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Date Content
29/09/2023 Template or form: Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - human (updated)
29/09/2023 Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Waldenstrom Macroglobulinemia, 22/11/2021, Additional monitoring, 7, Authorised (updated)
29/09/2023 Human medicines European public assessment report (EPAR): Locametz, gozetotide, Radionuclide Imaging, 09/12/2022, 2, Authorised (updated)
29/09/2023 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
29/09/2023 Human medicines European public assessment report (EPAR): Docetaxel Kabi, docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms, 22/05/2012, Generic, 15, Authorised (updated)
29/09/2023 Human medicines European public assessment report (EPAR): Exforge HCT, valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension, 15/10/2009, 24, Authorised (updated)
29/09/2023 Human medicines European public assessment report (EPAR): Lyfnua, Gefapixant, Cough, 15/09/2023, Additional monitoring, Authorised (updated)
29/09/2023 Human medicines European public assessment report (EPAR): SomaKit TOC, edotreotide, Neuroendocrine Tumors; Radionuclide Imaging, 08/12/2016, Orphan, 15, Authorised (updated)
29/09/2023 Pre-authorisation guidance (updated)
29/09/2023 Human medicines European public assessment report (EPAR): Adakveo, Crizanlizumab, Anemia, Sickle Cell, 28/10/2020, Additional monitoring, Conditional approval, 6, Withdrawn (updated)
29/09/2023 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023 (updated)
29/09/2023 Referral: Hydroxyprogesterone-containing medicinal products , hydroxyprogesterone, Lentogest,Progesterone Retard Pharlon,Proluton Depot, Article 31 referrals, Procedure started, 29/09/2023 (updated)
29/09/2023 COMP: Agendas, minutes and meeting reports (updated)
29/09/2023 Template or form: Template: Declaration for the risk management plan (RMP) publication (updated)
29/09/2023 Template or form: Template for submission of comments for the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet) (updated)
29/09/2023 Other: Call for comments on the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet) (updated)
29/09/2023 Other: Combined VeDDRA list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products (updated)
29/09/2023 Risk management plans (updated)
29/09/2023 Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use , European Medicines Agency and online, from 26/06/2023 to 27/06/2023 (updated)
29/09/2023 Regulatory and procedural guideline: Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms (updated)
29/09/2023 Regulatory and procedural guideline: Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products (updated)
29/09/2023 Periodic safety update single assessment: Mefloquine : List of nationally authorised medicinal products - PSUSA/00001955/202302
29/09/2023 Periodic safety update single assessment: Saccharomyces boulardii : List of nationally authorised medicinal products - PSUSA/00009284/202302
29/09/2023 Periodic safety update single assessment: Haemophilus type b conjugate vaccines : List of nationally authorised medicinal products - PSUSA/00001584/202302
29/09/2023 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
29/09/2023 Periodic safety update single assessment: Ipratropium / salbutamol : List of nationally authorised medicinal products - PSUSA/00001781/202301
29/09/2023 Periodic safety update single assessment: Ipratropium : List of nationally authorised medicinal products - PSUSA/00001780/202301
29/09/2023 Periodic safety update single assessment: Sodium citrate (extracorporeal use) : List of nationally authorised medicinal products - PSUSA/00010986/202301
29/09/2023 Periodic safety update single assessment: Influenza vaccine (split virion, inactivated) (non centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00010298/202303
29/09/2023 Periodic safety update single assessment: Haemophilus type b and meningococcal group C conjugate vaccine : List of nationally authorised medicinal products - PSUSA/00001583/202302
29/09/2023 Periodic safety update single assessment: Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202303
29/09/2023 Referral: Pseudoephedrine-containing medicinal products , pseudoephedrine, Article 31 referrals, Under evaluation, 29/09/2023 (updated)
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) vector expressing the full-length LAMB3 cDNA (Hologene 5), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0375/2022
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ibrexafungerp citrate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0370/2022
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Aspaveli, Pegcetacoplan, W: decision granting a waiver in all age groups for all conditions or indications, P/0403/2022
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Clazakizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0393/2022
28/09/2023 Periodic safety update single assessment: Fenoterol / ipratropium : List of nationally authorised medicinal products - PSUSA/00001367/202302
28/09/2023 Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), 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, COVID-19 virus infection, 06/01/2021, Patient safety, Additional monitoring, 40, Authorised (updated)
28/09/2023 Human medicines European public assessment report (EPAR): Hepcludex, Bulevirtide acetate, Hepatitis D, Chronic, 31/07/2020, Orphan, Additional monitoring, 11, Authorised (updated)
28/09/2023 Human medicines European public assessment report (EPAR): Rivaroxaban Accord, rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism, 16/11/2020, Generic, 5, Authorised (updated)
28/09/2023 Human medicines European public assessment report (EPAR): Comirnaty, 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, COVID-19 virus infection, 21/12/2020, Patient safety, Additional monitoring, 44, Authorised (updated)
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Momelotinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0157/2015 (updated)
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Momelotinib, W: decision granting a waiver in all age groups for all conditions or indications, P/0249/2019 (updated)
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Marstacimab, PM: decision on the application for modification of an agreed PIP, P/0443/2022 (updated)
28/09/2023 Human medicines European public assessment report (EPAR): Imatinib Teva, imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma, 07/01/2013, Generic, 19, Authorised (updated)
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain, PM: decision on the application for modification of an agreed PIP, P/0442/2022 (updated)
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Fetcroja, Cefiderocol, PM: decision on the application for modification of an agreed PIP, P/0441/2022 (updated)
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Insulin human (NTRA-2112), PM: decision on the application for modification of an agreed PIP, P/0458/2022 (updated)
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Voxzogo, Vosoritide, PM: decision on the application for modification of an agreed PIP, P/0453/2022 (updated)
28/09/2023 Human medicines European public assessment report (EPAR): Ziagen, abacavir, HIV Infections, 08/07/1999, 47, Authorised (updated)
28/09/2023 Other: Appendix 1: Acceptable intakes established for N-nitrosamines (updated)
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Finasteride,tadalafil, W: decision granting a waiver in all age groups for all conditions or indications, P/0461/2022
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin (calcium),Telmisartan, W: decision granting a waiver in all age groups for all conditions or indications, P/0460/2022
28/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Derivative of (3S,3'S,3a'S,10a'S)-3'-phenyl-3',3a',10',10a'-tetrahydro-1'H-spiro[indoline-3,2'- pyrrolo[2',3':4,5]pyrrolo[1,2-b]indazol]-2-one, W: decision granting a waiver in all age groups for all conditions or indications, P/0459/2022
28/09/2023 Other: Responses to list of issues - GFR slope as a Surrogate Endpoint in RCT for CKD (updated)
28/09/2023 News and press releases: EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep (updated)
28/09/2023 Human medicines European public assessment report (EPAR): Tyruko, natalizumab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, 22/09/2023, Additional monitoring, Biosimilar, Authorised (updated)
28/09/2023 Conversations on Cancer presents “Living with Metastatic Breast Cancer” , Online, 15:30 - 17:00 Amsterdam time (CEST), from 19/10/2023 to 19/10/2023
27/09/2023 Other: Registration guide - Union Product Database (UPD) for veterinary medicinal products (updated)
27/09/2023 EMA Veterinary Awareness Day , Online, 09:00-15:30 Amsterdam time (CEST), from 12/09/2023 to 13/09/2023 (updated)
27/09/2023 Human medicines European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva, SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection, 24/06/2022, Additional monitoring, 6, Authorised (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Zavicefta, avibactam sodium, ceftazidime pentahydrate, Pneumonia, Bacterial; Soft Tissue Infections; Pneumonia; Urinary Tract Infections; Gram-Negative Bacterial Infections, 23/06/2016, Additional monitoring, 15, Authorised (updated)
27/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Lidocaine (hydrochloride monohydrate), W: decision granting a waiver in all age groups for all conditions or indications, P/0419/2022
27/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): 3-(1,3-benzodioxol-5-yl)-5-(3-bromophenyl)-1H-pyrazole, W: decision granting a waiver in all age groups for all conditions or indications, P/0420/2022
27/09/2023 Human medicines European public assessment report (EPAR): Kirsty (previously Kixelle), insulin aspart, Diabetes Mellitus, 05/02/2021, Additional monitoring, Biosimilar, 3, Authorised (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Synjardy, empagliflozin, metformin, Diabetes Mellitus, Type 2, 27/05/2015, 26, Authorised (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Glyxambi, empagliflozin, linagliptin, Diabetes Mellitus, Type 2, 11/11/2016, 16, Authorised (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, 14/01/2019, Additional monitoring, 11, Authorised (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan, Acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction, 09/01/2020, Generic, 5, Authorised (updated)
27/09/2023 Meeting of the CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients and Consumers Working Party (PCWP) , Online, from 20/07/2023 to 20/07/2023
27/09/2023 Human medicines European public assessment report (EPAR): Eporatio, epoetin theta, Kidney Failure, Chronic; Anemia; Cancer, 29/10/2009, 13, Authorised (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Biopoin, epoetin theta, Kidney Failure, Chronic; Anemia; Cancer, 23/10/2009, 15, Authorised (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Dafiro HCT, valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension, 03/11/2009, 25, Authorised (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine, valsartan, hydrochlorothiazide, Hypertension, 03/11/2009, 24, Authorised (updated)
27/09/2023 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Trepulmix, Treprostinil sodium, Hypertension, Pulmonary, 03/04/2020, Orphan, 4, Authorised (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Sovaldi, Sofosbuvir, Hepatitis C, Chronic, 16/01/2014, Accelerated assessment, 28, Authorised (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Vosevi, Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic, 26/07/2017, 16, Authorised (updated)
27/09/2023 SPOR and xEVMPD Stakeholder Engagement Webinars : Organisation Management Service (OMS) , Online, from 04/10/2023 to 04/10/2023 (updated)
27/09/2023 SPOR and xEVMPD Stakeholder Engagement Webinars : Referentials Management Service (RMS) , Online, from 03/10/2023 to 03/10/2023 (updated)
27/09/2023 SPOR and xEVMPD Stakeholder Engagement Webinars : SPOR Data Governance , Online, from 02/10/2023 to 02/10/2023 (updated)
27/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tofacitinib, PM: decision on the application for modification of an agreed PIP, P/0055/2017 (updated)
27/09/2023 SPOR and xEVMPD Stakeholder Engagement Webinars : Product Management Service (XEVMPD) , Online, from 06/10/2023 to 06/10/2023 (updated)
27/09/2023 SPOR and xEVMPD Stakeholder Engagement Webinars : EMA Account Management , Online, from 11/10/2023 to 11/10/2023 (updated)
27/09/2023 SPOR and xEVMPD Stakeholder Engagement Webinars : Substance, product, organisation and referential (SPOR) application programming interface (API) - SPOR API , Online, from 12/10/2023 to 12/10/2023 (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Harvoni, ledipasvir, Sofosbuvir, Hepatitis C, Chronic, 17/11/2014, Accelerated assessment, 28, Authorised (updated)
27/09/2023 Human medicines European public assessment report (EPAR): Epclusa, Sofosbuvir, velpatasvir, Hepatitis C, Chronic, 06/07/2016, Accelerated assessment, 22, Authorised (updated)
26/09/2023 Academia Info Day , European Medicines Agency, Amsterdam, 09:30 - 13:30 (CET), from 10/11/2023 to 10/11/2023
26/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir, PM: decision on the application for modification of an agreed PIP, P/0180/2022 (updated)
26/09/2023 CHMP opinions on consultation procedures (updated)
26/09/2023 Human medicines European public assessment report (EPAR): Ultomiris, ravulizumab, Hemoglobinuria, Paroxysmal, 02/07/2019, Additional monitoring, 13, Authorised (updated)
26/09/2023 List of medicines under additional monitoring (updated)
26/09/2023 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
26/09/2023 Quarterly system demo - Q3 2023 , Online, 09:00 - 13:00 Amsterdam time (CEST), from 21/09/2023 to 21/09/2023 (updated)
26/09/2023 Other: Orientation guide for patient representatives and healthcare professionals - EMA building (updated)
26/09/2023 How to find us (updated)
26/09/2023 Other: Orientation guide for delegates - EMA building (updated)
26/09/2023 Human medicines European public assessment report (EPAR): Abrysvo, Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein, Respiratory Syncytial Virus Infections, 23/08/2023, Accelerated assessment, Additional monitoring, Authorised (updated)
26/09/2023 Human medicines European public assessment report (EPAR): Myfenax, mycophenolate mofetil, Graft Rejection, 21/02/2008, Generic, 27, Authorised (updated)
26/09/2023 Human medicines European public assessment report (EPAR): Brimica Genuair, formoterol fumarate dihydrate, aclidinium bromide, Pulmonary Disease, Chronic Obstructive, 19/11/2014, Additional monitoring, 14, Authorised (updated)
26/09/2023 Other: MedDRA Important medical event terms list - version 26.1 (updated)
26/09/2023 Vaccine Monitoring Platform (updated)
26/09/2023 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
25/09/2023 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting , Online, from 19/09/2023 to 20/09/2023 (updated)
25/09/2023 Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 18/12/2018, 6, Authorised (updated)
25/09/2023 PRAC: Agendas, minutes and highlights (updated)
25/09/2023 Human medicines European public assessment report (EPAR): Abiraterone Accord, abiraterone acetate, Prostatic Neoplasms, 26/04/2021, Generic, 1, Authorised (updated)
25/09/2023 Human medicines European public assessment report (EPAR): Hyftor, Sirolimus, Angiofibroma; Tuberous Sclerosis, 15/05/2023, Orphan, 2, Authorised (updated)
25/09/2023 Human medicines European public assessment report (EPAR): Invirase, saquinavir, HIV Infections, 03/10/1996, 50, Withdrawn (updated)
25/09/2023 Human medicines European public assessment report (EPAR): ellaOne, ulipristal, Contraception, Postcoital, 15/05/2009, 30, Authorised (updated)
25/09/2023 Medicine QA: Questions and answers on the assessment of the deficiencies in the safety reporting system at Roche Registration Ltd (updated)
25/09/2023 Human medicines European public assessment report (EPAR): Olanzapine Teva, olanzapine, Schizophrenia; Bipolar Disorder, 12/12/2007, Generic, 30, Authorised (updated)
25/09/2023 Human medicines European public assessment report (EPAR): Amglidia, glibenclamide, Diabetes Mellitus, 24/05/2018, Orphan, 7, Authorised (updated)
25/09/2023 Human medicines European public assessment report (EPAR): Orphacol, cholic acid, Digestive System Diseases; Metabolism, Inborn Errors, 12/09/2013, 25/05/2012, Additional monitoring, Exceptional circumstances, 13, Authorised (updated)
25/09/2023 Orphan designation: cholic acid for the: Treatment of inborn errors in primary bile acid synthesis, 18/12/2002, Positive (updated)
25/09/2023 Other: List of signals discussed at PRAC since September 2012 (updated)
25/09/2023 Human medicines European public assessment report (EPAR): Bridion, sugammadex, Neuromuscular Blockade, 25/07/2008, 22, Authorised (updated)
25/09/2023 Human medicines European public assessment report (EPAR): Rivastigmine Sandoz, rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease, 10/12/2009, 14, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Imbruvica, Ibrutinib, Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell, 21/10/2014, 31, Authorised (updated)
22/09/2023 Good clinical practice (GCP) inspection procedures (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Lenalidomide Accord, lenalidomide, Multiple Myeloma, 20/09/2018, Generic, 11, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Tezspire, tezepelumab, Asthma, 19/09/2022, Additional monitoring, 7, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Rybrevant, amivantamab, Carcinoma, Non-Small-Cell Lung, 09/12/2021, Additional monitoring, Conditional approval, 3, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, 22/11/2018, Additional monitoring, 9, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Enhertu, trastuzumab deruxtecan, Breast Neoplasms, 18/01/2021, Additional monitoring, Conditional approval, 12, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Vantobra (previously Tobramycin PARI), Tobramycin, Respiratory Tract Infections; Cystic Fibrosis, 18/02/2019, 5, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): LysaKare, L-arginine hydrochloride, L-lysine hydrochloride, Radiation Injuries, 25/07/2019, 4, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Vyndaqel, tafamidis, Amyloidosis, 16/11/2011, Orphan, Additional monitoring, Exceptional circumstances, 27, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Opfolda, miglustat, Glycogen Storage Disease Type II, 26/06/2023, 1, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Scemblix, asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 25/08/2022, Orphan, Additional monitoring, 3, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Levetiracetam Sun, levetiracetam, Epilepsy, 14/12/2011, Generic, 19, Authorised (updated)
22/09/2023 Union Product Database – Product grouping and 3rd country product names Webinar for UPD Industry users , Online, 14:00 - 15:00 Amsterdam time (CEST), from 18/09/2023 to 18/09/2023 (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Vaxneuvance, pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections, 13/12/2021, Additional monitoring, 5, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Imjudo, Tremelimumab, Carcinoma, Hepatocellular, 20/02/2023, Additional monitoring, 2, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors, 26/09/2017, Orphan, 10, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly), tadalafil, Hypertension, Pulmonary, 01/10/2008, 17, Authorised (updated)
22/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin,perindopril, W: decision granting a waiver in all age groups for all conditions or indications, P/0376/2022
22/09/2023 Orphan designation: Belzupacap sarotalocan for the: Treatment of uveal melanoma, 13/04/2022 (updated)
22/09/2023 Orphan designation: (S)-1-(5-((2,3-dihydro-[1,4]dioxino[2,3-b]pyridin-7-yl)sulfonyl)-3,4,5,6-tetrahydropyrrolo[3,4-c]pyrrol-2(1H)-yl)-3-hydroxy-2-phenylpropan-1-one for the: Treatment of sickle cell disease, 19/10/2020, Positive (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Procysbi, mercaptamine bitartrate, Cystinosis, 05/09/2013, 16, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Retsevmo, Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms, 11/02/2021, Additional monitoring, Conditional approval, 8, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Prolia, denosumab, Bone Resorption; Osteoporosis, Postmenopausal, 26/05/2010, 27, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Fortacin, lidocaine, prilocaine, Sexual Dysfunction, Physiological, 15/11/2013, 12, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Vitrakvi, larotrectinib sulfate, Abdominal Neoplasms, 19/09/2019, Additional monitoring, Conditional approval, 10, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Semglee, insulin glargine, Diabetes Mellitus, 23/03/2018, Biosimilar, 9, Authorised (updated)
22/09/2023 Human medicines European public assessment report (EPAR): Tenkasi (previously Orbactiv), oritavancin (diphosphate), Soft Tissue Infections; Skin Diseases, Bacterial, 19/03/2015, 14, Authorised (updated)
22/09/2023 Procurement (updated)
22/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy- 10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,- 14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]- oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyldimethyl-phosphinate (MK-8669, or AP23573), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/2/2010 (updated)
21/09/2023 PRIME: priority medicines (updated)
21/09/2023 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 11-14 September 2023
21/09/2023 Other: List of medicines currently in PRIME scheme (updated)
21/09/2023 Agenda: Agenda of the HMPC meeting 18-20 September 2023
21/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Etrasimod L-arginine, PM: decision on the application for modification of an agreed PIP, P/0409/2022 (updated)
21/09/2023 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting , Amsterdam, from 28/06/2023 to 28/06/2023 (updated)
21/09/2023 10th anniversary of European Medicines Agency (EMA) Healthcare Professionals' (HCPWP) Working Party meeting , Amsterdam, from 27/06/2023 to 27/06/2023 (updated)
21/09/2023 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) Working Party meeting , Amsterdam, from 27/06/2023 to 27/06/2023 (updated)
21/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): sotatercept, PM: decision on the application for modification of an agreed PIP, P/0414/2022 (updated)
21/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Adrenaline (epinephrine), PM: decision on the application for modification of an agreed PIP, P/0404/2022 (updated)
21/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Monalizumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0405/2022
21/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Plasma kallikrein inhibitor, PM: decision on the application for modification of an agreed PIP, P/0379/2022 (updated)
21/09/2023 Human medicines European public assessment report (EPAR): Tadalafil Lilly, tadalafil, Erectile Dysfunction, 22/03/2017, 6, Authorised (updated)
21/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Corticotropin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0384/2022
21/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Etranacogene dezaparvovec, PM: decision on the application for modification of an agreed PIP, P/0380/2022 (updated)
21/09/2023 Human medicines European public assessment report (EPAR): Lynparza, Olaparib, Ovarian Neoplasms, 16/12/2014, 23, Authorised (updated)
21/09/2023 Human medicines European public assessment report (EPAR): Fasenra, Benralizumab, Asthma, 08/01/2018, 12, Authorised (updated)
21/09/2023 Human medicines European public assessment report (EPAR): Talvey, talquetamab, Multiple Myeloma, 21/08/2023, Orphan, Additional monitoring, Conditional approval, Authorised (updated)
21/09/2023 Human medicines European public assessment report (EPAR): Infanrix Hexa, 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, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria, 23/10/2000, 47, Authorised (updated)
21/09/2023 Orphan designation: Talquetamab for the: Treatment of multiple myeloma, 20/08/2021, Positive (updated)
21/09/2023 Periodic safety update reports (PSURs) (updated)
21/09/2023 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
21/09/2023 Human medicines European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), ChAdOx1-SARS-COV-2, COVID-19 virus infection, 29/01/2021, Additional monitoring, 30, Authorised (updated)
21/09/2023 Industry annual bilateral meetings
21/09/2023 Industry Standing Group meetings
21/09/2023 Industry stakeholder platform meetings
21/09/2023 Industry Standing Group
21/09/2023 Pharmaceutical industry (updated)
21/09/2023 Human medicines European public assessment report (EPAR): Paxlovid, nirmatrelvir, ritonavir, COVID-19 virus infection, 28/01/2022, 13, Authorised (updated)
21/09/2023 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 15:00 - 17:00 Amsterdam time (CEST), from 22/09/2023 to 22/09/2023 (updated)
21/09/2023 Agenda: Agenda - Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (22 September 2023)
21/09/2023 Human medicines European public assessment report (EPAR): Olumiant, Baricitinib, Arthritis, Rheumatoid, 13/02/2017, Patient safety, 16, Authorised (updated)
21/09/2023 Human medicines European public assessment report (EPAR): Ristaben, sitagliptin, Diabetes Mellitus, Type 2, 15/03/2010, 27, Authorised (updated)
20/09/2023 Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms; Breast Neoplasms, 09/02/2018, Biosimilar, 20, Authorised (updated)
20/09/2023 Shaping a European innovation ecosystem: EU-Innovation network multi-stakeholder meeting , Hybrid (Madrid and online), from 26/09/2023 to 26/09/2023 (updated)
20/09/2023 Human medicines European public assessment report (EPAR): Apretude, Cabotegravir, HIV Infections, 15/09/2023, Authorised (updated)
20/09/2023 Human medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Radionuclide Imaging; Alzheimer Disease, 22/08/2014, 16, Authorised (updated)
20/09/2023 Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis, 26/07/2018, Biosimilar, 14, Authorised (updated)
20/09/2023 Human medicines European public assessment report (EPAR): Hyrimoz, adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous, 26/07/2018, Biosimilar, 13, Authorised (updated)
20/09/2023 Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Multiple Sclerosis, 30/01/2014, 28, Authorised (updated)
20/09/2023 Direct healthcare professional communication (DHPC): Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) suspension for injection in pre-filled syringe: Important information regarding the potential for breakage of Vaxneuvance pre-filled syringes, Active substance: Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed), DHPC type: Quality defect, Last updated: 20/09/2023 (updated)
20/09/2023 Human medicines European public assessment report (EPAR): Omnitrope, somatropin, Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary, 12/04/2006, Biosimilar, 22, Authorised (updated)
20/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Rozanolixizumab, PM: decision on the application for modification of an agreed PIP, P/0410/2022 (updated)
20/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Vumerity, Diroximel fumarate (BIIB098), PM: decision on the application for modification of an agreed PIP, P/0413/2022 (updated)
20/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Zoliflodacin, PM: decision on the application for modification of an agreed PIP, P/0381/2022 (updated)
20/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Xofluza, Baloxavir marboxil, PM: decision on the application for modification of an agreed PIP, P/0383/2022 (updated)
20/09/2023 Report: Medicinal products for human use: monthly figures - August 2023
20/09/2023 Periodic safety update single assessment: Calcium chloride dihydrate/magnesium chloride hexahydrate/malic acid/sodium acetate trihydrate/sodium chloride....potassium chloride : List of nationally authorised medicinal products - PSUSA/00010622/202301
20/09/2023 Human medicines European public assessment report (EPAR): Cialis, tadalafil, Erectile Dysfunction, 12/11/2002, 31, Authorised (updated)
19/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Bismuth (subcitrate),Metronidazole (benzoate),Tetracycline (hydrochloride), W: decision granting a waiver in all age groups for all conditions or indications, P/0371/2022
19/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab, PM: decision on the application for modification of an agreed PIP, P/0395/2022 (updated)
19/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Veyvondi, vonicog alfa, PM: decision on the application for modification of an agreed PIP, P/0363/2022 (updated)
19/09/2023 Human medicines European public assessment report (EPAR): Strimvelis, 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, Severe Combined Immunodeficiency, 26/05/2016, Orphan, Additional monitoring, 9, Authorised (updated)
19/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, Baricitinib, PM: decision on the application for modification of an agreed PIP, P/0364/2022 (updated)
19/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Vocabria, Cabotegravir, PM: decision on the application for modification of an agreed PIP, P/0396/2022 (updated)
19/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, Inotuzumab ozogamicin, PM: decision on the application for modification of an agreed PIP, P/0398/2022 (updated)
19/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tremfya, Guselkumab, PM: decision on the application for modification of an agreed PIP, P/0399/2022 (updated)
19/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Roxadustat, PM: decision on the application for modification of an agreed PIP, P/0400/2022 (updated)
19/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Descovy, emtricitabine,tenofovir alafenamide, PM: decision on the application for modification of an agreed PIP, P/0402/2022 (updated)
19/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Epcoritamab, PM: decision on the application for modification of an agreed PIP, P/0415/2022 (updated)
19/09/2023 Plasma master file certificates (updated)
19/09/2023 Orphan designation: Celecoxib, Ciprofloxacin for the: Treatment of amyotrophic lateral sclerosis, 06/01/2021, Positive (updated)
19/09/2023 Human medicines European public assessment report (EPAR): Revlimid, lenalidomide, Multiple Myeloma; Lymphoma, Mantle-Cell; Myelodysplastic Syndromes, 14/06/2007, Additional monitoring, 50, Authorised (updated)
19/09/2023 Human medicines European public assessment report (EPAR): Steglujan, ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate, Diabetes Mellitus, Type 2, 23/03/2018, 11, Authorised (updated)
19/09/2023 Committee for Advanced Therapies (CAT): 12-14 July 2023 , European Medicines Agency, Amsterdam, the Netherlands, from 12/07/2023 to 14/07/2023 (updated)
19/09/2023 Human medicines European public assessment report (EPAR): Tesavel, sitagliptin, Diabetes Mellitus, Type 2, 10/01/2008, 28, Authorised (updated)
19/09/2023 Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, von Willebrand Diseases, 31/08/2018, Additional monitoring, 8, Authorised (updated)
19/09/2023 Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Diabetes Mellitus, Type 2, 21/03/2007, 38, Authorised (updated)
19/09/2023 Committee for Orphan Medicinal Products (COMP): 11-13 July 2023 , European Medicines Agency, Amsterdam, the Netherlands, from 11/07/2023 to 13/07/2023 (updated)
19/09/2023 ACT EU multi-stakeholder platform kick-off workshop , European Medicines Agency and online, day 1: 13:00 - 18:30, day 2: 08:30 - 13:30, Amsterdam time (CEST), from 22/06/2023 to 23/06/2023 (updated)
18/09/2023 Human medicines European public assessment report (EPAR): Apealea, paclitaxel, Ovarian Neoplasms, 20/11/2018, 7, Authorised (updated)
18/09/2023 Human medicines European public assessment report (EPAR): Januvia, sitagliptin, Diabetes Mellitus, Type 2, 20/03/2007, 32, Authorised (updated)
18/09/2023 Human medicines European public assessment report (EPAR): Litfulo, ritlecitinib tosilate, Alopecia Areata, 15/09/2023, Additional monitoring, Authorised (updated)
18/09/2023 Questions and answers for biological medicinal products
18/09/2023 Joint EMA-ECDC press briefing on current state of respiratory diseases and treatments in the EU/EEA , Online, 14:30 – 15:00 Amsterdam time (CEST), from 21/09/2023 to 21/09/2023
18/09/2023 Human medicines European public assessment report (EPAR): Lumeblue (previously known as Methylthioninium chloride Cosmo), methylthioninium chloride, Colorectal Neoplasms; Colonoscopy, 19/08/2020, 3, Authorised (updated)
18/09/2023 Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Epilepsy; Anxiety Disorders; Neuralgia, 05/07/2004, 61, Authorised (updated)
18/09/2023 Union Product Database: release notes (updated)
18/09/2023 Other: Release notes - production release version 1.6.34 September 2023 - Veterinary Medicinal Products Regulation: Union Product Database
18/09/2023 Sixth Industry Standing Group (ISG) meeting , from 21/09/2023 to 21/09/2023
18/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Evkeeza, Evinacumab, PM: decision on the application for modification of an agreed PIP, P/0394/2022 (updated)
18/09/2023 Human medicines European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau), Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors, 10/04/2017, Orphan, Additional monitoring, Exceptional circumstances, 6, Authorised (updated)
18/09/2023 Human medicines European public assessment report (EPAR): Jinarc, Tolvaptan, Polycystic Kidney, Autosomal Dominant, 27/05/2015, Additional monitoring, 20, Authorised (updated)
18/09/2023 Human medicines European public assessment report (EPAR): Viagra, sildenafil, Erectile Dysfunction, 13/09/1998, 45, Authorised (updated)
18/09/2023 Human medicines European public assessment report (EPAR): Zarzio, filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer, 06/02/2009, Biosimilar, 23, Authorised (updated)
18/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tremelimumab, PM: decision on the application for modification of an agreed PIP, P/0367/2022 (updated)
18/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Imfinzi, durvalumab, PM: decision on the application for modification of an agreed PIP, P/0366/2022 (updated)
18/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine hydrochloride, PM: decision on the application for modification of an agreed PIP, P/0390/2022 (updated)
18/09/2023 Human medicines European public assessment report (EPAR): GHRYVELIN (previously Macimorelin Aeterna Zentaris), macimorelin acetate, Diagnostic Techniques, Endocrine, 11/01/2019, Additional monitoring, 3, Authorised (updated)
18/09/2023 Academia (updated)
18/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Piqray, Alpelisib, PM: decision on the application for modification of an agreed PIP, P/0412/2022 (updated)
18/09/2023 Orphan designation: 3-{[2,3,5,6-tetrafluoro-3'-(trifluoromethoxy)biphenyl-4-yl]carbamoyl}thiophene-2-carboxylic acid for the: Treatment of non-infectious uveitis, 19/06/2015, Positive (updated)
18/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Anti-CD7 mAb conjugated to ricin toxin A chain,Anti-CD3 mAb conjugated to ricin toxin A chain, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0369/2022 (updated)
18/09/2023 Human medicines European public assessment report (EPAR): Idelvion, albutrepenonacog alfa, Hemophilia B, 11/05/2016, Orphan, 12, Authorised (updated)
18/09/2023 Human medicines European public assessment report (EPAR): Rixathon, rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus, 15/06/2017, Biosimilar, 11, Authorised (updated)
18/09/2023 Human medicines European public assessment report (EPAR): Riximyo, rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis, 15/06/2017, Biosimilar, 13, Authorised (updated)
18/09/2023 Other: Timetable: Annual renewal application of conditional marketing authorisation (updated)
18/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Dovato, lamivudine,dolutegravir, PM: decision on the application for modification of an agreed PIP, P/0391/2022 (updated)
18/09/2023 Human medicines European public assessment report (EPAR): Ranivisio, ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications, 25/08/2022, Additional monitoring, Biosimilar, 3, Authorised (updated)
18/09/2023 Other: Timetable: Annual reassessment (updated)
18/09/2023 Opinion/decision on a Paediatric investigation plan (PIP): Copanlisib, PM: decision on the application for modification of an agreed PIP, P/0385/2022 (updated)
18/09/2023 Other: Timetable: Marketing authorisation renewal application (updated)