H7N1", "ema_product_number": "EMEA/V/C/000123", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "S/0003", "international_non_proprietary_name_common_name": "adjuvanted inactivated vaccine against avian influenza virus type A, subtype H7", "active_substance": "inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99)", "therapeutic_area_mesh": "", "species_veterinary": "Chicken;Ducks", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI01AA23", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for aves", "therapeutic_indication": "For active immunisation of chickens and ducks against avian influenza type A, subtype H7N1. Efficacy has been evaluated on the basis of preliminary results in chickens and ringed teals. In chickens, reduction of clinical signs, mortality, excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination. In ducks, reduction of excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination. Although it has not been investigated with this particular AI vaccine strain, studies performed with other strains show that protective levels of serum antibody titres would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. The duration of immunity in ducks is unknown.", "accelerated_assessment": "Yes", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "Yes", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "07/07/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "14/05/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "07/07/2010", "last_updated_date": "26/07/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-influenza-h7n1" }, { "category": "Veterinary", "name_of_medicine": "Pruban", "ema_product_number": "EMEA/V/C/000048", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0004", "international_non_proprietary_name_common_name": "resocortol butyrate", "active_substance": "resocortol butyrate", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QD07AC90", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Corticosteroids, dermatological preparations", "therapeutic_indication": "Treatment of acute localised moist dermatitis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Intervet International BV", "european_commission_decision_date": "14/06/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/11/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "14/06/2010", "last_updated_date": "26/07/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/pruban" }, { "category": "Human", "name_of_medicine": "Brilence", "ema_product_number": "EMEA/H/C/001237", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "bazedoxifene", "active_substance": "bazedoxifene", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G03XC02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Sex hormones and modulators of the genital system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Wyeth Europa Ltd", "european_commission_decision_date": "11/06/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "21/05/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/05/2010", "last_updated_date": "29/06/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/brilence" }, { "category": "Human", "name_of_medicine": "Sliwens", "ema_product_number": "EMEA/H/C/001102", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Sleep Initiation and Maintenance Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Aventis", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "18/12/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/12/2009", "last_updated_date": "01/06/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sliwens" }, { "category": "Human", "name_of_medicine": "Tyvaso", "ema_product_number": "EMEA/H/C/001115", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "treprostinil sodium", "therapeutic_area_mesh": "Hypertension, Pulmonary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "United Therapeutics Europe Ltd", "european_commission_decision_date": "26/04/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/02/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/03/2010", "last_updated_date": "17/05/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tyvaso" }, { "category": "Human", "name_of_medicine": "Repaglinide Sun", "ema_product_number": "EMEA/H/C/001145", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "repaglinide", "active_substance": "repaglinide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sun Pharmaceutical Industries B.V.", "european_commission_decision_date": "26/04/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "25/03/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/03/2010", "last_updated_date": "15/05/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/repaglinide-sun" }, { "category": "Human", "name_of_medicine": "Joulferon", "ema_product_number": "EMEA/H/C/002166", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "26/04/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "16/04/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/04/2010", "last_updated_date": "29/04/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/joulferon" }, { "category": "Human", "name_of_medicine": "Impulsor", "ema_product_number": "EMEA/H/C/001122", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "milnacipran", "active_substance": "milnacipran", "therapeutic_area_mesh": "Fibromyalgia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pierre Fabre Medicament", "european_commission_decision_date": "26/04/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "08/04/2010", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/04/2010", "last_updated_date": "26/04/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/impulsor" }, { "category": "Human", "name_of_medicine": "Milnacipran Pierre Fabre Medicament", "ema_product_number": "EMEA/H/C/001034", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "milnacipran", "active_substance": "milnacipran", "therapeutic_area_mesh": "Fibromyalgia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pierre Fabre Medicament", "european_commission_decision_date": "26/04/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "08/04/2010", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/04/2010", "last_updated_date": "26/04/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/milnacipran-pierre-fabre-medicament" }, { "category": "Human", "name_of_medicine": "Ibuprofen/Diphenhydramine Hydrochloride Wyeth", "ema_product_number": "EMEA/H/C/001108", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "Ibuprofen", "therapeutic_area_mesh": "Pain", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Wyeth Consumer Healthcare", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "07/01/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/01/2010", "last_updated_date": "20/04/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ibuprofen-diphenhydramine-hydrochloride-wyeth" }, { "category": "Human", "name_of_medicine": "Docetaxel Mylan", "ema_product_number": "EMEA/H/C/001193", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "docetaxel", "active_substance": "docetaxel", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung;Breast Neoplasms;Head and Neck Neoplasms;Stomach Neoplasms;Adenocarcinoma;Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "Yes", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Mylan S.A.S.", "european_commission_decision_date": "26/04/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "08/03/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/03/2010", "last_updated_date": "26/03/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/docetaxel-mylan" }, { "category": "Veterinary", "name_of_medicine": "Pulsaflox", "ema_product_number": "EMEA/V/C/000060", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "difloxacin", "active_substance": "difloxacin", "therapeutic_area_mesh": "", "species_veterinary": "Turkeys;Chicken", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QJ01MA", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "In chickens and turkeys Pulsaflox oral solution is indicated for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.In turkeys Pulsaflox oral solution is also indicated for the treatment of infections caused by Pasteurella multocida.Pulsaflox oral solution should only be used based on susceptibility testing.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Virbac S.A.", "european_commission_decision_date": "25/03/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/11/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/03/2010", "last_updated_date": "25/03/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/pulsaflox" }, { "category": "Human", "name_of_medicine": "Ratioepo", "ema_product_number": "EMEA/H/C/001035", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "epoetin theta", "active_substance": "epoetin theta", "therapeutic_area_mesh": "Anemia;Kidney Failure;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic anaemia associated with chronic renal failure in adult patients and treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ratiopharm GmbH", "european_commission_decision_date": "26/04/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "25/02/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/03/2010", "last_updated_date": "22/03/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ratioepo" }, { "category": "Human", "name_of_medicine": "Paxene", "ema_product_number": "EMEA/H/C/000216", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "R/0047", "international_non_proprietary_name_common_name": "paclitaxel", "active_substance": "paclitaxel", "therapeutic_area_mesh": "Sarcoma, Kaposi;Carcinoma, Non-Small-Cell Lung;Ovarian Neoplasms;Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CD01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Paxene is indicated for the treatment of patients with: advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy; metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy; advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment; metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment; non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin. Limited efficacy data supports this indication (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Norton Healthcare Ltd.", "european_commission_decision_date": "14/07/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/07/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/03/2010", "suspension_of_marketing_authorisation_date": "", "revision_number": "14", "first_published_date": "14/07/2009", "last_updated_date": "22/03/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/paxene" }, { "category": "Human", "name_of_medicine": "Bextra", "ema_product_number": "EMEA/H/C/000431", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "valdecoxib", "active_substance": "valdecoxib", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Osteoarthritis;Dysmenorrhea", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M01AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiinflammatory and antirheumatic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risk (see sections 4.3, 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharmacia - Pfizer EEIG", "european_commission_decision_date": "03/02/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/03/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/03/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "03/02/2010", "last_updated_date": "03/02/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bextra" }, { "category": "Human", "name_of_medicine": "Clopidogrel BMS", "ema_product_number": "EMEA/H/C/000974", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0012", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel (as hydrogen sulfate)", "therapeutic_area_mesh": "Stroke;Peripheral Vascular Diseases;Myocardial Infarction;Acute Coronary Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: - Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. - Patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "26/10/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/07/2008", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "12/11/2009", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "26/10/2009", "last_updated_date": "26/01/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-bms" }, { "category": "Human", "name_of_medicine": "Comfyde", "ema_product_number": "EMEA/H/C/001221", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "carisbamate", "therapeutic_area_mesh": "Epilepsy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Janssen-Cilag International NV", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "15/01/2010", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/01/2010", "last_updated_date": "20/01/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/comfyde" }, { "category": "Human", "name_of_medicine": "Turvel", "ema_product_number": "EMEA/H/C/000158", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "trovafloxacin", "active_substance": "trovafloxacin", "therapeutic_area_mesh": "Bacterial Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01MA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trovafloxacin is a synthetic broad spectrum quinolone antibacterial agent indicated for the treatment of the following infections in adults: Pneumonia: Community Acquired Pneumonia and Nosocomial Pneumonia (mild, moderate, and severe). Note: Efficacy in patients with very severe nosocomial pneumonia and in particular infections due to less susceptible pathogens e.g. P. aeruginosa, has not been established. See also section 4.2. Acute Exacerbations of Chronic Bronchitis Acute Sinusitis Complicated Intra-abdominal Infections and Acute Pelvic Infections Salpingitis Uncomplicated Gonococcal Urethritis and Cervicitis Chlamydial Cervicitis Complicated Skin and Soft Tissue Infections Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "11/01/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/07/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "20/03/2001", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/01/2010", "last_updated_date": "11/01/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/turvel" }, { "category": "Human", "name_of_medicine": "Turvel IV", "ema_product_number": "EMEA/H/C/000159", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "trovafloxacin", "active_substance": "alatrofloxacin mesilate", "therapeutic_area_mesh": "Bacterial Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01MA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trovafloxacin is a synthetic broad spectrum quinolone antibacterial agent indicated for the treatment of the following infections in adults: Pneumonia: Community Acquired Pneumonia and Nosocomial Pneumonia (mild, moderate, and severe). Note: Efficacy in patients with very severe nosocomial pneumonia and in particular infections due to less susceptible pathogens e.g. P. aeruginosa, has not been established. See also section 4.2. Acute Exacerbations of Chronic Bronchitis Acute Sinusitis Complicated Intra-abdominal Infections and Acute Pelvic Infections Salpingitis Uncomplicated Gonococcal Urethritis and Cervicitis Chlamydial Cervicitis Complicated Skin and Soft Tissue Infections Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "11/01/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/07/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "20/03/2001", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/01/2010", "last_updated_date": "11/01/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/turvel-iv" }, { "category": "Human", "name_of_medicine": "Sovrima", "ema_product_number": "EMEA/H/C/000908", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "idebenone", "active_substance": "idebenone", "therapeutic_area_mesh": "Friedreich Ataxia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N06BX13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psychoanaleptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of Friedreichâ??s Ataxia", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Centocor B.V.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "27/04/2009", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sovrima" }, { "category": "Human", "name_of_medicine": "Trovan IV", "ema_product_number": "EMEA/H/C/000161", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "trovafloxacin", "active_substance": "alatrofloxacin mesilate", "therapeutic_area_mesh": "Bacterial Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01MA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trovafloxacin is a synthetic broad spectrum quinolone antibacterial agent indicated for the treatment of the following infections in adults: Pneumonia: Community Acquired Pneumonia and Nosocomial Pneumonia (mild, moderate, and severe). Note: Efficacy in patients with very severe nosocomial pneumonia and in particular infections due to less susceptible pathogens e.g. P. aeruginosa, has not been established. See also section 4.2. Acute Exacerbations of Chronic Bronchitis Acute Sinusitis Complicated Intra-abdominal Infections and Acute Pelvic Infections Salpingitis Uncomplicated Gonococcal Urethritis and Cervicitis Chlamydial Cervicitis Complicated Skin and Soft Tissue Infections Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/07/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "20/03/2001", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trovan-iv" }, { "category": "Human", "name_of_medicine": "Allex", "ema_product_number": "EMEA/H/C/000312", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "desloratadine", "active_substance": "desloratadine", "therapeutic_area_mesh": "Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R06AX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihistamines for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Aerius is indicated for the relief of symptoms associated with: allergic rhinitis (see section 5.1) urticaria (see section 5.1)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Schering-Plough Europe", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/01/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "10/03/2004", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/allex" }, { "category": "Human", "name_of_medicine": "Evotopin", "ema_product_number": "EMEA/H/C/000124", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "topotecan", "active_substance": "topotecan", "therapeutic_area_mesh": "Ovarian Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Beecham Group plc", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/04/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/evotopin" }, { "category": "Human", "name_of_medicine": "Trovan", "ema_product_number": "EMEA/H/C/000160", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "trovafloxacin", "active_substance": "trovafloxacin", "therapeutic_area_mesh": "Bacterial Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01MA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Trovafloxacin is a synthetic broad spectrum quinolone antibacterial agent indicated for the treatment of the following infections in adults:Pneumonia: Community Acquired Pneumonia and Nosocomial Pneumonia (mild, moderate, and severe). Note: Efficacy in patients with very severe nosocomial pneumonia and in particular infections due to less susceptible pathogens e.g. P. aeruginosa, has not been established. See also section 4.2. Acute Exacerbations of Chronic Bronchitis Acute Sinusitis Complicated Intra-abdominal Infections and Acute Pelvic Infections Salpingitis Uncomplicated Gonococcal Urethritis and Cervicitis Chlamydial Cervicitis Complicated Skin and Soft Tissue Infections Consideration should be given to official guidance on the appropriate use of antibacterial agents.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/07/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "20/03/2001", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trovan" }, { "category": "Human", "name_of_medicine": "Indimacis 125", "ema_product_number": "EMEA/H/C/000065", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "igovomab", "active_substance": "igovomab", "therapeutic_area_mesh": "Radionuclide Imaging;Ovarian Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09IB03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Positive diagnosis of relapsing ovarian adenocarcinoma when serum CA 125 is increased without positive results of ultrasound or computerised tomography scan.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CIS bio international", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/10/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/indimacis-125" }, { "category": "Human", "name_of_medicine": "Rotashield", "ema_product_number": "EMEA/H/C/000192", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rotavirus vaccine", "active_substance": "rotavirus serotype 1 reassortant, rotavirus serotype 2 reassortant, rotavirus serotype 3 rhesus, rotavirus serotype 4 reassortant", "therapeutic_area_mesh": "Immunization;Rotavirus Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BH", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "RotaShield is indicated for active immunisation of infants aged 6 weeks to 30 weeks for prevention of severe clinical manifestations of gastro-enteritis caused by rotavirus serotypes 1, 2, 3 and 4 of group A.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Wyeth Lederle Vaccines S.A.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/05/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/01/2001", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rotashield" }, { "category": "Human", "name_of_medicine": "Destara", "ema_product_number": "EMEA/H/C/000103", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ibandronic acid", "active_substance": "ibandronic acid", "therapeutic_area_mesh": "Hypercalcemia;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M05BA06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for treatment of bone diseases", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of tumour-induced hypercalcaemia with or without metastases.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration Ltd.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/06/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/destara" }, { "category": "Human", "name_of_medicine": "Zelnorm", "ema_product_number": "EMEA/H/C/000621", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tegaserod", "active_substance": "tegaserod", "therapeutic_area_mesh": "Irritable Bowel Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A03AE02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs for functional gastrointestinal disorders", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zelnorm is indicated for the repeated symptomatic short-term treatment of women with Irritable Bowel Syndrome (IBS) whose predominant bowel habit is constipation, associated with abdominal pain/discomfort or bloating (see section 4.2).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "23/03/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "19/05/2006", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zelnorm" }, { "category": "Human", "name_of_medicine": "Tikosyn", "ema_product_number": "EMEA/H/C/000238", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dofetilide", "active_substance": "dofetilide", "therapeutic_area_mesh": "Atrial Fibrillation;Atrial Flutter", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C01BD04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Cardiac therapy", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tikosyn is a Class III antiarrhythmic agent that is indicated for the following: Conversion of persistent atrial fibrillation or atrial flutter to normal sinus rhythm in patients in whom cardioversion by electrical means is not appropriate and in whom the duration of the arrhythmic episode is less than 6 months (see section 5.1). Maintenance of sinus rhythm (after conversion) in patients with persistent atrial fibrillation or atrial flutter. Because TIKOSYN can cause ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic and in whom other antiarrhythmic therapy is not appropriate. Dofetilide has not been shown to be effective in patients with paroxysmal atrial arrhythmias (including paroxysmal atrial fibrillation).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/11/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "02/03/2004", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tikosyn" }, { "category": "Human", "name_of_medicine": "Tecnemab K1", "ema_product_number": "EMEA/H/C/000068", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "anti-melanoma mab fragments", "active_substance": "anti-melanoma mab fragments", "therapeutic_area_mesh": "Radioimmunodetection", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09IA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "As an adjunct to other diagnostic procedures for visualization by radioimmunoscintigraphy (RIS) of regional lymph node and distant metastases in the staging and follow-up of patients with stage I-III melanoma. Aid in differential diagnosis of suspected ocular melanoma.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amersham Sorin.S.r.l.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/09/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tecnemab-k1" }, { "category": "Human", "name_of_medicine": "Rhucin", "ema_product_number": "EMEA/H/C/000769", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "recombinant human C1 inhibitor", "active_substance": "recombinant human C1-inhibitor", "therapeutic_area_mesh": "Angioedema", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B06C", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other hematological agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Replacement treatment in acute attacks of angioedema in patients with congenital C1INH activity deficiency.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharming Group N.V.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "13/12/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "22/05/2008", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rhucin" }, { "category": "Human", "name_of_medicine": "Genasense", "ema_product_number": "EMEA/H/C/000711", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "oblimersen", "active_substance": "oblimersen", "therapeutic_area_mesh": "Melanoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Genta Development Ltd. c/o Ross Craig", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/07/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "15/10/2007", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/genasense" }, { "category": "Human", "name_of_medicine": "Oncophage", "ema_product_number": "EMEA/H/C/001072", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Antigenics Therapeutics Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "23/11/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/12/2009", "last_updated_date": "21/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/oncophage" }, { "category": "Human", "name_of_medicine": "Advexin", "ema_product_number": "EMEA/H/C/000919", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Li-Fraumeni Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gendux Molecular Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/12/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/12/2009", "last_updated_date": "19/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/advexin" }, { "category": "Human", "name_of_medicine": "Recothrom", "ema_product_number": "EMEA/H/C/001063", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "thrombin alfa", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer Schering Pharma AG", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "11/12/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/12/2009", "last_updated_date": "14/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/recothrom" }, { "category": "Human", "name_of_medicine": "Ethyl Eicosapent soft gelatin capsules", "ema_product_number": "EMEA/H/C/001148", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Amarin Neuroscience Ltd", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "01/12/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/12/2009", "last_updated_date": "08/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ethyl-eicosapent-soft-gelatin-capsules" }, { "category": "Human", "name_of_medicine": "Nenad", "ema_product_number": "EMEA/H/C/001020", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "lisuride", "therapeutic_area_mesh": "Restless Legs Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Axxonis Pharma AG", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "30/11/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "03/12/2009", "last_updated_date": "03/12/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nenad" }, { "category": "Human", "name_of_medicine": "Irbesartan BMS", "ema_product_number": "EMEA/H/C/000786", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0018", "international_non_proprietary_name_common_name": "irbesartan", "active_substance": "irbesartan", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09CA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "07/04/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "11/11/2009", "suspension_of_marketing_authorisation_date": "", "revision_number": "7", "first_published_date": "07/04/2009", "last_updated_date": "26/11/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/irbesartan-bms" }, { "category": "Human", "name_of_medicine": "Irbesartan Hydrochlorothiazide BMS", "ema_product_number": "EMEA/H/C/000784", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0030", "international_non_proprietary_name_common_name": "irbesartan;hydrochlorothiazide", "active_substance": "irbesartan;hydrochlorothiazide", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09DA04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension.This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "09/10/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/01/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "11/11/2009", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "09/10/2009", "last_updated_date": "24/11/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/irbesartan-hydrochlorothiazide-bms" }, { "category": "Human", "name_of_medicine": "Gemesis", "ema_product_number": "EMEA/H/C/000997", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "becaplermin", "active_substance": "becaplermin", "therapeutic_area_mesh": "Guided Tissue Regeneration, Periodontal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioMimetic Therapeutics Ltd", "european_commission_decision_date": "20/11/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/11/2009", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "29/01/2010", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/11/2009", "last_updated_date": "20/11/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gemesis" }, { "category": "Human", "name_of_medicine": "Zactima", "ema_product_number": "EMEA/H/C/001194", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "vandetanib", "active_substance": "vandetanib", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "27/10/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/10/2009", "last_updated_date": "30/10/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zactima" }, { "category": "Human", "name_of_medicine": "Mersarex", "ema_product_number": "EMEA/H/C/001057", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Skin Diseases, Bacterial;Soft Tissue Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Arpida A/S", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "21/10/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/10/2009", "last_updated_date": "23/10/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mersarex" }, { "category": "Human", "name_of_medicine": "Zunrisa", "ema_product_number": "EMEA/H/C/001040", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "casopitant", "therapeutic_area_mesh": "Vomiting;Postoperative Nausea and Vomiting;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Glaxo Group Ltd", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "25/09/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/10/2009", "last_updated_date": "13/10/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zunrisa" }, { "category": "Human", "name_of_medicine": "Tekturna", "ema_product_number": "EMEA/H/C/000852", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0034", "international_non_proprietary_name_common_name": "aliskiren", "active_substance": "aliskiren", "therapeutic_area_mesh": "Hypertension", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "C09XA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Agents acting on the renin-angiotensin system", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of essential hypertension", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd.", "european_commission_decision_date": "22/04/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2007", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "02/09/2009", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "22/04/2009", "last_updated_date": "25/09/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tekturna" }, { "category": "Human", "name_of_medicine": "Opaxio", "ema_product_number": "EMEA/H/C/000994", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Carcinoma, Non-Small-Cell Lung", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CTI Life Sciences Ltd", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "21/09/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/09/2009", "last_updated_date": "23/09/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opaxio" }, { "category": "Human", "name_of_medicine": "Ramvocid", "ema_product_number": "EMEA/H/C/001025", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "oritavancin", "active_substance": "", "therapeutic_area_mesh": "Gram-Positive Bacterial Infections;Skin Diseases, Bacterial;Soft Tissue Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Targanta Netherlands B.V.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/08/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/08/2009", "last_updated_date": "25/08/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ramvocid" }, { "category": "Human", "name_of_medicine": "Trazec", "ema_product_number": "EMEA/H/C/000383", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0017", "international_non_proprietary_name_common_name": "nateglinide", "active_substance": "nateglinide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BX03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Europharm Ltd.", "european_commission_decision_date": "23/07/2007", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "03/04/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "20/11/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "23/07/2007", "last_updated_date": "24/08/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trazec" }, { "category": "Human", "name_of_medicine": "Posaconazole SP", "ema_product_number": "EMEA/H/C/000611", "medicine_status": "Lapsed", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0011", "international_non_proprietary_name_common_name": "posaconazole", "active_substance": "posaconazole", "therapeutic_area_mesh": "Candidiasis;Mycoses;Coccidioidomycosis;Aspergillosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02AC04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Posaconazole SP is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Posaconazole SP is also indicated for prophylaxis of invasive fungal infections in the following patients:- Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who areat high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Schering-Plough Europe", "european_commission_decision_date": "04/12/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/10/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "20/11/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "04/12/2008", "last_updated_date": "04/08/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/posaconazole-sp" }, { "category": "Human", "name_of_medicine": "Raptiva", "ema_product_number": "EMEA/H/C/000542", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0026", "international_non_proprietary_name_common_name": "efalizumab", "active_substance": "efalizumab", "therapeutic_area_mesh": "Psoriasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA21", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (see section 5.1 - Clinical Efficacy).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Serono Europe Limited", "european_commission_decision_date": "25/11/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/09/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/06/2009", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "25/11/2008", "last_updated_date": "04/08/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/raptiva" }, { "category": "Human", "name_of_medicine": "Bosatria", "ema_product_number": "EMEA/H/C/001069", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "mepolizumab", "active_substance": "Mepolizumab", "therapeutic_area_mesh": "Hypereosinophilic Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Glaxo Group Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "28/07/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/07/2009", "last_updated_date": "29/07/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/bosatria" }, { "category": "Human", "name_of_medicine": "Procomvax", "ema_product_number": "EMEA/H/C/000231", "medicine_status": "Expired", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0028", "international_non_proprietary_name_common_name": "haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine", "active_substance": "polyribosylribitol phosphate from Haemophilus influenzae type b as PRP-OMPC;outer membrane protein complex of Neisseria meningitidis (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B);adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae)", "therapeutic_area_mesh": "Hepatitis B;Meningitis, Haemophilus;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07CA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "PROCOMVAX is indicated for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Pasteur MSD, SNC", "european_commission_decision_date": "11/12/2007", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/05/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "14/05/2009", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "11/12/2007", "last_updated_date": "29/07/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/procomvax" }, { "category": "Human", "name_of_medicine": "Contusugene Ladenovec Gendux", "ema_product_number": "EMEA/H/C/001041", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Head and Neck Neoplasms;Carcinoma, Squamous Cell", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Gendux Molecular Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "12/06/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/07/2009", "last_updated_date": "23/07/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/contusugene-ladenovec-gendux" }, { "category": "Human", "name_of_medicine": "Factive", "ema_product_number": "EMEA/H/C/000995", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Bronchitis, Chronic;Pneumonia, Bacterial", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Menarini International Operations Luxembourg S.A.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/06/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/06/2009", "last_updated_date": "23/06/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/factive" }, { "category": "Human", "name_of_medicine": "Biferonex", "ema_product_number": "EMEA/H/C/000901", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "interferon beta-1a", "active_substance": "interferon beta-1a", "therapeutic_area_mesh": "Multiple Sclerosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioPartners GmbH", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "28/05/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/05/2009", "last_updated_date": "29/05/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/biferonex" }, { "category": "Human", "name_of_medicine": "Lunivia", "ema_product_number": "EMEA/H/C/000895", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "eszopiclone", "therapeutic_area_mesh": "Sleep Initiation and Maintenance Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sepracor Ltd.", "european_commission_decision_date": "15/05/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/05/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/05/2009", "last_updated_date": "15/05/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lunivia" }, { "category": "Human", "name_of_medicine": "Parareg", "ema_product_number": "EMEA/H/C/000575", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0015", "international_non_proprietary_name_common_name": "cinacalcet", "active_substance": "cinacalcet", "therapeutic_area_mesh": "Hypercalcemia;Parathyroid Neoplasms;Hyperparathyroidism", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05BX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1). Reduction of hypercalcaemia in patients with: parathyroid carcinoma. primary HPT for whom parathyroidectomy would be indicated on the basis of serum calciumlevels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dompé Biotec S.p.A.", "european_commission_decision_date": "29/10/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/10/2004", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "05/12/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "29/10/2008", "last_updated_date": "14/05/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/parareg" }, { "category": "Human", "name_of_medicine": "Clopidogrel Teva Pharma", "ema_product_number": "EMEA/H/C/001052", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "clopidogrel", "active_substance": "clopidogrel", "therapeutic_area_mesh": "Ischemic Attack, Transient;Peripheral Vascular Diseases;Myocardial Infarction;Acute Coronary Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Teva Pharma B.V.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "22/04/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-teva-pharma" }, { "category": "Human", "name_of_medicine": "Dynepo", "ema_product_number": "EMEA/H/C/000372", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0020", "international_non_proprietary_name_common_name": "epoetin delta", "active_substance": "epoetin delta", "therapeutic_area_mesh": "Kidney Failure, Chronic;Anemia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Dynepo is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult patients. It may be used in patients on dialysis and in patients not on dialysis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Shire Pharmaceutical Contracts Limited", "european_commission_decision_date": "29/02/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/03/2002", "refusal_of_marketing_authorisation_date": "12/03/2008", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "17/03/2009", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "29/02/2008", "last_updated_date": "23/04/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/dynepo" }, { "category": "Veterinary", "name_of_medicine": "Kexxtone", "ema_product_number": "EMEA/V/C/000131", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Elanco animal health", "european_commission_decision_date": "26/04/2010", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "08/09/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/04/2009", "last_updated_date": "22/04/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/kexxtone-0" }, { "category": "Human", "name_of_medicine": "Velosulin", "ema_product_number": "EMEA/H/C/000423", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0007", "international_non_proprietary_name_common_name": "insulin human (rDNA)", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "16/03/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/10/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "30/01/2009", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "16/03/2008", "last_updated_date": "17/04/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/velosulin" }, { "category": "Human", "name_of_medicine": "Ixempra", "ema_product_number": "EMEA/H/C/000930", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Breast Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol-Myers Squibb Pharma EEIG", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "18/03/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/03/2009", "last_updated_date": "19/03/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ixempra" }, { "category": "Human", "name_of_medicine": "Cylatron", "ema_product_number": "EMEA/H/C/000921", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "peginterferon alfa-2b", "active_substance": "peginterferon alfa-2b", "therapeutic_area_mesh": "Melanoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SP Europe", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "11/03/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/03/2009", "last_updated_date": "16/03/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cylatron" }, { "category": "Human", "name_of_medicine": "Vorinostat MSD", "ema_product_number": "EMEA/H/C/000947", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "vorinostat", "therapeutic_area_mesh": "Lymphoma, T-Cell, Cutaneous", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merck Sharp Dohme Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/02/2009", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/02/2009", "last_updated_date": "17/02/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vorinostat-msd" }, { "category": "Human", "name_of_medicine": "Zenapax", "ema_product_number": "EMEA/H/C/000198", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0026", "international_non_proprietary_name_common_name": "daclizumab", "active_substance": "daclizumab", "therapeutic_area_mesh": "Graft Rejection;Kidney Transplantation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration Ltd.", "european_commission_decision_date": "23/01/2007", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "26/02/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "01/01/2009", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "23/01/2007", "last_updated_date": "13/02/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zenapax" }, { "category": "Human", "name_of_medicine": "Zimulti", "ema_product_number": "EMEA/H/C/000691", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0011", "international_non_proprietary_name_common_name": "rimonabant", "active_substance": "rimonabant", "therapeutic_area_mesh": "Obesity", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A08AX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiobesity preparations, excl. diet products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "As an adjunct to diet and exercise for the treatment of obese patients (BMI 30 kg/m2), or overweight patients (BMI 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "sanofi-aventis", "european_commission_decision_date": "17/07/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/06/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "16/01/2009", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "17/07/2008", "last_updated_date": "30/01/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zimulti" }, { "category": "Human", "name_of_medicine": "Acomplia", "ema_product_number": "EMEA/H/C/000666", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0011", "international_non_proprietary_name_common_name": "rimonabant", "active_substance": "rimonabant", "therapeutic_area_mesh": "Obesity", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A08AX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiobesity preparations, excl. diet products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "As an adjunct to diet and exercise for the treatment of obese patients (BMI 30 kg/m2), or overweight patients (BMI 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "sanofi-aventis", "european_commission_decision_date": "17/07/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "19/06/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "16/01/2009", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "17/07/2008", "last_updated_date": "30/01/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/acomplia" }, { "category": "Human", "name_of_medicine": "Nespo", "ema_product_number": "EMEA/H/C/000333", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0047", "international_non_proprietary_name_common_name": "darbepoetin alfa", "active_substance": "darbepoetin alfa", "therapeutic_area_mesh": "Kidney Failure, Chronic;Anemia;Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B03XA02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antianemic preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dompé Biotec S.p.A.", "european_commission_decision_date": "28/10/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/06/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "05/12/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "19", "first_published_date": "28/10/2008", "last_updated_date": "28/01/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nespo" }, { "category": "Human", "name_of_medicine": "Neupopeg", "ema_product_number": "EMEA/H/C/000422", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0037", "international_non_proprietary_name_common_name": "pegfilgrastim", "active_substance": "pegfilgrastim", "therapeutic_area_mesh": "Cancer", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AA13", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dompé Biotec S.p.A.", "european_commission_decision_date": "18/04/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/08/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "05/12/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "9", "first_published_date": "18/04/2008", "last_updated_date": "25/01/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/neupopeg" }, { "category": "Human", "name_of_medicine": "Theraloc", "ema_product_number": "EMEA/H/C/000931", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "nimotuzumab", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Oncoscience AG", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "01/12/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "04/12/2008", "last_updated_date": "04/12/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/theraloc" }, { "category": "Human", "name_of_medicine": "Forcaltonin", "ema_product_number": "EMEA/H/C/000197", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "IA/0015", "international_non_proprietary_name_common_name": "recombinant salmon calcitonin", "active_substance": "recombinant salmon calcitonin", "therapeutic_area_mesh": "Hypercalcemia;Osteitis Deformans;Bone Resorption", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "H05BA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Calcium homeostasis", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Calcitonin is indicated for: Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures Paget's disease Hypercalcaemia of malignancy", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Unigene UK Ltd.", "european_commission_decision_date": "20/11/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "29/10/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/11/2008", "last_updated_date": "20/11/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/forcaltonin" }, { "category": "Human", "name_of_medicine": "Viraferon", "ema_product_number": "EMEA/H/C/000282", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0059", "international_non_proprietary_name_common_name": "interferon alfa-2b", "active_substance": "interferon alfa-2b", "therapeutic_area_mesh": "Hepatitis C, Chronic;Hepatitis B, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Chronic Hepatitis B: Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis. Chronic Hepatitis C:Adult patients:IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4). The best way to use IntronA in this indication is in combination with ribavirin. Chidren and adolescents:IntronA is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA. The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load. The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Schering-Plough Europe", "european_commission_decision_date": "22/04/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/03/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/10/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "22/04/2008", "last_updated_date": "19/11/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/viraferon" }, { "category": "Human", "name_of_medicine": "Vekacia", "ema_product_number": "EMEA/H/C/000904", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "ciclosporin", "active_substance": "ciclosporin", "therapeutic_area_mesh": "Conjunctivitis, Allergic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novagali Pharma S.A.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "14/11/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "18/11/2008", "last_updated_date": "18/11/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vekacia" }, { "category": "Human", "name_of_medicine": "Exubera", "ema_product_number": "EMEA/H/C/000588", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0015", "international_non_proprietary_name_common_name": "insulin human", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AF01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "EXUBERA is indicated for the treatment of adult patients with type 2 diabetes mellitus notadequately controlled with oral antidiabetic agents and requiring insulin therapy.EXUBERA is also indicated for the treatment of adult patients with type 1 diabetes mellitus, inaddition to long or intermediate acting subcutaneous insulin, for whom the potential benefits ofadding inhaled insulin outweigh the potential safety concerns (see section 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "09/07/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "24/01/2006", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "26/09/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "09/07/2008", "last_updated_date": "16/11/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exubera" }, { "category": "Human", "name_of_medicine": "Protopy", "ema_product_number": "EMEA/H/C/000375", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0028", "international_non_proprietary_name_common_name": "tacrolimus", "active_substance": "tacrolimus", "therapeutic_area_mesh": "Dermatitis, Atopic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "D11AX14", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Other dermatological preparations", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma GmbH", "european_commission_decision_date": "03/05/2007", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/02/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/08/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "03/05/2007", "last_updated_date": "29/10/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/protopy" }, { "category": "Human", "name_of_medicine": "Vibativ", "ema_product_number": "EMEA/H/C/000864", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "telavancin", "active_substance": "telavancin", "therapeutic_area_mesh": "Skin Diseases, Infectious;Staphylococcal Infections;Soft Tissue Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma Europe B. V.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/10/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/10/2008", "last_updated_date": "24/10/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vibativ" }, { "category": "Human", "name_of_medicine": "Ellefore", "ema_product_number": "EMEA/H/C/000932", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Depressive Disorder, Major", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Wyeth Europa Ltd.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/10/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/10/2008", "last_updated_date": "15/10/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ellefore" }, { "category": "Human", "name_of_medicine": "Lacosamide Pain UCB Pharma", "ema_product_number": "EMEA/H/C/000894", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "lacosamide", "active_substance": "lacosamide", "therapeutic_area_mesh": "Diabetic Neuropathies", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma S.A.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "25/09/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/09/2008", "last_updated_date": "26/09/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lacosamide-pain-ucb-pharma" }, { "category": "Human", "name_of_medicine": "Ramelteon", "ema_product_number": "EMEA/H/C/000838", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Sleep Initiation and Maintenance Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Global Research Development Centre (Europe) Ltd.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "19/09/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/09/2008", "last_updated_date": "25/09/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ramelteon" }, { "category": "Human", "name_of_medicine": "Exulett", "ema_product_number": "EMEA/H/C/000902", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "", "therapeutic_area_mesh": "Skin Diseases, Infectious;Staphylococcal Infections;Soft Tissue Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "09/09/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/09/2008", "last_updated_date": "10/09/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exulett" }, { "category": "Human", "name_of_medicine": "Quintanrix", "ema_product_number": "EMEA/H/C/000556", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0008", "international_non_proprietary_name_common_name": "diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)", "active_substance": "Diphtheria toxoid;tetanus toxoid;inactivated Bordetella pertussis;hepatitis B surface antigen (rDNA);Haemophilus influenzae type b polysaccharide", "therapeutic_area_mesh": "Hepatitis B;Tetanus;Immunization;Meningitis, Haemophilus;Whooping Cough;Diphtheria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07CA10", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life.The use of Quintanrix should be determined on the basis of official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "11/12/2007", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/02/2005", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/08/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "11/12/2007", "last_updated_date": "10/09/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/quintanrix" }, { "category": "Human", "name_of_medicine": "Orplatna", "ema_product_number": "EMEA/H/C/000888", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "satraplatin", "active_substance": "satraplatin", "therapeutic_area_mesh": "Prostatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharmion Ltd.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "01/08/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "05/08/2008", "last_updated_date": "05/08/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orplatna" }, { "category": "Human", "name_of_medicine": "Diractin", "ema_product_number": "EMEA/H/C/000865", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "ketoprofen", "active_substance": "ketoprofen", "therapeutic_area_mesh": "Osteoarthritis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "IDEA AG", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "23/07/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/07/2008", "last_updated_date": "24/07/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/diractin" }, { "category": "Human", "name_of_medicine": "Spanidin", "ema_product_number": "EMEA/H/C/000809", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "gusperimus", "active_substance": "gusperimus trihydrochloride", "therapeutic_area_mesh": "Wegener Granulomatosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Euro Nippon Kayaku GmbH", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/06/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/06/2008", "last_updated_date": "19/06/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/spanidin" }, { "category": "Human", "name_of_medicine": "Aflunov", "ema_product_number": "EMEA/H/C/000804", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "A/VietNam/1194/2004", "active_substance": "A/VietNam/1194/2004", "therapeutic_area_mesh": "Influenza, Human;Immunization;Disease Outbreaks", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Vaccines and Diagnostics S.r.l.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/06/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/06/2008", "last_updated_date": "16/06/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aflunov-0" }, { "category": "Human", "name_of_medicine": "Lenalidomide Celgene Europe", "ema_product_number": "EMEA/H/C/000688", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "lenalidomide", "active_substance": "lenalidomide", "therapeutic_area_mesh": "Myelodysplastic Syndromes", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Celgene Europe Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "30/05/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "04/06/2008", "last_updated_date": "04/06/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-celgene-europe" }, { "category": "Human", "name_of_medicine": "Aquilda", "ema_product_number": "EMEA/H/C/000873", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "satavaptan", "active_substance": "satavaptan", "therapeutic_area_mesh": "Hyponatremia", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi-Aventis", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "23/05/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/05/2008", "last_updated_date": "28/05/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/aquilda" }, { "category": "Human", "name_of_medicine": "DuoPlavin", "ema_product_number": "EMEA/H/C/000874", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "clopidogrel;acetylsalicylic acid", "active_substance": "clopidogrel;acetylsalicylic acid", "therapeutic_area_mesh": "Vascular Surgical Procedures;Peripheral Vascular Diseases;Myocardial Infarction;Acute Coronary Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi Pharma Bristol-Myers Squibb", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "23/05/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/05/2008", "last_updated_date": "27/05/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duoplavin-0" }, { "category": "Human", "name_of_medicine": "DuoCover", "ema_product_number": "EMEA/H/C/000875", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "clopidogrel;acetylsalicylic acid", "active_substance": "clopidogrel;acetylsalicylic acid", "therapeutic_area_mesh": "Vascular Surgical Procedures;Peripheral Vascular Diseases;Myocardial Infarction;Acute Coronary Syndrome", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bristol Myers Squibb Pharma EEIG", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "23/05/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/05/2008", "last_updated_date": "27/05/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duocover" }, { "category": "Human", "name_of_medicine": "orBec", "ema_product_number": "EMEA/H/C/000803", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "beclomethasone dipropionate", "active_substance": "beclomethasone dipropionate", "therapeutic_area_mesh": "Graft vs Host Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "DOR BIOPHARMA UK Ltd", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "22/05/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/05/2008", "last_updated_date": "23/05/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orbec" }, { "category": "Human", "name_of_medicine": "Quixidar", "ema_product_number": "EMEA/H/C/000404", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "N/0034", "international_non_proprietary_name_common_name": "fondaparinux sodium", "active_substance": "fondaparinux sodium", "therapeutic_area_mesh": "Venous Thrombosis;Pulmonary Embolism;Myocardial Infarction;Angina, Unstable", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AX05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "1.5 mg/0.3 ml and 2.5 mg/0.5 ml, solution for injection: Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1). Prevention of Venous Thromboembolic Events (VTE) in medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease. 2.5 mg/0.5 ml, solution for injection: Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1). Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. 5 mg/0.4 ml, 7.5 mg/0.6 ml and 10 mg/0.8 ml solution for injection: Treatment of acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Glaxo Group Ltd.", "european_commission_decision_date": "24/10/2007", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "21/03/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "11/03/2008", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "24/10/2007", "last_updated_date": "16/05/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/quixidar" }, { "category": "Human", "name_of_medicine": "Cimzia", "ema_product_number": "EMEA/H/C/000740", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "certolizumab pegol", "active_substance": "certolizumab pegol", "therapeutic_area_mesh": "Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AB05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cimzia, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARD) including methotrexate, has been inadequate.Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "UCB Pharma SA", "european_commission_decision_date": "20/03/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "19/03/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "21/05/2008", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/03/2008", "last_updated_date": "20/03/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cimzia-0" }, { "category": "Human", "name_of_medicine": "Kiacta", "ema_product_number": "EMEA/H/C/000779", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "eprodisate disodium", "active_substance": "eprodisate disodium", "therapeutic_area_mesh": "Amyloidosis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Neurochem Luxco II SARL", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/03/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/03/2008", "last_updated_date": "17/03/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kiacta" }, { "category": "Veterinary", "name_of_medicine": "Advasure", "ema_product_number": "EMEA/V/C/000053", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "adjuvanted vaccine against classical swine fever", "active_substance": "E2 glycoprotein of classical swine fever virus", "therapeutic_area_mesh": "", "species_veterinary": "Pigs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI09AA06", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for suidae", "therapeutic_indication": "Active immunisation of pigs, over the age of 2 weeks, against Classical Swine Fever (CSF), to preventmortality, reduce clinical signs of the disease and the excretion of field virus.The onset of protection is 2 weeks.The duration of protection is 6 months.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "06/02/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "02/02/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "06/02/2008", "last_updated_date": "17/03/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/advasure" }, { "category": "Human", "name_of_medicine": "Pristiqs", "ema_product_number": "EMEA/H/C/000794", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "desvenlafaxine", "active_substance": "desvenlafaxine", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Wyeth Europe Ltd.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "10/03/2008", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "12/03/2008", "last_updated_date": "12/03/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pristiqs" }, { "category": "Human", "name_of_medicine": "Levviax", "ema_product_number": "EMEA/H/C/000355", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "A22/41", "international_non_proprietary_name_common_name": "telithromycin", "active_substance": "telithromycin", "therapeutic_area_mesh": "Community-Acquired Infections;Pharyngitis;Bronchitis, Chronic;Pneumonia;Tonsillitis;Sinusitis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J01FA15", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antibacterials for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "When prescribing Levviax consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).Levviax is indicated for the treatment of the following infections:In patients of 18 years and older:-Community-acquired pneumonia, mild or moderate (see section 4.4).- When treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):- Acute exacerbation of chronic bronchitis,- Acute sinusitisIn patients of 12 years and older:- Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Aventis Pharma S.A.", "european_commission_decision_date": "31/05/2007", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/07/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/07/2001", "suspension_of_marketing_authorisation_date": "", "revision_number": "10", "first_published_date": "31/05/2007", "last_updated_date": "14/02/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levviax" }, { "category": "Human", "name_of_medicine": "Monotard", "ema_product_number": "EMEA/H/C/000440", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "C/0440", "international_non_proprietary_name_common_name": "insulin human (rDNA)", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AC01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "25/04/2002", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/10/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "14/11/2006", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/04/2002", "last_updated_date": "14/02/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/monotard" }, { "category": "Human", "name_of_medicine": "Trudexa", "ema_product_number": "EMEA/H/C/000482", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "II/0037", "international_non_proprietary_name_common_name": "adalimumab", "active_substance": "adalimumab", "therapeutic_area_mesh": "Spondylitis, Ankylosing;Arthritis, Rheumatoid;Arthritis, Psoriatic;Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L04AA17", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunosuppressants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rheumatoid arthritisTrudexa in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Trudexa has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Psoriatic arthritisTrudexa is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Ankylosing spondylitisTrudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Crohn's diseaseTrudexa is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. For induction treatment, Trudexa should be given in combination with cortiocosteroids. Trudexa can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Abbott Laboratories Ltd.", "european_commission_decision_date": "29/06/2007", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/09/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/07/2007", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "29/06/2007", "last_updated_date": "14/02/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/trudexa" }, { "category": "Human", "name_of_medicine": "Ultratard", "ema_product_number": "EMEA/H/C/000439", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "insulin human (rDNA)", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of diabetes mellitus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "european_commission_decision_date": "07/10/2002", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/10/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "14/11/2006", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "07/10/2002", "last_updated_date": "14/02/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ultratard" }, { "category": "Human", "name_of_medicine": "Natalizumab Elan Pharma", "ema_product_number": "EMEA/H/C/000624", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "natalizumab", "active_substance": "natalizumab", "therapeutic_area_mesh": "Crohn Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AD", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of moderately to severely active Crohn's disease for the reduction of signs and symptoms, and the induction and maintenance of sustained response and remission, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or are intolerant to or have medical contraindications to such therapies.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Elan Pharma International Ltd.", "european_commission_decision_date": "25/01/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "15/11/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "11/01/2008", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "25/01/2008", "last_updated_date": "25/01/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/natalizumab-elan-pharma" }, { "category": "Human", "name_of_medicine": "Mylotarg", "ema_product_number": "EMEA/H/C/000705", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "gemtuzumab ozogamicin", "active_substance": "gemtuzumab ozogamicin", "therapeutic_area_mesh": "Leukemia, Myeloid, Acute", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01XC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "re-induction treatment of CD33-positive AML adult patients in first relapse who are not candidates for other intensive re-induction chemotherapy regimens (e.g. high-dose Ara-C) and meet at least one of the following criteria: duration of first remission <12 months, or age >60 years.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Wyeth Europa Ltd", "european_commission_decision_date": "24/01/2008", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "24/01/2008", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "14/04/2008", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/01/2008", "last_updated_date": "24/01/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mylotarg-0" }, { "category": "Human", "name_of_medicine": "Insulin Human Rapid Marvel", "ema_product_number": "EMEA/H/C/000845", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "insulin human", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Marvel LifeSciences Ltd.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/12/2007", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/01/2008", "last_updated_date": "16/01/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-human-rapid-marvel" }, { "category": "Human", "name_of_medicine": "Insulin Human Long Marvel", "ema_product_number": "EMEA/H/C/000846", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "insulin human", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Marvel LifeSciences Ltd.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/12/2007", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/01/2008", "last_updated_date": "16/01/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-human-long-marvel" }, { "category": "Human", "name_of_medicine": "Insulin Human 30/70 Mix Marvel", "ema_product_number": "EMEA/H/C/000847", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "insulin human", "active_substance": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Marvel LifeSciences Ltd.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "20/12/2007", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/01/2008", "last_updated_date": "16/01/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-human-30-70-mix-marvel" }, { "category": "Human", "name_of_medicine": "Sinerem", "ema_product_number": "EMEA/H/C/000801", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "iron oxide", "active_substance": "iron oxide", "therapeutic_area_mesh": "Magnetic Resonance Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Guerbet", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/12/2007", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "14/12/2007", "last_updated_date": "14/12/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/sinerem" }, { "category": "Human", "name_of_medicine": "Gastromotal", "ema_product_number": "EMEA/H/C/000724", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "1-13C-caprylic acid", "active_substance": "1-13C-caprylic acid", "therapeutic_area_mesh": "Gastric Emptying;Breath Tests", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "INFAI, Institut für biomedizinische Analytik NMR-Imaging GmbH", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "05/11/2007", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/11/2007", "last_updated_date": "16/11/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/gastromotal" }, { "category": "Human", "name_of_medicine": "Garenoxacin mesylate", "ema_product_number": "EMEA/H/C/000747", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "garenoxacin mesylate", "active_substance": "garenoxacin mesylate", "therapeutic_area_mesh": "Surgical Wound Infection;Sinusitis;Skin Diseases, Infectious;Pneumonia;Soft Tissue Infections;Bronchitis, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Schering-Plough Europe", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "25/07/2007", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/07/2007", "last_updated_date": "26/07/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/garenoxacin-mesylate" }, { "category": "Human", "name_of_medicine": "Retisert", "ema_product_number": "EMEA/H/C/000787", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "fluocinolone acetonide", "active_substance": "Fluocinolone acetonide", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bausch Lomb Ireland", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "16/07/2007", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/07/2007", "last_updated_date": "23/07/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/retisert" }, { "category": "Human", "name_of_medicine": "Cerepro", "ema_product_number": "EMEA/H/C/000694", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "", "active_substance": "adenovirus-mediated Herpes simplex virus-thymidine kinase gene", "therapeutic_area_mesh": "Glioma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Ark Therapeutics", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/07/2007", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/07/2007", "last_updated_date": "20/07/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cerepro-0" }, { "category": "Human", "name_of_medicine": "Voraxaze", "ema_product_number": "EMEA/H/C/000681", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "glucarpidase", "active_substance": "glucarpidase", "therapeutic_area_mesh": "", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Protherics PLC", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "21/05/2007", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "29/05/2007", "last_updated_date": "29/05/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/voraxaze-0" }, { "category": "Human", "name_of_medicine": "Vitragan", "ema_product_number": "EMEA/H/C/000696", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "hyaluronidase", "active_substance": "hyaluronidase", "therapeutic_area_mesh": "Vitreous Hemorrhage", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "ISTA Pharma Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "25/04/2007", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/04/2007", "last_updated_date": "30/04/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vitragan" }, { "category": "Human", "name_of_medicine": "Iplex", "ema_product_number": "EMEA/H/C/000754", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "mecasermin rinfabate", "active_substance": "mecasermin rinfabate", "therapeutic_area_mesh": "Dwarfism, Pituitary", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Insmed Europe Ltd", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "26/03/2007", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "26/03/2007", "last_updated_date": "26/03/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/iplex" }, { "category": "Human", "name_of_medicine": "Mycograb", "ema_product_number": "EMEA/H/C/000658", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "efungumab", "active_substance": "recombinant human monoclonal antibody to hsp", "therapeutic_area_mesh": "Candidiasis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antimycotics for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of invasive candidiasis in adult patients, in combination with amphotericin B or a lipid formulation of amphotericin B.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "NeuTec Pharma plc", "european_commission_decision_date": "21/03/2007", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/03/2007", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "22/05/2007", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "21/03/2007", "last_updated_date": "21/03/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mycograb" }, { "category": "Human", "name_of_medicine": "Arxxant", "ema_product_number": "EMEA/H/C/000753", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "ruboxistaurin", "active_substance": "", "therapeutic_area_mesh": "Diabetic Retinopathy", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Nederland B.V.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/03/2007", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "15/03/2007", "last_updated_date": "15/03/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/arxxant" }, { "category": "Veterinary", "name_of_medicine": "Veraflox", "ema_product_number": "EMEA/V/C/000099", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pradofloxacin", "active_substance": "pradofloxacin", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QJ01MA", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "Dogs:Infections of the skin and soft tissues, i.e. superficial and deep pyoderma and wound infections caused by Gram-positive organisms, typically Staphylococcus spp. and Streptococcus spp., and Gram-negative organisms such as Escherichia coli, Pseudomonas spp. and Proteus spp.Infections of the urinary tract caused by Gram-negative bacteria such as enterobacteriaceae, e.g. Escherichia coli, Enterobacter spp., Klebsiella spp. and Proteus spp., Pseudomonas spp., and Gram-positive organisms, typically Staphylococcus spp.Infections of the gingiva and periodontal tissues caused by anaerobic organisms, for example Porphyromonas spp., Prevotella spp.; Fusobacterium spp., Eikenella spp. and capnophilic bacteria such as Capnocytophaga spp. Cats:Infections of the respiratory tract caused by Gram-negative organisms such as Pasteurella spp., Escherichia coli and Pseudomonas spp., and Gram-positive organisms such as Streptococcus spp. and Staphylococcus spp.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Bayer HealthCare AG", "european_commission_decision_date": "24/01/2007", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "14/09/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "11/12/2006", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/01/2007", "last_updated_date": "24/01/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/veraflox-0" }, { "category": "Human", "name_of_medicine": "Synordia", "ema_product_number": "EMEA/H/C/000768", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "fenofibrate;metformin", "active_substance": "fenofibrate;metformin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Fournier Laboratories Ireland Ltd.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "07/12/2006", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/12/2006", "last_updated_date": "08/12/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/synordia" }, { "category": "Human", "name_of_medicine": "Riquent", "ema_product_number": "EMEA/H/C/000733", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "abetimus", "active_substance": "abetimus", "therapeutic_area_mesh": "Lupus Nephritis", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "La Jolla Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "13/10/2006", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/10/2006", "last_updated_date": "13/10/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/riquent" }, { "category": "Human", "name_of_medicine": "Multaq", "ema_product_number": "EMEA/H/C/000676", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "dronedarone", "active_substance": "dronedarone", "therapeutic_area_mesh": "Atrial Fibrillation;Atrial Flutter", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sanofi-Aventis", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "06/09/2006", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/09/2006", "last_updated_date": "08/09/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/multaq-0" }, { "category": "Human", "name_of_medicine": "Fortovase", "ema_product_number": "EMEA/H/C/000178", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "saquinavir", "active_substance": "saquinavir", "therapeutic_area_mesh": "HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AE01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Fortovase is indicated for treatment of HIV-1 infected adult patients. Fortovase should only be given in combination with ritonavir and other antiretroviral medicinal products (see section 4.2).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration Ltd.", "european_commission_decision_date": "20/08/1998", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "20/08/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/06/2006", "suspension_of_marketing_authorisation_date": "", "revision_number": "11", "first_published_date": "20/08/1998", "last_updated_date": "07/08/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fortovase" }, { "category": "Human", "name_of_medicine": "Thymanax", "ema_product_number": "EMEA/H/C/000657", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "agomelatine", "active_substance": "agomelatine", "therapeutic_area_mesh": "Depressive Disorder, Major", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "27/07/2006", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/07/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "16/01/2007", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/07/2006", "last_updated_date": "27/07/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/thymanax-0" }, { "category": "Human", "name_of_medicine": "Valdoxan", "ema_product_number": "EMEA/H/C/000656", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "agomelatine", "active_substance": "agomelatine", "therapeutic_area_mesh": "Depressive Disorder, Major", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Les Laboratoires Servier", "european_commission_decision_date": "27/07/2006", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "27/07/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "16/01/2007", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/07/2006", "last_updated_date": "27/07/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/valdoxan-0" }, { "category": "Human", "name_of_medicine": "Alpheon", "ema_product_number": "EMEA/H/C/000585", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "interferon alfa-2a", "active_substance": "recombinant human interferon alfa-2a", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Adult patients with histologically proven chronic hepatitis C who are positive for hepatitis C virus (HCV) antibodies or HCV RNA and have elevated serum alanine aminotransferase (ALT) without liver decompensation.The efficacy of Interferon alfa-2a in the treatment of hepatitis C is enhanced when combined with ribavirin. Alpheon should be given alone mainly in case of intolerance or contra-indication to ribavirin.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "Yes", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "BioPartners GmbH", "european_commission_decision_date": "28/06/2006", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "28/06/2006", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "05/09/2006", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/06/2006", "last_updated_date": "28/06/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/alpheon" }, { "category": "Human", "name_of_medicine": "Surfaxin", "ema_product_number": "EMEA/H/C/000625", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "sinapultide;dipalmitoylphosphatidylcholine;palmitoyl-oleoyl phosphatidylglycerol;palmitic acid", "active_substance": "sinapultide;Dipalmitoylphosphatidylcholine;palmitoyl-oleoyl phosphatidylglycerol;palmitic acid", "therapeutic_area_mesh": "Respiratory Distress Syndrome, Newborn", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharm Research Associates (UK) Limited", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "07/06/2006", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "08/06/2006", "last_updated_date": "08/06/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/surfaxin" }, { "category": "Human", "name_of_medicine": "Infergen", "ema_product_number": "EMEA/H/C/000186", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "interferon alfacon-1", "active_substance": "interferon alfacon-1", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AB09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of patients of 18 years and older with chronic hepatitis and serum markers for hepatitis C virus (HCV) infection e.g. those who have elevated serum transaminase levels without decompensated liver disease and who are positive for serum HCV-RNA (see section 4.4). Consideration should be given to current official guidance on the appropriate use of interferons for the treatment of patients with chronic hepatitis C.Interferon alfacon-1 should be given alone mainly in case of intolerance or contraindication to ribavirin.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Astellas Pharma Europe B.V.", "european_commission_decision_date": "05/05/2006", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/02/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "05/05/2006", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "05/05/2006", "last_updated_date": "01/06/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/infergen" }, { "category": "Human", "name_of_medicine": "Uprima", "ema_product_number": "EMEA/H/C/000327", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "apomorphine", "active_substance": "apomorphine hydrochloride", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.In order for Uprima to be effective, sexual stimulation is required.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Abbott Laboratories Ltd.", "european_commission_decision_date": "29/05/2006", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/05/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/05/2006", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "29/05/2006", "last_updated_date": "29/05/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/uprima" }, { "category": "Human", "name_of_medicine": "Daquiran", "ema_product_number": "EMEA/H/C/000135", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "pramipexole", "active_substance": "pramipexole dihydrochloride monohydrate", "therapeutic_area_mesh": "Parkinson Disease", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N04BC05", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Anti-Parkinson drugs", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "DAQUIRAN tablets are indicated for treatment of the signs and symptoms of advanced idiopathic Parkinson's disease in combination with levodopa, i.e. over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or \"on off\" fluctuations).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dr. Karl Thomae GmbH", "european_commission_decision_date": "02/02/2006", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/10/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "02/02/2006", "suspension_of_marketing_authorisation_date": "", "revision_number": "5", "first_published_date": "02/02/2006", "last_updated_date": "23/05/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/daquiran" }, { "category": "Human", "name_of_medicine": "Scintimun", "ema_product_number": "EMEA/H/C/000653", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "besilesomab", "active_substance": "besilesomab", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "CIS bio international", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "17/05/2006", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/05/2006", "last_updated_date": "22/05/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/scintimun-0" }, { "category": "Human", "name_of_medicine": "Retaane", "ema_product_number": "EMEA/H/C/000635", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "anecortave acetate", "active_substance": "anecortave acetate", "therapeutic_area_mesh": "Wet Macular Degeneration", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Alcon Laboratories (U.K.) Limited.", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "28/02/2006", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "02/03/2006", "last_updated_date": "02/03/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/retaane" }, { "category": "Human", "name_of_medicine": "Theryttrex", "ema_product_number": "EMEA/H/C/000445", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "yttrium [90Y] chloride", "active_substance": "yttrium (90Y) chloride", "therapeutic_area_mesh": "Radionuclide Imaging", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "To be used only for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.Radiopharmaceutical precursor - Not intended for direct application to patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "MDS Nordion S.A.", "european_commission_decision_date": "02/02/2006", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/01/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "02/02/2006", "suspension_of_marketing_authorisation_date": "", "revision_number": "1", "first_published_date": "02/02/2006", "last_updated_date": "02/03/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/theryttrex" }, { "category": "Human", "name_of_medicine": "Ximelagatran 36 mg film coated tablets", "ema_product_number": "EMEA/H/C/000702", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "ximelagatran", "active_substance": "ximelagatran", "therapeutic_area_mesh": "Atrial Fibrillation", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "AstraZeneca", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "14/02/2006", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "16/02/2006", "last_updated_date": "16/02/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ximelagatran-36-mg-film-coated-tablets" }, { "category": "Human", "name_of_medicine": "Orathecin", "ema_product_number": "EMEA/H/C/000608", "medicine_status": "Application withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "-", "international_non_proprietary_name_common_name": "rubitecan", "active_substance": "rubitecan", "therapeutic_area_mesh": "Pancreatic Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "Yes", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "EuroGen Pharmaceuticals Ltd", "european_commission_decision_date": "31/12/2009", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "19/01/2006", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/01/2006", "last_updated_date": "23/01/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orathecin" }, { "category": "Human", "name_of_medicine": "Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KG", "ema_product_number": "EMEA/H/C/000307", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "tenecteplase", "active_substance": "tenecteplase", "therapeutic_area_mesh": "Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AD", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KG is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Boehringer Ingelheim International GmbH", "european_commission_decision_date": "09/08/2005", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "23/02/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "09/08/2005", "suspension_of_marketing_authorisation_date": "", "revision_number": "2", "first_published_date": "09/08/2005", "last_updated_date": "05/12/2005", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/tenecteplase-boehringer-ingelheim-pharma-gmbh-co-kg" }, { "category": "Human", "name_of_medicine": "CEA-Scan", "ema_product_number": "EMEA/H/C/000041", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "arcitumomab", "active_substance": "arcitumomab", "therapeutic_area_mesh": "Radionuclide Imaging;Colorectal Neoplasms", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09IA01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "CEA-Scan is indicated only in patients with histologically-demonstrated carcinoma of the colon or rectum for imaging of recurrence and/or metastases. CEA-Scan is employed for diagnostic use only, in the above mentioned patients, as an adjunct to standard non-invasive imaging techniques, such as ultrasonography or CT scan, in the following situations: Patients with evidence of recurrence and/or metastatic carcinoma of the colon or rectum, who are undergoing an evaluation for extent of disease, such as prior to surgical resection and/or other therapy, or Patients with suspected recurrence and/or metastatic carcinoma of the colon or rectum in association with rising levels of carcinoembryonic antigen (CEA).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Immunomedics GmbH", "european_commission_decision_date": "26/09/2005", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/10/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/09/2005", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "26/09/2005", "last_updated_date": "16/11/2005", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cea-scan" }, { "category": "Human", "name_of_medicine": "Rayzon", "ema_product_number": "EMEA/H/C/000382", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "parecoxib", "active_substance": "parecoxib", "therapeutic_area_mesh": "Pain, Postoperative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M01AH04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiinflammatory and antirheumatic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the short-term treatment of postoperative pain.The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3, 4.4).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharmacia Europe EEIG", "european_commission_decision_date": "24/06/2005", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/03/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "24/06/2005", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "24/06/2005", "last_updated_date": "23/08/2005", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rayzon" }, { "category": "Human", "name_of_medicine": "Patrex", "ema_product_number": "EMEA/H/C/000204", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "sildenafil", "active_substance": "sildenafil", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Patrex to be effective, sexual stimulation is required. Patrex is not indicated for use by women.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "15/09/2003", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/09/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "15/09/2003", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "15/09/2003", "last_updated_date": "18/08/2005", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/patrex" }, { "category": "Human", "name_of_medicine": "Valdyn (previously Kudeq)", "ema_product_number": "EMEA/H/C/000437", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "valdecoxib", "active_substance": "valdecoxib", "therapeutic_area_mesh": "Arthritis, Rheumatoid;Osteoarthritis;Dysmenorrhea", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M01AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiinflammatory and antirheumatic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "24/06/2005", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/03/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "25/06/2005", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/06/2005", "last_updated_date": "11/08/2005", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/valdyn-0" }, { "category": "Human", "name_of_medicine": "Infanrix HepB", "ema_product_number": "EMEA/H/C/000126", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "diphtheria, tetanus, acellular pertussis and hepatitis B recombinant, adsorbed vaccine", "active_substance": "Diphtheria toxoid;tetanus toxoid;pertussis toxoid;pertussis haemagglutin filamentous;pertactin;hepatitis B recombinant surface antigen", "therapeutic_area_mesh": "Hepatitis B;Tetanus;Immunization;Whooping Cough;Diphtheria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07CA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Infanrix HepB is indicated for active immunisation of all infants from the age of 2 months againstdiphtheria, tetanus, pertussis and hepatitis B.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "GlaxoSmithKline Biologicals S.A.", "european_commission_decision_date": "25/04/2005", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/07/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "3", "first_published_date": "25/04/2005", "last_updated_date": "04/08/2005", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/infanrix-hepb" }, { "category": "Human", "name_of_medicine": "Venvia", "ema_product_number": "EMEA/H/C/000270", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rosiglitazone", "active_substance": "rosiglitazone", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rosiglitazone is indicated as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Rosiglitazone is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or a sulphonylurea: in combination with metformin particularly in overweight patients. in combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SmithKline Beecham Plc", "european_commission_decision_date": "25/11/2004", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/07/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "08/12/2004", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "25/11/2004", "last_updated_date": "18/04/2005", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/venvia" }, { "category": "Human", "name_of_medicine": "Nyracta", "ema_product_number": "EMEA/H/C/000269", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "rosiglitazone", "active_substance": "rosiglitazone", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10BG02", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Rosiglitazone is indicated as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Rosiglitazone is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or a sulphonylurea:- in combination with metformin particularly in overweight patients.­- in combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "SmithKline Beecham Plc", "european_commission_decision_date": "08/12/2004", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/07/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "08/12/2004", "suspension_of_marketing_authorisation_date": "", "revision_number": "6", "first_published_date": "08/12/2004", "last_updated_date": "18/04/2005", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nyracta" }, { "category": "Human", "name_of_medicine": "Taluvian", "ema_product_number": "EMEA/H/C/000386", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "apomorphine", "active_substance": "apomorphine hydrochloride", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.In order for Taluvian to be effective, sexual stimulation is required.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Abbott S.r.l.", "european_commission_decision_date": "13/07/2004", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/05/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "13/07/2004", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "13/07/2004", "last_updated_date": "10/11/2004", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/taluvian" }, { "category": "Human", "name_of_medicine": "Ixense", "ema_product_number": "EMEA/H/C/000328", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "apomorphine", "active_substance": "apomorphine hydrochloride", "therapeutic_area_mesh": "Erectile Dysfunction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "G04BE", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Urologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.In order for Ixense to be effective, sexual stimulation is required.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Takeda Europe R Centre Ltd.", "european_commission_decision_date": "28/09/2004", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "28/05/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/09/2004", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/09/2004", "last_updated_date": "10/11/2004", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ixense" }, { "category": "Veterinary", "name_of_medicine": "Doxirobe", "ema_product_number": "EMEA/V/C/000044", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "doxycycline", "active_substance": "doxycycline", "therapeutic_area_mesh": "", "species_veterinary": "Dogs", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QJ01AA02", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Antibacterials for systemic use", "therapeutic_indication": "Treatment of periodontal disease in dogs.Periodontal pocket probing depths >=4 mm are evidence of disease that may be responsive to treatment with the Doxirobe Gel. Use of this product as directed should result in attachment level gains, periodontal pocket depth reductions, local antimicrobial effect and improved gingival health. Noticeable improvements in these parameters should be evident within 2-4 weeks following treatment. The response in individual dogs is dependent on the severity of the condition and rigor of adjunctive therapy.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pfizer Limited", "european_commission_decision_date": "01/12/2003", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "16/09/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "01/12/2003", "last_updated_date": "16/09/2004", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/doxirobe" }, { "category": "Human", "name_of_medicine": "Xapit", "ema_product_number": "EMEA/H/C/000380", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "parecoxib", "active_substance": "parecoxib", "therapeutic_area_mesh": "Pain, Postoperative", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M01AH04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiinflammatory and antirheumatic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the short-term treatment of postoperative pain.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharmacia Europe EEIG", "european_commission_decision_date": "01/03/2004", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "22/03/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "02/03/2004", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "01/03/2004", "last_updated_date": "23/08/2004", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/xapit" }, { "category": "Human", "name_of_medicine": "Valdyn", "ema_product_number": "EMEA/H/C/000432", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "valdecoxib", "active_substance": "valdecoxib", "therapeutic_area_mesh": "Osteoarthritis;Arthritis, Rheumatoid;Dysmenorrhea", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "M01AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antiinflammatory and antirheumatic products", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharmacia Europe EEIG", "european_commission_decision_date": "02/03/2004", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "27/03/2003", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "02/03/2004", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "02/03/2004", "last_updated_date": "23/08/2004", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/valdyn" }, { "category": "Veterinary", "name_of_medicine": "Eurifel RCP FeLV", "ema_product_number": "EMEA/V/C/000067", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "vaccine against feline viral rhinotracheitis, calicivirosis, panleucopenia and leukaemia in cats", "active_substance": "canarypox virus expressing feline leukemia virus, live;feline calicivirus, strain 255, inactivated;feline panleucopenia virus, strain PLI IV, live;feline rhinotracheitis virus, strain C27, antigen", "therapeutic_area_mesh": "", "species_veterinary": "Cats", "patient_safety": "No", "atc_code_human": "", "atcvet_code_veterinary": "QI06AH", "pharmacotherapeutic_group_human": "", "pharmacotherapeutic_group_veterinary": "Immunologicals for felidae", "therapeutic_indication": "Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia. Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, feline panleucopenia virus and feline leukaemia virus. The feline leukaemia vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A. Under field conditions, only sub-group A is infective and immunisation against subgroup A provides full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but does not replicate in the cat. As a consequence, the vaccine induces an immune status against feline leukaemia virus.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Merial", "european_commission_decision_date": "23/07/2004", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "08/03/2002", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "8", "first_published_date": "23/07/2004", "last_updated_date": "23/07/2004", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/EPAR/eurifel-rcp-felv" }, { "category": "Human", "name_of_medicine": "Opulis", "ema_product_number": "EMEA/H/C/000311", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "desloratadine", "active_substance": "desloratadine", "therapeutic_area_mesh": "Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "R06AX27", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antihistamines for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Opulis is indicated for the relief of symptoms associated with:- allergic rhinitis (see section 5.1)- urticaria (see section 5.1)", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Schering-Plough Europe", "european_commission_decision_date": "10/03/2004", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/01/2001", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "10/03/2004", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "10/03/2004", "last_updated_date": "19/05/2004", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opulis" }, { "category": "Human", "name_of_medicine": "Cotronak", "ema_product_number": "EMEA/H/C/000247", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ribavirin", "active_substance": "ribavirin", "therapeutic_area_mesh": "Hepatitis C, Chronic", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Cotronak is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b. Cotronak monotherapy must not be used.There is no safety or efficacy information on the use of Cotronak with other forms of interferon (i.e., not alfa-2b).Please refer also to the peginterferon alfa-2b or interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Schering-Plough Europe", "european_commission_decision_date": "01/03/2004", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/05/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "4", "first_published_date": "01/03/2004", "last_updated_date": "01/03/2004", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cotronak" }, { "category": "Human", "name_of_medicine": "HumaSPECT", "ema_product_number": "EMEA/H/C/000145", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "votumumab", "active_substance": "votumumab", "therapeutic_area_mesh": "Ultrasonography;Colorectal Neoplasms;Tomography, X-Ray Computed", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V09IX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic radiopharmaceuticals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "After reconstitution with sodium pertechnetate [99mTc] solution, HumaSPECT [99mTc] is indicated in patients with histologically proven carcinoma of the colon or rectum for imaging of recurrence and/or metastases. HumaSPECT [99mTc] is employed, in the above mentioned patients, as an adjunct to standard non invasive imaging techniques, such as ultrasonography or CT scan, in the following situations.• Patients with evidence of recurrence and/or metastatic carcinoma of the colon or rectum, who are undergoing an evaluation for extent of disease, such as prior to surgical resection and/or other therapy.• Patients with suspected recurrence and/or metastatic carcinoma of the colon or rectum in association with rising levels of carcinoembryonic antigen (CEA).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "KS Biomedix Limited", "european_commission_decision_date": "24/09/2003", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "25/09/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "24/09/2003", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "24/09/2003", "last_updated_date": "23/02/2004", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/humaspect" }, { "category": "Human", "name_of_medicine": "Yondelis", "ema_product_number": "EMEA/H/C/000464", "medicine_status": "Refused", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "trabectedin", "active_substance": "trabectedin", "therapeutic_area_mesh": "Sarcoma", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L01CX01", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antineoplastic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Yondelis is indicated for the treatment of patients with advanced soft tissue sarcoma, having failed antracyclines and ifosfamide, or having failed ifosfamide and unsuitable to receive antracyclines/ifosfamide.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pharma Mar S.A.", "european_commission_decision_date": "20/11/2003", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "20/11/2003", "withdrawal_of_application_date": "", "marketing_authorisation_date": "", "refusal_of_marketing_authorisation_date": "07/09/2004", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "20/11/2003", "last_updated_date": "20/11/2003", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yondelis-0" }, { "category": "Human", "name_of_medicine": "Olansek", "ema_product_number": "EMEA/H/C/000114", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "olanzapine", "active_substance": "olanzapine", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N05AH03", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Psycholeptics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Olanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode. Olanzapine has not been demonstrated to prevent recurrence of manic or depressive episodes (see Section 5.1).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly Co. Ltd.", "european_commission_decision_date": "17/03/2003", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/10/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "17/03/2003", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "17/03/2003", "last_updated_date": "12/06/2003", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/olansek" }, { "category": "Human", "name_of_medicine": "Hepacare", "ema_product_number": "EMEA/H/C/000261", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "hepatitis B surface antigens recombinant (S, pre-S1, pre-S2) adsorbed on aluminium hydroxide [produced on genetically engineered murine (C127I) cells]", "active_substance": "hepatitis B surface antigens recombinant (S, pre-S1, pre-S2) adsorbed on aluminium hydroxide [produced on genetically engineered murine (C127I) cells]", "therapeutic_area_mesh": "Hepatitis B;Immunization", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07BC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This vaccine is indicated for active immunisation against hepatitis B virus infection in non-immune adults (>=18 years). The specific at risk categories to be immunised are to be determined on the basis of official recommendations.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Evans Vaccines Ltd.", "european_commission_decision_date": "23/10/2002", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "04/08/2000", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "23/10/2002", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "23/10/2002", "last_updated_date": "17/12/2002", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hepacare" }, { "category": "Human", "name_of_medicine": "Vitravene", "ema_product_number": "EMEA/H/C/000244", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "fomivirsen", "active_substance": "fomivirsen", "therapeutic_area_mesh": "Cytomegalovirus Retinitis;HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "S01AD08", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Ophthalmologicals", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immuno-deficiency syndrome (AIDS). Until further experience is gained, fomivirsen should be used only when other therapy has been ineffective or is considered unsuitable.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Novartis Ophthalmics Europe Ltd.", "european_commission_decision_date": "30/07/2002", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/07/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "30/07/2002", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/07/2002", "last_updated_date": "07/08/2002", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vitravene" }, { "category": "Human", "name_of_medicine": "Zartra", "ema_product_number": "EMEA/H/C/000180", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "imiquimod", "active_substance": "imiquimod", "therapeutic_area_mesh": "Condylomata Acuminata", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "L03AX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Immunostimulants", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Imiquimod cream is indicated for the topical treatment of external genital and perianal warts (condyloma acuminata) in adult patients.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Laboratoires 3M Santé", "european_commission_decision_date": "11/06/2002", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/09/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "11/06/2002", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/06/2002", "last_updated_date": "31/07/2002", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zartra" }, { "category": "Human", "name_of_medicine": "Triacelluvax", "ema_product_number": "EMEA/H/C/000181", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed)", "active_substance": "Diphtheria toxoid;haemagglutinin filamentous;pertussis pertactin;pertussis toxin;tetanus toxoid", "therapeutic_area_mesh": "Immunization;Tetanus;Whooping Cough;Diphtheria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07AJ", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "TRIACELLUVAX is indicated for active immunisation of children from 6 weeks up to 7 years of age against diphtheria, tetanus and pertussis.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Chiron S.p.A.", "european_commission_decision_date": "28/01/2002", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "11/01/1999", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "28/01/2002", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "28/01/2002", "last_updated_date": "03/07/2002", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/triacelluvax" }, { "category": "Human", "name_of_medicine": "Orlaam", "ema_product_number": "EMEA/H/C/000077", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "levacetylmethadol", "active_substance": "levacetylmethadol", "therapeutic_area_mesh": "Opioid-Related Disorders", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "N02AC", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Analgesics", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "ORLAAM is indicated for the substitution maintenance treatment of opiate addiction in adults previously treated with methadone, as part of a comprehensive treatment plan including medical, social and psychological care. ORLAAM should be administered under the supervision of physicians with experience in addiction treatment and whenever practicable, in centres specialising in the treatment of drug addiction. ORLAAM is not intended for take home use.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sipaco Internacional Lda.", "european_commission_decision_date": "11/06/2002", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "01/07/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "11/06/2002", "last_updated_date": "30/06/2002", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/orlaam" }, { "category": "Human", "name_of_medicine": "Vitrasert Implant", "ema_product_number": "EMEA/H/C/000120", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "ganciclovir", "active_substance": "ganciclovir", "therapeutic_area_mesh": "Cytomegalovirus Retinitis;HIV Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J05AB06", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "The Vitrasert implant is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (See 4.4. Special warnings and special precautions for use).", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH..", "european_commission_decision_date": "02/04/2002", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "18/03/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "02/04/2002", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "02/04/2002", "last_updated_date": "13/05/2002", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/vitrasert-implant" }, { "category": "Human", "name_of_medicine": "Liprolog", "ema_product_number": "EMEA/H/C/000143", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "insulin lispro", "active_substance": "insulin lispro", "therapeutic_area_mesh": "Diabetes Mellitus", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "A10AB04", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Drugs used in diabetes;Insulins and analogues for injection, fast-acting", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "For the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilization of diabetes mellitus. Liprolog is a short acting insulin and may be used in conjunction with a longer acting human insulin. Liprolog is indicated for preprandial administration.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Eli Lilly and Company Limited", "european_commission_decision_date": "19/02/2001", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "07/05/1997", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "19/02/2001", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "19/02/2001", "last_updated_date": "01/08/2001", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/liprolog-0" }, { "category": "Human", "name_of_medicine": "EchoGen", "ema_product_number": "EMEA/H/C/000149", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "dodecafluoropentane", "active_substance": "dodecafluoropentane", "therapeutic_area_mesh": "Echocardiography", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V08DA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Contrast media", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "EchoGen is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left ventricular border delineation with resulting improvement in wall motion visualisation. EchoGen should only be used in patients where the study without contrast enhancement is inconclusive.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Sonus Pharmaceuticals Ltd.", "european_commission_decision_date": "22/01/2001", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "17/07/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "22/01/2001", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "22/01/2001", "last_updated_date": "22/05/2001", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/echogen" }, { "category": "Human", "name_of_medicine": "Ecokinase", "ema_product_number": "EMEA/H/C/000106", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "reteplase", "active_substance": "reteplase", "therapeutic_area_mesh": "Myocardial Infarction", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "B01AD07", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Antithrombotic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Thrombolytic therapy of acute myocardial infarction", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Roche Registration Ltd.", "european_commission_decision_date": "30/07/1999", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "29/08/1996", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "30/07/1999", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "30/07/1999", "last_updated_date": "12/12/2000", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ecokinase" }, { "category": "Human", "name_of_medicine": "Primavax", "ema_product_number": "EMEA/H/C/000156", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "diphtheria, tetanus and hepatitis B (rDNA) vaccine (adsorbed)", "active_substance": "Diphtheria toxoid;hepatitis B, recombinant surface antigen;tetanus toxoid", "therapeutic_area_mesh": "Hepatitis B;Tetanus;Immunization;Diphtheria", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "J07CA", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Vaccines", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "This vaccine is indicated for active immunization against hepatitis B, caused by all known subtypes, diphtheria and tetanus in infants :- for primary vaccination- for boosteraccording to national vaccination policies.This vaccine should not be administered to neonates.This vaccine is not intended for use in adolescents or adults.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Pasteur Mà¨rieux MSD", "european_commission_decision_date": "27/07/2000", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "05/02/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "27/07/2000", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "27/07/2000", "last_updated_date": "04/12/2000", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/primavax" }, { "category": "Human", "name_of_medicine": "Pylori-Chek", "ema_product_number": "EMEA/H/C/000182", "medicine_status": "Withdrawn", "opinion_status": "", "latest_procedure_affecting_product_information": "", "international_non_proprietary_name_common_name": "13C-urea", "active_substance": "urea (13C)", "therapeutic_area_mesh": "Breath Tests;Helicobacter Infections", "species_veterinary": "", "patient_safety": "No", "atc_code_human": "V04CX", "atcvet_code_veterinary": "", "pharmacotherapeutic_group_human": "Diagnostic agents", "pharmacotherapeutic_group_veterinary": "", "therapeutic_indication": "Pylori-Chek may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection.", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "Alimenterics B.V.", "european_commission_decision_date": "05/07/2000", "start_of_rolling_review_date": "", "start_of_evaluation_date": "", "opinion_adopted_date": "", "withdrawal_of_application_date": "", "marketing_authorisation_date": "15/06/1998", "refusal_of_marketing_authorisation_date": "", "withdrawal_expiry_revocation_lapse_of_marketing_authorisation_date": "05/07/2000", "suspension_of_marketing_authorisation_date": "", "revision_number": "", "first_published_date": "05/07/2000", "last_updated_date": "17/07/2000", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pylori-chek" } ] }