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07/02/2023 Human medicines European public assessment report (EPAR): Fintepla, Fenfluramine hydrochloride, Epilepsies, Myoclonic, 18/12/2020, Orphan, Additional monitoring, 4, Authorised (updated)
07/02/2023 Fourth Nitrosamine Implementation Oversight Group (NIOG) meeting , from 30/11/2022 to 30/11/2022 (updated)
07/02/2023 Human medicines European public assessment report (EPAR): Lupkynis, Voclosporin, Lupus Nephritis, 15/09/2022, Additional monitoring, 1, Authorised (updated)
07/02/2023 Work programme: COMP work plan 2023
07/02/2023 Committee for Orphan Medicinal Products (COMP) (updated)
07/02/2023 Scientific publications (updated)
07/02/2023 Vaccine Monitoring Platform
07/02/2023 Human medicines European public assessment report (EPAR): Imcivree, Setmelanotide, Obesity, 16/07/2021, Orphan, Additional monitoring, 6, Authorised (updated)
07/02/2023 Withdrawn application: Imbarkyd, bardoxolone methyl, Date of withdrawal: 09/11/2022, Initial authorisation (updated)
07/02/2023 Human medicines European public assessment report (EPAR): Epidyolex, Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic, 19/09/2019, Orphan, 12, Authorised (updated)
07/02/2023 Periodic safety update single assessment: Betaxolol : List of nationally authorised medicinal products - PSUSA/00000401/202205
07/02/2023 Periodic safety update single assessment: Levonorgestrel (for emergency contraception only) : List of nationally authorised medicinal products - PSUSA/00010827/202205
07/02/2023 Human medicines European public assessment report (EPAR): Kisqali, ribociclib succinate, Breast Neoplasms, 22/08/2017, 13, Authorised (updated)
07/02/2023 Orphan designation: Berzosertib for the: Treatment of small cell lung cancer, 18/07/2022, Withdrawn (updated)
07/02/2023 Orphan designation: Rebastinib for the: Treatment of ovarian cancer, 12/11/2021, Positive (updated)
07/02/2023 European Medicines Agency veterinary medicines info day 2023 , Online, from 16/02/2023 to 17/02/2023 (updated)
07/02/2023 Website outages and upgrades (updated)
07/02/2023 Other: Clinical Trials Information System - Risk mitigation plan
07/02/2023 Other: Recommended due dates for submission of annual statements for centrally and non-centrally authorised products (CAPs and non-CAPs) to end 2023
06/02/2023 HMA/EMA multi-stakeholder workshop on shortages , European Medicines Agency, Amsterdam, The Netherlands, from 01/03/2023 to 02/03/2023 (updated)
06/02/2023 Union Product Database (updated)
06/02/2023 Human medicines European public assessment report (EPAR): Dupixent, dupilumab, Dermatitis, Atopic, 26/09/2017, 21, Authorised (updated)
06/02/2023 EPAR - Assessment report - Variation: Dupixent-H-C-4390-P46-007 : EPAR - Assessment Report
06/02/2023 PRAC: Agendas, minutes and highlights (updated)
06/02/2023 News and press releases: EMA update on shortages of antibiotics in the EU (updated)
06/02/2023 Supply shortage: Amoxicillin and amoxicillin/clavulanic acid supply shortage (updated)
06/02/2023 Information session on the pilot for expert panels’ scientific advice to manufacturers of high-risk medical devices , Online, 14:00 - 15:30 Amsterdam time (CET), from 25/01/2023 to 25/01/2023 (updated)
06/02/2023 Orphan designation: Dodecyl creatine ester, dodecyl creatine ester hydrochloride for the: Treatment of creatine deficiency syndromes, 19/02/2021, Positive (updated)
06/02/2023 Other: Article 57 product data (updated)
06/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), PM: decision on the application for modification of an agreed PIP, P/0367/2018 (updated)
06/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-carboxylic acids, PM: decision on the application for modification of an agreed PIP, P/0377/2017 (updated)
06/02/2023 Product Management Service (PMS) Webinar on Data Migration , Online, 14:00 - 15:30 Amsterdam time (CEST), from 23/02/2023 to 23/02/2023
06/02/2023 Human medicines European public assessment report (EPAR): Plerixafor Accord, Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation, 16/12/2022, Additional monitoring, Generic, Authorised
06/02/2023 News and press releases: Actions to support the development of medicines for children
06/02/2023 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine, tenofovir disoproxil maleate, HIV Infections, 16/12/2016, Generic, 12, Authorised (updated)
06/02/2023 Human medicines European public assessment report (EPAR): Flixabi, infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Arthritis, Rheumatoid; Crohn Disease; Psoriasis, 26/05/2016, Biosimilar, 23, Authorised (updated)
06/02/2023 Orphan designation: polyethylene glycol-modified human recombinant truncated cystathionine beta-synthase (pegtibatinase) for the: Treatment of homocystinuria, 30/05/2016, Positive (updated)
06/02/2023 ICH Q9 Quality risk management - Scientific guideline (updated)
06/02/2023 Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q9 (R1) on quality risk management - Step 5 - Revision 1
06/02/2023 Work programme: CHMP work plan 2023
06/02/2023 Newsletter: Human medicines highlights - February 2023
06/02/2023 Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)
06/02/2023 Other: List of signals discussed at PRAC since September 2012 (updated)
06/02/2023 Work programme: Consolidated 3-year work plan for the Methodology Working Party (MWP)
06/02/2023 Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 May 2022 , European Medicines Agency, Amsterdam, the Netherlands, from 02/05/2022 to 05/05/2022 (updated)
06/02/2023 Minutes: Minutes of the PRAC meeting 2-5 May 2022
06/02/2023 Human medicines European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG, influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks, 16/10/2009, Exceptional circumstances, 8, Authorised (updated)
03/02/2023 Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), CX-024414 (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, 35, Authorised (updated)
03/02/2023 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, 38, Authorised (updated)
03/02/2023 EMA virtual technical media briefing on the RNA technology , Online, 10:00 - 10:45 Amsterdam time (CET), from 03/02/2023 to 03/02/2023
03/02/2023 Procurement (updated)
03/02/2023 News and press releases: Public consultation on a multi-stakeholder platform to improve clinical trials in the EU
03/02/2023 Scientific guideline: Priority Action 3 concept paper: an EU multi-stakeholder platform for improving clinical trials - Accelerating Clinical Trials in the European Union (ACT EU)
03/02/2023 Human medicines European public assessment report (EPAR): Darunavir Krka d.d., darunavir, HIV Infections, 18/01/2018, Generic, 8, Withdrawn (updated)
03/02/2023 News and press releases: EMA Committee on Herbal Medicinal Products re-elects Emiel van Galen as Chair
03/02/2023 Other: Scientific recommendations on classification of advanced therapy medicinal products (October - December 2022)
02/02/2023 Other: Timeline: European Medicines Agency-FDA parallel scientific advice (updated)
02/02/2023 Withdrawn application: Gavreto, pralsetinib, Date of withdrawal: 03/11/2022, Post-authorisation (updated)
02/02/2023 Plasma master file certificates (updated)
02/02/2023 Crisis preparedness and management (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Truvada, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 20/02/2005, 46, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Stribild, elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 24/05/2013, 25, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Bemrist Breezhaler, indacaterol, Mometasone furoate, Asthma, 30/05/2020, 5, Authorised (updated)
02/02/2023 EPAR - Assessment report - Variation: Bemrist Breezhaler-H-C-005516-P46-002 : EPAR - Assessment Report
02/02/2023 Withdrawn application: Olumiant, baricitinib, Date of withdrawal: 07/12/2022, Post-authorisation (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Atectura Breezhaler, indacaterol acetate, Mometasone furoate, Asthma, 30/05/2020, 7, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Lynparza, Olaparib, Ovarian Neoplasms, 16/12/2014, 19, Authorised (updated)
02/02/2023 EPAR - Assessment report - Variation: Atectura Breezhaler-H-C-005067-P46-002 : EPAR - Assessment Report
02/02/2023 Human medicines European public assessment report (EPAR): DuoPlavin, clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome; Myocardial Infarction, 14/03/2010, 27, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Karvezide, irbesartan, hydrochlorothiazide, Hypertension, 16/10/1998, 44, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Segluromet, ertugliflozin l-pyroglutamic acid, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/03/2018, 6, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Lyxumia , lixisenatide, Diabetes Mellitus, Type 2, 31/01/2013, 17, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Veklury, remdesivir, Coronavirus Infections, 03/07/2020, Additional monitoring, 17, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Praluent, Alirocumab, Dyslipidemias, 23/09/2015, 19, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Ceprotin, human protein C, Purpura Fulminans; Protein C Deficiency, 16/07/2001, 18, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Revinty Ellipta, fluticasone furoate, vilanterol trifenatate, Asthma, 02/05/2014, 21, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Karvea, irbesartan, Hypertension, 26/08/1997, 45, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Relvar Ellipta, fluticasone furoate, vilanterol, Pulmonary Disease, Chronic Obstructive, 13/11/2013, 24, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Blitzima, rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell, 13/07/2017, Biosimilar, 18, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Locametz, gozetotide, Radionuclide Imaging, 09/12/2022, 1, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Juluca, dolutegravir sodium, rilpivirine hydrochloride, HIV Infections, 16/05/2018, 14, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing, 14/01/2015, 28, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Tesavel, sitagliptin, Diabetes Mellitus, Type 2, 10/01/2008, 27, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Pluvicto, lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant, 09/12/2022, Additional monitoring, 1, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): ellaOne, ulipristal, Contraception, Postcoital, 15/05/2009, 27, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Helicobacter Test INFAI, urea (13C), Breath Tests; Helicobacter Infections, 14/08/1997, 20, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Prometax, rivastigmine, Alzheimer Disease; Parkinson Disease; Dementia, 03/12/1998, 44, Authorised (updated)
02/02/2023 European Union (EU) International Organisation for Standardization (ISO) for identification of medical products (IDMP)/Substance, Product, Organisation and Referential (SPOR) data Task Force meeting - January 2023 , European Medicines Agency, Amsterdam, the Netherlands, from 26/01/2023 to 26/01/2023
02/02/2023 Orphan designation: Volanesorsen sodium for the: Treatment of familial partial lipodystrophy, 14/07/2016, Positive (updated)
02/02/2023 Orphan designation: Phosphorothioate oligonucleotide targeted to apolipoprotein C-III (volanesorsen) for the: Treatment of familial chylomicronaemia syndrome, 19/02/2014, Positive (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Siklos, hydroxycarbamide, Anemia, Sickle Cell, 29/06/2007, 23, Authorised (updated)
02/02/2023 Human medicines European public assessment report (EPAR): Exelon, rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease, 11/05/1998, 45, Authorised (updated)
01/02/2023 Variations not requiring assessment (veterinary medicines) (updated)
01/02/2023 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 10:00 - 12:00 Amsterdam time (CEST), from 11/11/2022 to 11/11/2022 (updated)
01/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Lokelma, sodium zirconium cyclosilicate, PM: decision on the application for modification of an agreed PIP, P/0477/2021 (updated)
01/02/2023 Clinical evaluation of new vaccines - Scientific guideline (updated)
01/02/2023 PRIME: priority medicines (updated)
01/02/2023 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 23-26 January 2023
01/02/2023 Report: List of products granted eligibility to PRIME (updated)
01/02/2023 Report: CAT quarterly highlights and approved ATMPs - January 2023
01/02/2023 Other: Application of EMA’s transparency principles to the raw data proof-of-concept pilot
01/02/2023 Human medicines European public assessment report (EPAR): Caprelsa, Vandetanib, Thyroid Neoplasms, 16/02/2012, Conditional approval, 23, Authorised (updated)
01/02/2023 Human medicines European public assessment report (EPAR): Xolair, omalizumab, Asthma; Urticaria, 25/10/2005, 44, Authorised (updated)
01/02/2023 Human medicines European public assessment report (EPAR): Ninlaro, ixazomib citrate, Multiple Myeloma, 21/11/2016, Orphan, Additional monitoring, Conditional approval, 15, Authorised (updated)
01/02/2023 Human medicines European public assessment report (EPAR): Ogluo, Glucagon, Diabetes Mellitus, 11/02/2021, 4, Authorised (updated)
01/02/2023 Agenda: Agenda of the HMPC meeting 23-25 January 2023 (updated)
01/02/2023 EMA/HMA Big Data Stakeholder Forum 2022 , Online, 9:00 - 17:55 Amsterdam time (CET), from 01/12/2022 to 01/12/2022 (updated)
01/02/2023 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 09:30 - 11:30 Amsterdam time (CEST), from 11/01/2023 to 11/01/2023 (updated)
01/02/2023 Certification procedures for micro-, small- and medium-sized enterprises (SMEs) (updated)
01/02/2023 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
01/02/2023 Administration and Corporate Management (updated)
01/02/2023 Other: Organisation chart: Administration and Corporate Management (updated)