18/03/2024 | Page: Transferring a veterinary marketing authorisation | Updated |
18/03/2024 | Page: EudraVigilance system overview | Updated |
18/03/2024 | Document: Template - Application for transfer of marketing authorisation from transferor to transferee, cover letter | New |
18/03/2024 | Document: Template - Application for transfer of marketing authorisation from transferor to transferee, attachment 2 | New |
18/03/2024 | Event: Product Management Service (PMS) Info-Day | New |
18/03/2024 | Document: Template - Application for transfer of marketing authorisation from transferor to transferee, attachment 1 | New |
18/03/2024 | Event: Orphan medicines development - ask the European regulator | Updated |
18/03/2024 | Medicine: Vimpat | Updated |
18/03/2024 | Medicine: Nobilis Multriva RT+IBm+ND+Gm+REOm+EDS | New |
18/03/2024 | Medicine: Trilocur | New |
18/03/2024 | Medicine: Divence Tetra | New |
18/03/2024 | Medicine: Lotimax | New |
18/03/2024 | Medicine: Trilorale | New |
18/03/2024 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-13 March 2024 | New |
18/03/2024 | Post-authorisation: Prevexxion RN+HVT+IBD - opinion on variation to marketing authorisation | New |
18/03/2024 | Page: Website outages and upgrades | Updated |
18/03/2024 | Medicine: Epysqli | Updated |
18/03/2024 | Page: Union Product Database: release notes | Updated |
18/03/2024 | Document: Agenda of the CHMP meeting 18-21 March 2024 | New |
15/03/2024 | Medicine: Bosulif | Updated |
15/03/2024 | Medicine: Phelinun | Updated |
15/03/2024 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - March 2024 | Updated |
15/03/2024 | Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting | Updated |
15/03/2024 | Medicine: Accofil | Updated |
15/03/2024 | Medicine: Skyrizi | Updated |
15/03/2024 | Page: Scientific publications | Updated |
15/03/2024 | PSUSA: PSUSA/00002060/202305 - periodic safety update report single assessment | New |
15/03/2024 | Medicine: VidPrevtyn Beta | Updated |
14/03/2024 | Page: Industry annual bilateral meetings | Updated |
14/03/2024 | Event: Third European Medicines Agency (EMA) and MedTech Europe bilateral meeting | Updated |
14/03/2024 | Page: Union Product Database | Updated |
14/03/2024 | Document: Record of data processing activity relating to Security Access Control System (public) | Updated |
14/03/2024 | Medicine: Lacosamide Adroiq | Updated |
14/03/2024 | Document: New Organization First User QPPV/RP or Change of EU QPPV/RP | Updated |
14/03/2024 | Medicine: Methylthioninium chloride Proveblue | Updated |
14/03/2024 | Document: EudraVigilance registration documents | Updated |
14/03/2024 | Document: EudraVigilance registration manual | Updated |
14/03/2024 | Page: Data protection and privacy | Updated |
14/03/2024 | Medicine: Paxlovid | Updated |
14/03/2024 | Medicine: Talvey | Updated |
14/03/2024 | Document: Record of data processing activity relating to personal files (public) | Updated |
14/03/2024 | Document: European Medicines Agency’s privacy statement for the operation of the Security Access Control System | Updated |
14/03/2024 | Event: EMA Veterinary Medicines Info Day 2024 | Updated |
14/03/2024 | Medicine: Vijoice | Updated |
14/03/2024 | PSUSA: PSUSA/00010271/202307 - periodic safety update report single assessment | New |
14/03/2024 | Medicine: Retsevmo | Updated |
14/03/2024 | Medicine: Sustiva | Updated |
13/03/2024 | PIP: EMEA-001214-PIP07-21 - paediatric investigation plan | New |
13/03/2024 | Document: Member states contact points for translations review | Updated |
13/03/2024 | PIP: EMEA-001214-PIP04-19 - paediatric investigation plan | New |
13/03/2024 | PIP: EMEA-002229-PIP02-21 - paediatric investigation plan | New |
13/03/2024 | Page: Eligible patients and consumers organisations | Updated |
13/03/2024 | PIP: EMEA-002239-PIP02-21 - paediatric investigation plan | New |
13/03/2024 | PIP: EMEA-001196-PIP03-21 - paediatric investigation plan | New |
13/03/2024 | Medicine: Imjudo | Updated |
13/03/2024 | PIP: EMEA-002431-PIP02-21 - paediatric investigation plan | New |
13/03/2024 | Page: Proline - Scientific guideline | Updated |
13/03/2024 | Page: Supporting innovation | Updated |
13/03/2024 | PIP: EMEA-002839-PIP01-20-M01 - paediatric investigation plan | Updated |
13/03/2024 | Event: Quarterly System Demo Q1 2024 | Updated |
13/03/2024 | PIP: EMEA-002700-PIP01-19-M01 - paediatric investigation plan | Updated |
13/03/2024 | Event: EMA and European Organisation for Research and Treatment of Cancer (EORTC) workshop: How can patient-reported outcomes (PRO) and health-related quality of life (HRQoL) data inform regulatory decisions? | Updated |
13/03/2024 | Medicine: Xevudy | Updated |
13/03/2024 | Medicine: Vaxzevria (previously COVID-19 Vaccine AstraZeneca) | Updated |
13/03/2024 | Medicine: Blenrep | Updated |
13/03/2024 | Medicine: Ilaris | Updated |
13/03/2024 | Document: Blenrep : EPAR - Public assessment report | Updated |
13/03/2024 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
13/03/2024 | Medicine: Krazati | Updated |
13/03/2024 | Document: Innovation Task Force (ITF) briefing meeting request form | Updated |
13/03/2024 | Event: Paediatric Committee (PDCO): 16-19 January 2024 | Updated |
13/03/2024 | Event: Committee for Advanced Therapies (CAT): 13-15 March 2024 | Updated |
13/03/2024 | Orphan: EU/3/05/314 - orphan designation for treatment of tuberculosis | Updated |
13/03/2024 | Medicine: Sirturo | Updated |
12/03/2024 | Event: Multi-stakeholder workshop on Data Quality Framework for Adverse Drug Reaction reporting | Updated |
12/03/2024 | Event: CTIS Bitesize Talk: How to submit a transitional trial in CTIS | Updated |
12/03/2024 | Medicine: Pomalidomide Viatris | Updated |
12/03/2024 | Medicine: Prevenar 20 (previously Apexxnar) | Updated |
12/03/2024 | PSUSA: PSUSA/00000906/202305 - periodic safety update report single assessment | New |
12/03/2024 | PSUSA: PSUSA/00010913/202306 - periodic safety update report single assessment | New |
12/03/2024 | Medicine: Striascan | Updated |
12/03/2024 | Page: Coordination of pharmacovigilance inspections | Updated |
12/03/2024 | Document: Applications for new human medicines under evaluation: March 2024 | New |
12/03/2024 | Document: DARWIN EU Advisory Board: Membership | Updated |
12/03/2024 | Medicine: Ibuprofen Gen.Orph | Updated |
12/03/2024 | Medicine: Evkeeza | Updated |
12/03/2024 | Medicine: Daxas | Updated |
12/03/2024 | Medicine: Verzenios | Updated |
12/03/2024 | Medicine: Kaftrio | Updated |
12/03/2024 | Medicine: Idefirix | Updated |
11/03/2024 | Medicine: Pramipexole Accord | Updated |
11/03/2024 | Event: Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 March 2024 | Updated |
11/03/2024 | Medicine: Upstaza | Updated |
11/03/2024 | Medicine: Innovax-ILT-IBD | New |
11/03/2024 | Medicine: Prevexxion RN+HVT | New |
11/03/2024 | Medicine: Eurican L4 | New |
11/03/2024 | Medicine: Xultophy | Updated |
11/03/2024 | Medicine: Nexviadyme | Updated |
11/03/2024 | Medicine: Comirnaty | Updated |
11/03/2024 | Herbal: Symphyti radix - herbal medicinal product | Updated |
11/03/2024 | Document: Agenda of the COMP meeting 12-14 March 2024 | New |
11/03/2024 | Event: Committee for Medicinal Products for Human Use (CHMP): 22-25 January 2024 | Updated |
11/03/2024 | Page: Product-specific bioequivalence guidance | Updated |
11/03/2024 | Document: Minutes of the CHMP meeting 22-25 January 2024 | New |
11/03/2024 | Document: Procedural advice for orphan medicinal product designation: Guidance for sponsors | Updated |
11/03/2024 | Document: Fludarabine supply shortage | New |
08/03/2024 | Medicine: Emend | Updated |
08/03/2024 | PSUSA: PSUSA/00010007/202307 - periodic safety update report single assessment | New |
08/03/2024 | Medicine: Prevenar 13 | Updated |
08/03/2024 | PIP: EMEA-001397-PIP04-17-M01 - paediatric investigation plan | Updated |
08/03/2024 | PIP: EMEA-001312-PIP02-19 - paediatric investigation plan | Updated |
08/03/2024 | PIP: EMEA-001312-PIP03-19 - paediatric investigation plan | Updated |
08/03/2024 | PSUSA: PSUSA/00001738/202307 - periodic safety update report single assessment | New |
08/03/2024 | Medicine: Zalasta | Updated |
08/03/2024 | Medicine: Kinpeygo | Updated |
08/03/2024 | Medicine: Skyclarys | Updated |
08/03/2024 | Medicine: Eliquis | Updated |
08/03/2024 | Medicine: Ivemend | Updated |
08/03/2024 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024 | New |
08/03/2024 | Medicine: Quofenix | Updated |
08/03/2024 | Medicine: HyQvia | Updated |
08/03/2024 | Page: Liposomal amphotericin B product-specific bioequivalence guidance | Updated |
08/03/2024 | Document: Note on the HORIZON-JU-IHI-2024-06-two-stage funding call: Development of evidence based practical guidance for sponsors on the use of real-world data / real-world evidence | New |
07/03/2024 | Page: Scientific and technical recommendations: Veterinary Medicines Regulation | Updated |
07/03/2024 | Document: EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance | Updated |
07/03/2024 | Document: EudraVigilance Form A | Updated |
07/03/2024 | Document: Connection template - EMA ESTRI Gateway using an AS2 compatible product | Updated |
07/03/2024 | Document: Connecting to the Agency ESTRI Gateway using an AS2 compatible product | Updated |
07/03/2024 | Document: Vendor registration in the EudraVigilance external compliance testing environment (XCOMP) - Registration procedure | Updated |
07/03/2024 | Document: EudraVigilance - EVWEB user manual | Updated |
07/03/2024 | Document: EudraVigilance support guide | Updated |
07/03/2024 | PSUSA: PSUSA/00002151/202308 - periodic safety update report single assessment | New |
07/03/2024 | PSUSA: PSUSA/00011039/202307 - periodic safety update report single assessment | New |
07/03/2024 | PSUSA: PSUSA/00000210/202308 - periodic safety update report single assessment | New |
07/03/2024 | Page: Vaccine Monitoring Platform | Updated |
07/03/2024 | Medicine: Imbruvica | Updated |
07/03/2024 | PIP: EMEA-002440-PIP01-18-M04 - paediatric investigation plan | Updated |
07/03/2024 | Document: Vaccine Monitoring Platform: List of EMA-funded studies | New |
07/03/2024 | Event: Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studies | Updated |
07/03/2024 | PIP: EMEA-002435-PIP01-18-M03 - paediatric investigation plan | Updated |
07/03/2024 | PIP: EMEA-002298-PIP01-17-M05 - paediatric investigation plan | Updated |
07/03/2024 | Medicine: Mekinist | Updated |
07/03/2024 | Document: Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2024-2025 | Updated |
07/03/2024 | Medicine: Tafinlar | Updated |
07/03/2024 | Document: Meeting Report of the second Listen and Learn Focus Group (LLFG) meeting of the Quality Innovation Group (QIG) | New |
07/03/2024 | Page: Big data | Updated |
07/03/2024 | Document: Final Minutes – HMA-EMA joint Big Data Steering Group teleconference - 30 January 2024 | New |
07/03/2024 | Event: 3Rs Working Party (3RsWP) plenary meeting – Public session on the 2024 work plan | Updated |
07/03/2024 | PIP: EMEA-003341-PIP01-22 - paediatric investigation plan | New |
07/03/2024 | PIP: EMEA-003342-PIP01-22 - paediatric investigation plan | New |
07/03/2024 | PIP: EMEA-003340-PIP01-22 - paediatric investigation plan | New |
07/03/2024 | Page: Opinions and letters of support on the qualification of novel methodologies for medicine development | Updated |
06/03/2024 | Medicine: Mounjaro | Updated |
06/03/2024 | Medicine: Apealea | Updated |
06/03/2024 | Medicine: Doptelet | Updated |
06/03/2024 | Medicine: Revestive | Updated |
06/03/2024 | Page: Data Analysis and Real World Interrogation Network (DARWIN EU) | Updated |
06/03/2024 | Document: DARWIN EU data partners onboarded in phases I and II | Updated |
06/03/2024 | Document: DARWIN EU: Making health data count | New |
06/03/2024 | News: DARWIN EU® continues expanding its capacity to deliver real-world data studies | New |
06/03/2024 | PSUSA: PSUSA/00001504/202304 - periodic safety update report single assessment | New |
06/03/2024 | Medicine: Cholib | Updated |
06/03/2024 | Document: List of signals discussed at PRAC since September 2012 | Updated |
06/03/2024 | Document: PRAC recommendations on signals adopted at the 5-8 February 2024 PRAC meeting | New |
05/03/2024 | Medicine: Filspari | Updated |
05/03/2024 | Medicine: Dynastat | Updated |
05/03/2024 | Medicine: VeraSeal | Updated |
05/03/2024 | Herbal: Silybi mariani fructus - herbal medicinal product | Updated |
05/03/2024 | Document: Minutes of the PRAC meeting 8-11 January 2024 | New |
05/03/2024 | Medicine: Enhertu | Updated |
05/03/2024 | Page: Templates for assessors | Updated |
05/03/2024 | Document: CHMP rapporteurs' assessment report for paediatric studies submitted in accordance with Article 46 | Updated |
05/03/2024 | Document: Assessment report for post-authorisation measures (PAMs) | Updated |
05/03/2024 | Medicine: Clopidogrel TAD | Updated |
05/03/2024 | Medicine: Imcivree | Updated |
05/03/2024 | Medicine: Kalydeco | Updated |
05/03/2024 | Medicine: Ameluz | Updated |
05/03/2024 | Medicine: Vafseo | Updated |
05/03/2024 | Event: Sixth European Medicines Agency (EMA) and EFPIA bilateral meeting | Updated |
05/03/2024 | Medicine: Otezla | Updated |
05/03/2024 | Medicine: Dupixent | Updated |
05/03/2024 | Document: CHMP PROM minutes for the meeting on 12 February 2024 | New |
05/03/2024 | Document: CHMP PROM minutes for the meeting on 15 January 2024 | New |
04/03/2024 | Medicine: Aclasta | Updated |
04/03/2024 | PSUSA: PSUSA/00001506/202304 - periodic safety update report single assessment | New |
04/03/2024 | Document: Agenda of the PRAC meeting 4-7 March 2024 | New |
04/03/2024 | Medicine: Zyclara | Updated |
04/03/2024 | Event: Eight Nitrosamine Implementation Oversight Group (NIOG) meeting | New |
04/03/2024 | Medicine: Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan) | Updated |
04/03/2024 | Page: Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' | Updated |
04/03/2024 | Event: Training webinar on the use of Scientific Explorer in scientific advice regulatory procedures | New |
04/03/2024 | EU-M4all: Dapivirine Vaginal Ring 25 mg | Updated |
04/03/2024 | Medicine: Reblozyl | Updated |
04/03/2024 | Page: Procedures for monograph and list entry establishment | Updated |
04/03/2024 | Herbal: Gentianae radix - herbal medicinal product | Updated |
04/03/2024 | Herbal: Calendulae flos - herbal medicinal product | Updated |
04/03/2024 | Herbal: Boldi folium - herbal medicinal product | Updated |
04/03/2024 | Herbal: Avenae herba - herbal medicinal product | Updated |
04/03/2024 | Herbal: Avenae fructus - herbal medicinal product | Updated |
01/03/2024 | Herbal: Lupuli flos - herbal medicinal product | Updated |
01/03/2024 | Herbal: Lini semen - herbal medicinal product | Updated |
01/03/2024 | Herbal: Combination: Thymi herba and Primulae radix - herbal medicinal product | Updated |
01/03/2024 | Herbal: Rusci rhizoma - herbal medicinal product | Updated |
01/03/2024 | Herbal: Sambuci flos - herbal medicinal product | Updated |
01/03/2024 | Document: ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1 | New |
01/03/2024 | PSUSA: PSUSA-00002110-202305 - periodic safety update report single assessment | New |
01/03/2024 | PSUSA: PSUSA/00000613/202305 - periodic safety update report single assessment | New |
01/03/2024 | PSUSA: PSUSA/00001500/202304 - periodic safety update report single assessment | New |
01/03/2024 | Medicine: Zinplava | Updated |
01/03/2024 | Medicine: MabThera | Updated |
01/03/2024 | Medicine: Rxulti | Updated |
01/03/2024 | Medicine: Blincyto | Updated |
01/03/2024 | Medicine: Saxenda | Updated |
01/03/2024 | Document: List of centrally authorised products requiring a notification of a change for update of annexes | Updated |
01/03/2024 | Medicine: Toviaz | Updated |
01/03/2024 | Herbal: Foeniculi dulcis fructus - herbal medicinal product | Updated |
01/03/2024 | Herbal: Foeniculi amari fructus - herbal medicinal product | Updated |
01/03/2024 | Document: QRD Appendix III to the Quality Review of Documents templates for human medicinal products (Cover page) | Updated |
01/03/2024 | Medicine: Aldara | Updated |
01/03/2024 | Page: Network Portfolio | Updated |
01/03/2024 | Medicine: Tepadina | Updated |
01/03/2024 | Document: Organisation chart: Information Management | Updated |
01/03/2024 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - January 2024 | Updated |
01/03/2024 | Document: Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (29 January 2024) | New |
01/03/2024 | Document: Shortage of Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed)) | Updated |
01/03/2024 | Document: Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 19-22 February 2024 | New |
01/03/2024 | Document: List of medicines currently in PRIME scheme | Updated |