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Date	Content
13/02/2023	Human medicines European public assessment report (EPAR): Nulojix, belatacept, Graft Rejection; Kidney Transplantation, 17/06/2011, 20, Authorised
13/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Ganaxolone, PM: decision on the application for modification of an agreed PIP, P/0404/2021
13/02/2023	Human medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors, 26/09/2017, , 9, Authorised
13/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Kaftrio, elexacaftor,tezacaftor,ivacaftor, PM: decision on the application for modification of an agreed PIP, P/0416/2021
13/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Doxylamine (succinate),pyridoxine (hydrochloride), W: decision granting a waiver in all age groups for all conditions or indications, P/0410/2021
13/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Alunbrig, brigatinib, PM: decision on the application for modification of an agreed PIP, P/0405/2021
13/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Trulicity, dulaglutide, PM: decision on the application for modification of an agreed PIP, P/0409/2021
13/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): drospirenone, W: decision granting a waiver in all age groups for all conditions or indications, P/0451/2021
13/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Byfavo, Remimazolam (as besilate), PM: decision on the application for modification of an agreed PIP, P/0427/2021
13/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human glutamic acid decarboxylase (rhGAD65), PM: decision on the application for modification of an agreed PIP, P/0441/2021
13/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Trajenta, linagliptin, PM: decision on the application for modification of an agreed PIP, P/0446/2021
13/02/2023	EMA/HMA Big Data Stakeholder Forum 2022 , Online, 9:00 - 17:55 Amsterdam time (CET), from 01/12/2022 to 01/12/2022
13/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Calquence, Acalabrutinib, PM: decision on the application for modification of an agreed PIP, P/0408/2021
13/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Oxalobacter formigenes strain HC-1, PM: decision on the application for modification of an agreed PIP, P/0447/2021
13/02/2023	Human medicines European public assessment report (EPAR): Tavneos, Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis, 11/01/2022, , , 2, Authorised
13/02/2023	Human medicines European public assessment report (EPAR): Azacitidine betapharm, azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute, 24/03/2020, , 5, Authorised
13/02/2023	Human medicines European public assessment report (EPAR): Tracleer, bosentan (as monohydrate), Scleroderma, Systemic; Hypertension, Pulmonary, 14/05/2002, 42, Authorised
13/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe,Rosuvastatin, W: decision granting a waiver in all age groups for all conditions or indications, P/0411/2021
13/02/2023	Human medicines European public assessment report (EPAR): Stayveer, bosentan (as monohydrate), Hypertension, Pulmonary; Scleroderma, Systemic, 24/06/2013, 15, Authorised
10/02/2023	Human medicines European public assessment report (EPAR): Filgrastim Hexal, filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer, 06/02/2009, , 21, Authorised
10/02/2023	Human medicines European public assessment report (EPAR): Zarzio, filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer, 06/02/2009, , 22, Authorised
10/02/2023	Periodic safety update single assessment: Germanium (68Ge) chloride / gallium (68Ga) chloride : List of nationally authorised medicinal products - PSUSA/00010364/202203
10/02/2023	Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants , Online, 13:00 - 17:00 Amsterdam time (CET), from 15/12/2022 to 15/12/2022
10/02/2023	Periodic safety update single assessment: Human coagulation factor XIII : List of nationally authorised medicinal products - PSUSA/00001622/202206
10/02/2023	Human medicines European public assessment report (EPAR): Eylea, aflibercept, Wet Macular Degeneration; Macular Edema; Diabetes Complications, 21/11/2012, 28, Authorised
10/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Ozempic, semaglutide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0464/2021
10/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab, RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0466/2021
10/02/2023	Periodic safety update single assessment: Nitrous oxide, nitrous oxide / oxygen - List of nationally authorised medicinal products - PSUSA/00010572/202206
10/02/2023	Withdrawn application: Aliqopa, copanlisib, Date of withdrawal: 20/12/2021, Initial authorisation
10/02/2023	Periodic safety update single assessment: Sulfamethizole - List of nationally authorised medicinal products - PSUSA/00010561/202206
10/02/2023	Other: Timetable: Initial (full) marketing authorisation application assessment
10/02/2023	Periodic safety update single assessment: Apis mellifera (801) (with or without adjuvant), Apis mellifera venom - List of nationally authorised medicinal products - PSUSA/00010722/202207
10/02/2023	Other: Timetable: Extension application
10/02/2023	Periodic safety update single assessment: Methylaminolevulinate : List of nationally authorised medicinal products - PSUSA/00002019/202206
10/02/2023	Other: Timetable: Type II variation and worksharing application monthly assessment
10/02/2023	Periodic safety update single assessment: Theophylline - List of nationally authorised medicinal products - PSUSA/00002921/202206
10/02/2023	News and press releases: PRAC starts safety review of pseudoephedrine-containing medicines
10/02/2023	News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 - 9 February 2023
10/02/2023	Periodic safety update single assessment: Allergen for diagnostic and or therapy Vespula SPP. (802) (with or without adjuvant), Wasp venom - nationally authorised product only) - List of nationally authorised medicinal products - PSUSA/00010721/202207
10/02/2023	Periodic safety update single assessment: Pentamidine : List of nationally authorised medicinal products - PSUSA/00002338/202206
10/02/2023	Periodic safety update single assessment: Ganciclovir : List of nationally authorised medicinal products - PSUSA/00001516/202206
10/02/2023	Periodic safety update single assessment: Cilastatin / Imipenem : List of nationally authorised medicinal products - PSUSA/00000748/202206
10/02/2023	Periodic safety update single assessment: Amorolfine : List of nationally authorised medicinal products - PSUSA/00000185/202206
10/02/2023	Regulatory and procedural guideline: Validation checklist for Type II quality variations
10/02/2023	EMA regular press briefing on public health emergencies , Online, 14:00 - 14:30 Amsterdam time (CET), from 15/02/2023 to 15/02/2023
09/02/2023	Agenda: Agenda - Regulatory and scientific virtual conference on RNA-based medicines
09/02/2023	Periodic safety update single assessment: Acamprosate : List of nationally authorised medicinal products - PSUSA/00000016/202207
09/02/2023	Other: Note on European Medicines Agency’s involvement in HORIZON-HLTH-2023-TOOL-05-09: Developing a Data Quality and Utility Label for the European Health Data Space
09/02/2023	Human medicines European public assessment report (EPAR): Zercepac, trastuzumab, Breast Neoplasms; Stomach Neoplasms, 27/07/2020, , , 8, Authorised
09/02/2023	Human medicines European public assessment report (EPAR): Sylvant, siltuximab, Giant Lymph Node Hyperplasia, 22/05/2014, , , 12, Authorised
09/02/2023	Human medicines European public assessment report (EPAR): Hemangiol, propranolol hydrochloride, Hemangioma, 23/04/2014, 6, Authorised
09/02/2023	Public health threats
09/02/2023	Human medicines European public assessment report (EPAR): Harvoni, ledipasvir, Sofosbuvir, Hepatitis C, Chronic, 17/11/2014, , 27, Authorised
09/02/2023	Human medicines European public assessment report (EPAR): Sovaldi, Sofosbuvir, Hepatitis C, Chronic, 16/01/2014, , 27, Authorised
09/02/2023	Human medicines European public assessment report (EPAR): Defitelio, defibrotide, Hepatic Veno-Occlusive Disease, 18/10/2013, , , , 14, Authorised
09/02/2023	Substance and product data management services
09/02/2023	Human medicines European public assessment report (EPAR): Pregabalin Zentiva, pregabalin, Anxiety Disorders; Epilepsy, 17/07/2015, , 15, Authorised
09/02/2023	Human medicines European public assessment report (EPAR): Vosevi, Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic, 26/07/2017, 14, Authorised
09/02/2023	Human medicines European public assessment report (EPAR): Fluenz Tetra, A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444, Influenza, Human, 04/12/2013, 23, Authorised
08/02/2023	Periodic safety update single assessment: Moclobemide : List of nationally authorised medicinal products - PSUSA/00002079/202204
08/02/2023	Human medicines European public assessment report (EPAR): Spevigo, Spesolimab, Psoriasis, 09/12/2022, , , Authorised
08/02/2023	DARWIN EU Advisory Board meeting: 6 February 2023 , Online, 10:00 - 12:00 Amsterdam time (CET), from 06/02/2023 to 06/02/2023
08/02/2023	DARWIN EU Advisory Board meeting: 8 September 2022 , Online, 15:00 - 17:00 Amsterdam time (CET), from 08/09/2022 to 08/09/2022
08/02/2023	Agenda: Agenda of the COMP meeting 14-16 February 2023
08/02/2023	Other: Consolidated 3-year work plan for the Non-clinical domain including the priorities for 2023
08/02/2023	Withdrawn application: Miplyffa , arimoclomol, Date of withdrawal: 22/03/2022, Initial authorisation
08/02/2023	Direct healthcare professional communication (DHPC): Amfepramone-containing medicines will no longer be available on the EU market, as marketing authorisations will be revoked, Active substance: amfepramone, DHPC type: Referral - Article 31, Last updated: 08/02/2023
07/02/2023	Scientific guideline: ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Step 2b
07/02/2023	Fourth Nitrosamine Implementation Oversight Group (NIOG) meeting , from 30/11/2022 to 30/11/2022
07/02/2023	Human medicines European public assessment report (EPAR): Lupkynis, Voclosporin, Lupus Nephritis, 15/09/2022, , 1, Authorised
07/02/2023	Work programme: COMP work plan 2023
07/02/2023	Committee for Orphan Medicinal Products (COMP)
07/02/2023	Vaccine Monitoring Platform
07/02/2023	Withdrawn application: Imbarkyd, bardoxolone methyl, Date of withdrawal: 09/11/2022, Initial authorisation
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	Orphan designation: Berzosertib for the: Treatment of small cell lung cancer, 18/07/2022, Withdrawn
07/02/2023	Orphan designation: Rebastinib for the: Treatment of ovarian cancer, 12/11/2021, Positive
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	EPAR - Assessment report - Variation: Dupixent-H-C-4390-P46-007 : EPAR - Assessment Report
06/02/2023	News and press releases: EMA update on shortages of antibiotics in the EU
06/02/2023	Supply shortage: Amoxicillin and amoxicillin/clavulanic acid supply shortage
06/02/2023	Orphan designation: Dodecyl creatine ester, dodecyl creatine ester hydrochloride for the: Treatment of creatine deficiency syndromes, 19/02/2021, Positive
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
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
06/02/2023	Human medicines European public assessment report (EPAR): Plerixafor Accord, Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation, 16/12/2022, , , 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, , 12, Authorised
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, , 23, Authorised
06/02/2023	Orphan designation: polyethylene glycol-modified human recombinant truncated cystathionine beta-synthase (pegtibatinase) for the: Treatment of homocystinuria, 30/05/2016, Positive
06/02/2023	ICH Q9 Quality risk management - Scientific guideline
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	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
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, , 8, Authorised
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	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	Other: Priority Action 10: Training strategy - 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, , 8, Withdrawn
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 (January 2021 – December 2022)
02/02/2023	Other: Timeline: European Medicines Agency-FDA parallel scientific advice
02/02/2023	Withdrawn application: Gavreto, pralsetinib, Date of withdrawal: 03/11/2022, Post-authorisation
02/02/2023	Crisis preparedness and management
02/02/2023	Human medicines European public assessment report (EPAR): Truvada, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 20/02/2005, 46, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Stribild, elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 24/05/2013, 25, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Bemrist Breezhaler, indacaterol, Mometasone furoate, Asthma, 30/05/2020, 5, Authorised
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
02/02/2023	Human medicines European public assessment report (EPAR): Atectura Breezhaler, indacaterol acetate, Mometasone furoate, Asthma, 30/05/2020, 7, Authorised
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): Segluromet, ertugliflozin l-pyroglutamic acid, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/03/2018, 6, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Lyxumia , lixisenatide, Diabetes Mellitus, Type 2, 31/01/2013, 17, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Praluent, Alirocumab, Dyslipidemias, 23/09/2015, 19, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Ceprotin, human protein C, Purpura Fulminans; Protein C Deficiency, 16/07/2001, 18, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Revinty Ellipta, fluticasone furoate, vilanterol trifenatate, Asthma, 02/05/2014, 21, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Karvea, irbesartan, Hypertension, 26/08/1997, 45, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Relvar Ellipta, fluticasone furoate, vilanterol, Pulmonary Disease, Chronic Obstructive, 13/11/2013, 24, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Blitzima, rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell, 13/07/2017, , 18, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Locametz, gozetotide, Radionuclide Imaging, 09/12/2022, 1, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Juluca, dolutegravir sodium, rilpivirine hydrochloride, HIV Infections, 16/05/2018, 14, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Tesavel, sitagliptin, Diabetes Mellitus, Type 2, 10/01/2008, 27, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Helicobacter Test INFAI, urea (13C), Breath Tests; Helicobacter Infections, 14/08/1997, 20, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Prometax, rivastigmine, Alzheimer Disease; Parkinson Disease; Dementia, 03/12/1998, 44, Authorised
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
02/02/2023	Orphan designation: Phosphorothioate oligonucleotide targeted to apolipoprotein C-III (volanesorsen) for the: Treatment of familial chylomicronaemia syndrome, 19/02/2014, Positive
02/02/2023	Human medicines European public assessment report (EPAR): Siklos, hydroxycarbamide, Anemia, Sickle Cell, 29/06/2007, 23, Authorised
02/02/2023	Human medicines European public assessment report (EPAR): Exelon, rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease, 11/05/1998, 45, Authorised
01/02/2023	Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 10:00 - 12:00 Amsterdam time (CET), from 11/11/2022 to 11/11/2022
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
01/02/2023	Clinical evaluation of new vaccines - Scientific guideline
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: 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): Ninlaro, ixazomib citrate, Multiple Myeloma, 21/11/2016, , , , 15, Authorised
01/02/2023	Agenda: Agenda of the HMPC meeting 23-25 January 2023
01/02/2023	Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 09:30 - 11:30 Amsterdam time (CET), from 11/01/2023 to 11/01/2023
01/02/2023	Certification procedures for micro-, small- and medium-sized enterprises (SMEs)