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"post_authorisation_procedure_status": "Opinion", "post_authorisation_opinion_status": "Positive", "post_authorisation_opinion_date": "26/03/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "30/05/2020", "first_published_date": "27/03/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/sarclisa" }, { "category": "Human", "name_of_medicine": "Lojuxta", "ema_product_number": "EMEA/H/C/002578", "active_substance": "Lomitapide", "international_non_proprietary_name_common_name": "lomitapide", "therapeutic_area_mesh": "Hypercholesterolemia", "atc_code_human": "C10AX12", "atcvet_code_veterinary": "", "species_veterinary": "", "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", "post_authorisation_procedure_status": "Opinion", "post_authorisation_opinion_status": "Positive", "post_authorisation_opinion_date": "26/03/2026", "withdrawal_of_application_date": "", "marketing_authorisation_date": "31/07/2013", "first_published_date": "27/03/2026", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/lojuxta" }, { "category": "Human", "name_of_medicine": "Scenesse", "ema_product_number": "EMEA/H/C/002548", "active_substance": "afamelanotide", "international_non_proprietary_name_common_name": "afamelanotide", "therapeutic_area_mesh": "Protoporphyria, Erythropoietic", "atc_code_human": "D02BB02", "atcvet_code_veterinary": "", "species_veterinary": "", "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"Clinuvel Europe Limited", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "24/04/2024", "marketing_authorisation_date": "22/12/2014", "first_published_date": "31/05/2024", "last_updated_date": "05/03/2026", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/scenesse" }, { "category": "Veterinary", "name_of_medicine": "Suvaxyn PRRS MLV", "ema_product_number": "EMEA/V/C/004276", "active_substance": "modified live porcine respiratory and reproductive syndrome virus", "international_non_proprietary_name_common_name": "porcine respiratory and reproductive syndrome virus, live", "therapeutic_area_mesh": "", "atc_code_human": "", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", 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"No", "marketing_authorisation_developer_applicant_holder": "Agios Netherlands B.V.", "post_authorisation_procedure_status": "Opinion", "post_authorisation_opinion_status": "Positive", "post_authorisation_opinion_date": "16/10/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "09/11/2022", "first_published_date": "17/10/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/pyrukynd" }, { "category": "Veterinary", "name_of_medicine": "Sileo", "ema_product_number": "EMEA/V/C/003764", "active_substance": "Dexmedetomidine hydrochloride", "international_non_proprietary_name_common_name": "dexmedetomidine", "therapeutic_area_mesh": "", "atc_code_human": "", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", 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"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.", "post_authorisation_procedure_status": "Opinion", "post_authorisation_opinion_status": "Positive", "post_authorisation_opinion_date": "18/09/2025", "withdrawal_of_application_date": "", "marketing_authorisation_date": "10/09/2013", "first_published_date": "30/09/2025", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/remsima" }, { "category": "Human", "name_of_medicine": "Koselugo", "ema_product_number": "EMEA/H/C/005244", "active_substance": "selumetinib sulfate", "international_non_proprietary_name_common_name": "selumetinib", "therapeutic_area_mesh": "Neurofibromatosis 1", "atc_code_human": "L01EE04", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", 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"active_substance": "florbetapir (18F)", "international_non_proprietary_name_common_name": "florbetapir (18F)", "therapeutic_area_mesh": "Radionuclide Imaging", "atc_code_human": "V09AX05", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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.", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "26/02/2025", "marketing_authorisation_date": "14/01/2013", "first_published_date": "28/03/2025", "last_updated_date": "28/05/2025", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/amyvid" }, { "category": "Human", 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"post_authorisation_opinion_date": "", "withdrawal_of_application_date": "17/03/2021", "marketing_authorisation_date": "", "first_published_date": "07/12/2021", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/variation/aivlosin-0" }, { "category": "Human", "name_of_medicine": "Tecentriq", "ema_product_number": "EMEA/H/C/004143", "active_substance": "atezolizumab", "international_non_proprietary_name_common_name": "atezolizumab", "therapeutic_area_mesh": "Carcinoma, Transitional Cell;Carcinoma, Non-Small-Cell Lung;Urologic Neoplasms;Breast Neoplasms;Small Cell Lung Carcinoma", "atc_code_human": "L01XC32", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "23/06/2021", "marketing_authorisation_date": "20/09/2017", "first_published_date": "23/07/2021", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/tecentriq-1" }, { "category": "Human", "name_of_medicine": "Esbriet", "ema_product_number": "EMEA/H/C/002154", "active_substance": "Pirfenidone", "international_non_proprietary_name_common_name": "pirfenidone", "therapeutic_area_mesh": "Idiopathic Pulmonary Fibrosis;Lung Diseases;Respiratory Tract Diseases", "atc_code_human": "L04AX05", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "19/05/2021", "marketing_authorisation_date": "28/02/2011", "first_published_date": "25/06/2021", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/esbriet" }, { "category": "Human", "name_of_medicine": "Brilique", "ema_product_number": "EMEA/H/C/001241", "active_substance": "ticagrelor", "international_non_proprietary_name_common_name": "ticagrelor", "therapeutic_area_mesh": "Peripheral Vascular Diseases;Acute Coronary Syndrome", "atc_code_human": "B01AC24", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "05/03/2021", "marketing_authorisation_date": "03/12/2010", "first_published_date": "26/03/2021", "last_updated_date": "25/05/2021", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/brilique" }, { "category": "Human", "name_of_medicine": "Tecentriq", "ema_product_number": "EMEA/H/C/004143", "active_substance": "atezolizumab", "international_non_proprietary_name_common_name": "atezolizumab", "therapeutic_area_mesh": "Carcinoma, Transitional Cell;Carcinoma, Non-Small-Cell Lung;Urologic Neoplasms;Breast Neoplasms;Small Cell Lung Carcinoma", "atc_code_human": "L01XC32", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "08/01/2021", "marketing_authorisation_date": "20/09/2017", "first_published_date": "01/02/2021", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/tecentriq-0" }, { "category": "Human", "name_of_medicine": "Yervoy", "ema_product_number": "EMEA/H/C/002213", "active_substance": "Ipilimumab", "international_non_proprietary_name_common_name": "ipilimumab", "therapeutic_area_mesh": "Melanoma;Carcinoma, Renal Cell;Carcinoma, Non-Small-Cell Lung;Mesothelioma, Malignant;Colorectal Neoplasms", "atc_code_human": "L01FX04", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "30/01/2020", "marketing_authorisation_date": "13/07/2011", "first_published_date": "28/02/2020", "last_updated_date": "23/04/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/yervoy" }, { "category": "Human", "name_of_medicine": "Opdivo", "ema_product_number": "EMEA/H/C/003985", "active_substance": "nivolumab", "international_non_proprietary_name_common_name": "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", "atc_code_human": "L01FF01", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "30/01/2020", "marketing_authorisation_date": "19/06/2015", "first_published_date": "28/02/2020", "last_updated_date": "23/04/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/opdivo-2" }, { "category": "Human", "name_of_medicine": "Keytruda", "ema_product_number": "EMEA/H/C/003820", "active_substance": "pembrolizumab", "international_non_proprietary_name_common_name": "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", "atc_code_human": "L01FF02", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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.", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "10/12/2019", "marketing_authorisation_date": "17/07/2015", "first_published_date": "31/01/2020", "last_updated_date": "19/03/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/keytruda-0" }, { "category": "Human", "name_of_medicine": "Axumin", "ema_product_number": "EMEA/H/C/004197", "active_substance": "fluciclovine (18F)", "international_non_proprietary_name_common_name": "fluciclovine (18F)", "therapeutic_area_mesh": "Prostatic Neoplasms;Radionuclide Imaging", "atc_code_human": "V09IX12", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "11/02/2020", "marketing_authorisation_date": "21/05/2017", "first_published_date": "28/02/2020", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/axumin" }, { "category": "Human", "name_of_medicine": "Opsumit", "ema_product_number": "EMEA/H/C/002697", "active_substance": "macitentan", "international_non_proprietary_name_common_name": "macitentan", "therapeutic_area_mesh": "Hypertension, Pulmonary", "atc_code_human": "C02KX04", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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.  ", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "08/11/2019", "marketing_authorisation_date": "20/12/2013", "first_published_date": "15/11/2019", "last_updated_date": "17/02/2020", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/opsumit" }, { "category": "Veterinary", "name_of_medicine": "Coliprotec F4/F18", "ema_product_number": "EMEA/V/C/004225", "active_substance": "Live non-pathogenic Escherichia coli O141:K94 (F18ac) and O8:K87 (F4ac)", "international_non_proprietary_name_common_name": "porcine post-weaning diarrhoea vaccine (live)", "therapeutic_area_mesh": "", "atc_code_human": "", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "27/05/2019", "marketing_authorisation_date": "", "first_published_date": "18/09/2019", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/variation/coliprotec-f4-f18" }, { "category": "Human", "name_of_medicine": "Opdivo", "ema_product_number": "EMEA/H/C/003985", "active_substance": "nivolumab", "international_non_proprietary_name_common_name": "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 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"international_non_proprietary_name_common_name": "atezolizumab", "therapeutic_area_mesh": "Carcinoma, Transitional Cell;Carcinoma, Non-Small-Cell Lung;Urologic Neoplasms;Breast Neoplasms;Small Cell Lung Carcinoma", "atc_code_human": "L01XC32", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "22/10/2018", "marketing_authorisation_date": "20/09/2017", "first_published_date": "16/11/2018", "last_updated_date": "", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/tecentriq" }, { "category": "Human", "name_of_medicine": "Sutent", "ema_product_number": "EMEA/H/C/000687", "active_substance": "sunitinib", "international_non_proprietary_name_common_name": "sunitinib", "therapeutic_area_mesh": "Gastrointestinal Stromal Tumors;Carcinoma, Renal Cell;Neuroendocrine Tumors", "atc_code_human": "L01EX01", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "26/06/2018", "marketing_authorisation_date": "19/07/2006", "first_published_date": "27/07/2018", "last_updated_date": "17/08/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/sutent" }, { "category": "Human", "name_of_medicine": "Qtern", "ema_product_number": "EMEA/H/C/004057", "active_substance": "saxagliptin;dapagliflozin propanediol monohydrate", "international_non_proprietary_name_common_name": "saxagliptin;dapagliflozin", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2;Diabetes Mellitus;Nutritional and Metabolic Diseases;Metabolic Diseases;Glucose Metabolism Disorders", "atc_code_human": "A10BD21", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "03/04/2018", "marketing_authorisation_date": "15/07/2016", "first_published_date": "27/04/2018", "last_updated_date": "27/04/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/qtern" }, { "category": "Human", "name_of_medicine": "Aranesp", "ema_product_number": "EMEA/H/C/000332", "active_substance": "darbepoetin alfa", "international_non_proprietary_name_common_name": "darbepoetin alfa", "therapeutic_area_mesh": "Anemia;Cancer;Kidney Failure, Chronic", "atc_code_human": "B03XA02", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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.", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "21/02/2018", "marketing_authorisation_date": "08/06/2001", "first_published_date": "23/03/2018", "last_updated_date": "24/04/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/aranesp" }, { "category": "Human", "name_of_medicine": "Zydelig", "ema_product_number": "EMEA/H/C/003843", "active_substance": "Idelalisib", "international_non_proprietary_name_common_name": "idelalisib", "therapeutic_area_mesh": "Lymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell", "atc_code_human": "L01XX47", "atcvet_code_veterinary": "", "species_veterinary": "", "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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "30/01/2018", "marketing_authorisation_date": "18/09/2014", "first_published_date": "23/02/2018", "last_updated_date": "23/02/2018", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/zydelig" }, { "category": "Human", "name_of_medicine": "Opdivo", "ema_product_number": "EMEA/H/C/003985", "active_substance": "nivolumab", "international_non_proprietary_name_common_name": "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 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"marketing_authorisation_developer_applicant_holder": "Takeda Pharmaceuticals International AG", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "14/02/2014", "marketing_authorisation_date": "11/07/2008", "first_published_date": "21/02/2014", "last_updated_date": "21/02/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/firazyr" }, { "category": "Human", "name_of_medicine": "Prometax", "ema_product_number": "EMEA/H/C/000255", "active_substance": "rivastigmine", "international_non_proprietary_name_common_name": "rivastigmine", "therapeutic_area_mesh": "Alzheimer Disease;Parkinson Disease;Dementia", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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.", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "21/11/2013", "marketing_authorisation_date": "04/12/1998", "first_published_date": "20/12/2013", "last_updated_date": "18/02/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/prometax" }, { "category": "Human", "name_of_medicine": "Exelon", "ema_product_number": "EMEA/H/C/000169", "active_substance": "rivastigmine", "international_non_proprietary_name_common_name": "rivastigmine", "therapeutic_area_mesh": "Dementia;Alzheimer Disease;Parkinson Disease", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "21/11/2013", "marketing_authorisation_date": "11/05/1998", "first_published_date": "20/12/2013", "last_updated_date": "18/02/2014", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/exelon-0" }, { "category": "Human", "name_of_medicine": "Ceprotin", "ema_product_number": "EMEA/H/C/000334", "active_substance": "human protein C", "international_non_proprietary_name_common_name": "human protein C", "therapeutic_area_mesh": "Purpura Fulminans;Protein C Deficiency", "atc_code_human": "B01AD12", "atcvet_code_veterinary": "", 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"atc_code_human": "N02AB03", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "11/07/2013", "marketing_authorisation_date": "04/04/2008", "first_published_date": "26/07/2013", "last_updated_date": "29/08/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/effentora" }, { "category": "Human", "name_of_medicine": "Eviplera", "ema_product_number": "EMEA/H/C/002312", "active_substance": "emtricitabine;rilpivirine hydrochloride;tenofovir disoproxil 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"name_of_medicine": "Tysabri", "ema_product_number": "EMEA/H/C/000603", "active_substance": "natalizumab", "international_non_proprietary_name_common_name": "natalizumab", "therapeutic_area_mesh": "Multiple Sclerosis", "atc_code_human": "L04AG03", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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.", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "14/05/2013", "marketing_authorisation_date": "27/06/2006", "first_published_date": "31/05/2013", "last_updated_date": "31/05/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/tysabri" }, { "category": "Veterinary", "name_of_medicine": "Zolvix", "ema_product_number": "EMEA/V/C/000154", "active_substance": "monepantel", "international_non_proprietary_name_common_name": "monepantel", "therapeutic_area_mesh": "", "atc_code_human": "", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "19/10/2012", "marketing_authorisation_date": "", "first_published_date": "25/01/2013", "last_updated_date": "25/01/2013", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/variation/zolvix" }, { "category": "Human", "name_of_medicine": "Erbitux", "ema_product_number": "EMEA/H/C/000558", "active_substance": "cetuximab", "international_non_proprietary_name_common_name": "cetuximab", "therapeutic_area_mesh": "Head and Neck Neoplasms;Colorectal Neoplasms", "atc_code_human": "L01FE01", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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. ", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "17/09/2012", "marketing_authorisation_date": "29/06/2004", "first_published_date": "12/10/2012", "last_updated_date": "22/11/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/erbitux" }, { "category": "Human", "name_of_medicine": "Velcade", "ema_product_number": "EMEA/H/C/000539", "active_substance": "bortezomib", "international_non_proprietary_name_common_name": "bortezomib", "therapeutic_area_mesh": "Multiple Myeloma", "atc_code_human": "L01XG01", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "02/07/2012", "marketing_authorisation_date": "26/04/2004", "first_published_date": "31/07/2012", "last_updated_date": "30/08/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/velcade" }, { "category": "Human", "name_of_medicine": "Revlimid", "ema_product_number": "EMEA/H/C/000717", "active_substance": "lenalidomide", "international_non_proprietary_name_common_name": "lenalidomide", "therapeutic_area_mesh": "Multiple Myeloma;Lymphoma, Mantle-Cell;Myelodysplastic Syndromes", "atc_code_human": "L04AX04", "atcvet_code_veterinary": "", "species_veterinary": "", "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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "20/06/2012", "marketing_authorisation_date": "14/06/2007", "first_published_date": "06/07/2012", "last_updated_date": "06/07/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/revlimid" }, { "category": "Veterinary", "name_of_medicine": "Draxxin", "ema_product_number": "EMEA/V/C/000077", "active_substance": "tulathromycin", "international_non_proprietary_name_common_name": "tulathromycin", "therapeutic_area_mesh": "", "atc_code_human": "", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "11/05/2012", "marketing_authorisation_date": "", "first_published_date": "04/07/2012", "last_updated_date": "04/07/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/variation/draxxin" }, { "category": "Human", "name_of_medicine": "Prometax", "ema_product_number": "EMEA/H/C/000255", "active_substance": "rivastigmine", "international_non_proprietary_name_common_name": "rivastigmine", "therapeutic_area_mesh": "Alzheimer Disease;Parkinson Disease;Dementia", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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.", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "14/03/2012", "marketing_authorisation_date": "04/12/1998", "first_published_date": "19/04/2012", "last_updated_date": "19/04/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/prometax-0" }, { "category": "Human", "name_of_medicine": "Exelon", "ema_product_number": "EMEA/H/C/000169", "active_substance": "rivastigmine", "international_non_proprietary_name_common_name": "rivastigmine", "therapeutic_area_mesh": "Dementia;Alzheimer Disease;Parkinson Disease", "atc_code_human": "N06DA03", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "14/03/2012", "marketing_authorisation_date": "11/05/1998", "first_published_date": "19/04/2012", "last_updated_date": "19/04/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/exelon" }, { "category": "Human", "name_of_medicine": "Qutenza", "ema_product_number": "EMEA/H/C/000909", "active_substance": "capsaicin", "international_non_proprietary_name_common_name": "capsaicin", "therapeutic_area_mesh": "Neuralgia", "atc_code_human": "N01BX04", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "14/03/2012", "marketing_authorisation_date": "15/05/2009", "first_published_date": "16/04/2012", "last_updated_date": "16/04/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/qutenza" }, { "category": "Human", "name_of_medicine": "Tyverb", "ema_product_number": "EMEA/H/C/000795", "active_substance": "lapatinib", "international_non_proprietary_name_common_name": "lapatinib", "therapeutic_area_mesh": "Breast Neoplasms", "atc_code_human": "L01EH01", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "15/02/2012", "marketing_authorisation_date": "10/06/2008", "first_published_date": "16/03/2012", "last_updated_date": "16/03/2012", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/tyverb" }, { "category": "Human", "name_of_medicine": "Macugen", "ema_product_number": "EMEA/H/C/000620", "active_substance": "pegaptanib", "international_non_proprietary_name_common_name": "pegaptanib", "therapeutic_area_mesh": "Wet Macular Degeneration", "atc_code_human": "S01LA03", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "15/07/2011", "marketing_authorisation_date": "31/01/2006", "first_published_date": "27/07/2011", "last_updated_date": "27/07/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/macugen" }, { "category": "Human", "name_of_medicine": "Zometa", "ema_product_number": "EMEA/H/C/000336", "active_substance": "zoledronic acid;zoledronic acid monohydrate", "international_non_proprietary_name_common_name": "zoledronic acid", "therapeutic_area_mesh": "Cancer;Fractures, Bone", "atc_code_human": "M05BA08", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "14/12/2010", "marketing_authorisation_date": "20/03/2001", "first_published_date": "25/01/2011", "last_updated_date": "01/01/2011", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/zometa-0" }, { "category": "Human", "name_of_medicine": "Intrinsa", "ema_product_number": "EMEA/H/C/000634", "active_substance": "testosterone", "international_non_proprietary_name_common_name": "testosterone", "therapeutic_area_mesh": "Sexual Dysfunctions, Psychological", "atc_code_human": "G03BA03", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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.", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "29/09/2010", "marketing_authorisation_date": "28/07/2006", "first_published_date": "29/09/2010", "last_updated_date": "29/09/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/intrinsa" }, { "category": "Veterinary", "name_of_medicine": "Naxcel", "ema_product_number": "EMEA/V/C/000079", "active_substance": "ceftiofur", "international_non_proprietary_name_common_name": "ceftiofur", "therapeutic_area_mesh": "", "atc_code_human": "", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "04/02/2010", "marketing_authorisation_date": "", "first_published_date": "23/06/2010", "last_updated_date": "23/06/2010", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/variation/naxcel" }, { "category": "Human", "name_of_medicine": "Abilify", "ema_product_number": "EMEA/H/C/000471", "active_substance": "aripiprazole", "international_non_proprietary_name_common_name": "aripiprazole", "therapeutic_area_mesh": "Schizophrenia;Bipolar Disorder", "atc_code_human": "N05AX12", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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.", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "17/11/2009", "marketing_authorisation_date": "04/06/2004", "first_published_date": "19/11/2009", "last_updated_date": "19/11/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/abilify" }, { "category": "Human", "name_of_medicine": "Stalevo", "ema_product_number": "EMEA/H/C/000511", "active_substance": "levodopa;carbidopa;entacapone", "international_non_proprietary_name_common_name": "levodopa;carbidopa;entacapone", "therapeutic_area_mesh": "Parkinson Disease", "atc_code_human": "N04BA03", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "06/03/2009", "marketing_authorisation_date": "17/10/2003", "first_published_date": "10/03/2009", "last_updated_date": "10/03/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/stalevo" }, { "category": "Veterinary", "name_of_medicine": "Zubrin", "ema_product_number": "EMEA/V/C/000057", "active_substance": "tepoxalin", "international_non_proprietary_name_common_name": "tepoxalin", "therapeutic_area_mesh": "", "atc_code_human": "", "atcvet_code_veterinary": "QM01AE92", "species_veterinary": "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": "Intervet International BV", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "03/10/2008", "marketing_authorisation_date": "13/03/2001", "first_published_date": "24/02/2009", "last_updated_date": "24/02/2009", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/variation/zubrin" }, { "category": "Human", "name_of_medicine": "Invega", "ema_product_number": "EMEA/H/C/000746", "active_substance": "paliperidone", "international_non_proprietary_name_common_name": "paliperidone", "therapeutic_area_mesh": "Schizophrenia;Psychotic Disorders", "atc_code_human": "N05AX13", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "15/12/2008", "marketing_authorisation_date": "24/06/2007", "first_published_date": "17/12/2008", "last_updated_date": "17/12/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/invega" }, { "category": "Human", "name_of_medicine": "Viagra", "ema_product_number": "EMEA/H/C/000202", "active_substance": "sildenafil", "international_non_proprietary_name_common_name": "sildenafil", "therapeutic_area_mesh": "Erectile Dysfunction", "atc_code_human": "G04BE03", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "19/11/2008", "marketing_authorisation_date": "13/09/1998", "first_published_date": "20/11/2008", "last_updated_date": "20/11/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/viagra" }, { "category": "Human", "name_of_medicine": "Taxotere", "ema_product_number": "EMEA/H/C/000073", "active_substance": "docetaxel", "international_non_proprietary_name_common_name": "docetaxel", "therapeutic_area_mesh": "Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Stomach Neoplasms;Breast Neoplasms", "atc_code_human": "L01CD02", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "14/11/2008", "marketing_authorisation_date": "27/11/1995", "first_published_date": "17/11/2008", "last_updated_date": "17/11/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/taxotere" }, { "category": "Human", "name_of_medicine": "Docetaxel Zentiva (previously Docetaxel Winthrop)", "ema_product_number": "EMEA/H/C/000808", "active_substance": "docetaxel", "international_non_proprietary_name_common_name": "docetaxel", "therapeutic_area_mesh": "Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Stomach Neoplasms;Breast Neoplasms", "atc_code_human": "L01CD02", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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.", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "14/11/2008", "marketing_authorisation_date": "20/04/2007", "first_published_date": "17/11/2008", "last_updated_date": "17/11/2008", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/docetaxel-zentiva-previously-docetaxel-winthrop" }, { "category": "Human", "name_of_medicine": "Tygacil", "ema_product_number": "EMEA/H/C/000644", "active_substance": "tigecycline", "international_non_proprietary_name_common_name": "tigecycline", "therapeutic_area_mesh": "Bacterial Infections;Skin Diseases, Bacterial;Soft Tissue Infections", "atc_code_human": "J01AA12", "atcvet_code_veterinary": "", 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"name_of_medicine": "Zometa", "ema_product_number": "EMEA/H/C/000336", "active_substance": "zoledronic acid;zoledronic acid monohydrate", "international_non_proprietary_name_common_name": "zoledronic acid", "therapeutic_area_mesh": "Cancer;Fractures, Bone", "atc_code_human": "M05BA08", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "15/11/2007", "marketing_authorisation_date": "20/03/2001", "first_published_date": "20/11/2007", "last_updated_date": "20/11/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/zometa" }, { "category": "Veterinary", "name_of_medicine": "Draxxin", "ema_product_number": "EMEA/V/C/000077", "active_substance": "tulathromycin", "international_non_proprietary_name_common_name": "tulathromycin", "therapeutic_area_mesh": "", "atc_code_human": "", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_therapy": "No", "biosimilar": "No", "conditional_approval": "No", "exceptional_circumstances": "No", "generic": "No", "orphan_medicine": "No", "prime_priority_medicine": "No", "marketing_authorisation_developer_applicant_holder": "", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "17/01/2007", "marketing_authorisation_date": "", "first_published_date": "17/01/2007", "last_updated_date": "17/01/2007", "medicine_url": "https://www.ema.europa.eu/en/medicines/veterinary/variation/draxxin-0" }, { "category": "Human", "name_of_medicine": "Glivec", "ema_product_number": "EMEA/H/C/000406", "active_substance": "imatinib", "international_non_proprietary_name_common_name": "imatinib", "therapeutic_area_mesh": "Precursor Cell Lymphoblastic Leukemia-Lymphoma;Gastrointestinal Stromal Tumors;Dermatofibrosarcoma;Myelodysplastic-Myeloproliferative Diseases;Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Hypereosinophilic Syndrome", "atc_code_human": "L01EA01", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "18/10/2006", "marketing_authorisation_date": "07/11/2001", "first_published_date": "23/10/2006", "last_updated_date": "23/10/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/glivec" }, { "category": "Human", "name_of_medicine": "NovoNorm", "ema_product_number": "EMEA/H/C/000187", "active_substance": "repaglinide", "international_non_proprietary_name_common_name": "repaglinide", "therapeutic_area_mesh": "Diabetes Mellitus, Type 2", "atc_code_human": "A10BX02", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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 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"marketing_authorisation_developer_applicant_holder": "Novo Nordisk A/S", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "12/10/2006", "marketing_authorisation_date": "29/01/2001", "first_published_date": "13/10/2006", "last_updated_date": "13/10/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/prandin" }, { "category": "Human", "name_of_medicine": "DepoCyte", "ema_product_number": "EMEA/H/C/000317", "active_substance": "cytarabine", "international_non_proprietary_name_common_name": "cytarabine", "therapeutic_area_mesh": "Meningeal Neoplasms", "atc_code_human": "L01BC01", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "28/06/2006", "marketing_authorisation_date": "11/07/2001", "first_published_date": "30/06/2006", "last_updated_date": "30/06/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/depocyte" }, { "category": "Human", "name_of_medicine": "NovoSeven", "ema_product_number": "EMEA/H/C/000074", "active_substance": "eptacog alfa (activated)", "international_non_proprietary_name_common_name": "eptacog alfa (activated)", "therapeutic_area_mesh": "Hemophilia B;Thrombasthenia;Factor VII Deficiency;Hemophilia A", "atc_code_human": "B02BD08", "atcvet_code_veterinary": "", "species_veterinary": "", "accelerated_assessment": "No", "additional_monitoring": "No", 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"", "accelerated_assessment": "No", "additional_monitoring": "No", "advanced_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", "post_authorisation_procedure_status": "Application withdrawn", "post_authorisation_opinion_status": "", "post_authorisation_opinion_date": "", "withdrawal_of_application_date": "14/02/2006", "marketing_authorisation_date": "16/05/2002", "first_published_date": "23/02/2006", "last_updated_date": "23/02/2006", "medicine_url": "https://www.ema.europa.eu/en/medicines/human/variation/opatanol" } ] }