08/05/2025 | Medicine: Carvykti | Updated |
08/05/2025 | Page: Careers | Updated |
08/05/2025 | Page: Who we are | Updated |
08/05/2025 | Document: EMA Gender equality plan 2025 - 2030 | New |
08/05/2025 | Medicine: Tuzulby | Updated |
08/05/2025 | Page: Opinions and letters of support on the qualification of novel methodologies for medicine development | Updated |
08/05/2025 | Document: Draft qualification opinion for Simcyp Simulator | New |
08/05/2025 | Medicine: Neupro | Updated |
08/05/2025 | Page: Supporting innovation | Updated |
08/05/2025 | Document: Process for the electronic submission of medicinal product information - Chapter 3 | Updated |
08/05/2025 | Document: European Medicines Agency Write PMS API implementation Guide (zip) | Updated |
08/05/2025 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 May 2025 | New |
08/05/2025 | Referral: Finasteride- and dutasteride-containing medicinal products - referral | Updated |
08/05/2025 | News: Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines | New |
08/05/2025 | Page: Questions and answers for biological medicinal products | Updated |
08/05/2025 | Referral: Ixchiq - referral | Updated |
08/05/2025 | Medicine: Givlaari | Updated |
08/05/2025 | Medicine: Vimpat | Updated |
08/05/2025 | Page: Good Manufacturing Practice (GMP) / Distribution Practice Practice (GDP) Inspectors Working Group | Updated |
08/05/2025 | Document: Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products | New |
08/05/2025 | Medicine: Tacforius | Updated |
08/05/2025 | Medicine: Synjardy | Updated |
08/05/2025 | Medicine: Tecentriq | Updated |
08/05/2025 | Medicine: Tremfya | Updated |
08/05/2025 | Medicine: Jentadueto | Updated |
08/05/2025 | Event: Pharmacovigilance Risk Assessment Committee (PRAC): 10 - 13 March 2025 | Updated |
08/05/2025 | Medicine: Kayfanda | Updated |
08/05/2025 | Medicine: Brukinsa | Updated |
07/05/2025 | PSUSA: PSUSA/00010239/202408 - periodic safety update report single assessment | New |
07/05/2025 | Medicine: Cibinqo | Updated |
07/05/2025 | Medicine: Firazyr | Updated |
07/05/2025 | Medicine: Finlee | Updated |
07/05/2025 | Medicine: Kymriah | Updated |
07/05/2025 | Medicine: Ongentys | Updated |
07/05/2025 | Medicine: Zepatier | Updated |
07/05/2025 | Medicine: Cabazitaxel Accord | Updated |
07/05/2025 | Medicine: Breyanzi | Updated |
07/05/2025 | News: Leveraging the power of data for public and animal health | New |
07/05/2025 | Page: Artificial intelligence | Updated |
07/05/2025 | Page: Network Data Steering Group (NDSG) | Updated |
07/05/2025 | Document: Network Data Steering Group workplan 2025-2028 | New |
07/05/2025 | News: EMA starts review of Ixchiq (live attenuated chikungunya vaccine) | New |
07/05/2025 | Medicine: Evenity | Updated |
07/05/2025 | Medicine: Vectibix | Updated |
07/05/2025 | Medicine: Daurismo | Updated |
07/05/2025 | News: EMA closed on 9 May | New |
07/05/2025 | Medicine: Zejula | Updated |
07/05/2025 | Medicine: Bavencio | Updated |
07/05/2025 | Document: Agenda - EMA’s 30th anniversary scientific conference | Updated |
07/05/2025 | Event: Workshop on the use of Bayesian statistics in clinical development | New |
07/05/2025 | Medicine: Urorec | Updated |
06/05/2025 | PSUSA: PSUSA/00010269/202407 - periodic safety update report single assessment | New |
06/05/2025 | PSUSA: PSUSA/00000761/202408 - periodic safety update report single assessment | New |
06/05/2025 | PSUSA: PSUSA/00010464/202407 - periodic safety update report single assessment | New |
06/05/2025 | Medicine: Vyjuvek | Updated |
06/05/2025 | Medicine: Herceptin | Updated |
06/05/2025 | Medicine: Ocrevus | Updated |
06/05/2025 | Medicine: Lunsumio | Updated |
06/05/2025 | Medicine: Xydalba | Updated |
06/05/2025 | Medicine: Roctavian | Updated |
06/05/2025 | Page: PRIME: priority medicines | Updated |
06/05/2025 | Document: List of medicines currently in PRIME scheme | Updated |
06/05/2025 | Medicine: Bortezomib Sun | Updated |
06/05/2025 | Medicine: Briumvi | Updated |
06/05/2025 | Medicine: RoActemra | Updated |
06/05/2025 | Medicine: Zolgensma | Updated |
06/05/2025 | Document: Standard operating procedure for assignment of micro-, small- or medium-sized-enterprise status | Updated |
06/05/2025 | Document: Standard operating procedure for renewal of micro-, small- or medium-sized-enterprise status | Updated |
06/05/2025 | Medicine: Mavenclad | Updated |
06/05/2025 | Medicine: Sitagliptin / Metformin hydrochloride Sun | Updated |
06/05/2025 | Medicine: Elebrato Ellipta | Updated |
06/05/2025 | Medicine: Obodence | Updated |
06/05/2025 | Medicine: Sunitinib Accord | Updated |
06/05/2025 | Medicine: Posaconazole Accord | Updated |
06/05/2025 | Document: UPD registration guide for UI and API users | Updated |
06/05/2025 | Medicine: Iqirvo | Updated |
06/05/2025 | Medicine: Imatinib Accord | Updated |
06/05/2025 | Medicine: Abiraterone Accord | Updated |
06/05/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – April 2025 | Updated |
06/05/2025 | Document: Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (April 2025) | New |
06/05/2025 | Medicine: Mayzent | Updated |
06/05/2025 | Medicine: Arsenic trioxide Mylan | Updated |
06/05/2025 | Document: Agenda of the PRAC meeting 5-8 May 2025 | New |
06/05/2025 | Document: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 - track changes | Updated |
06/05/2025 | Document: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 | Updated |
05/05/2025 | Medicine: Spikevax (previously COVID-19 Vaccine Moderna) | Updated |
05/05/2025 | Medicine: HyQvia | Updated |
05/05/2025 | Medicine: Trelegy Ellipta | Updated |
05/05/2025 | Medicine: Ketoconazole Esteve (previously Ketoconazole HRA) | Updated |
05/05/2025 | Medicine: Leqembi | Updated |
05/05/2025 | Medicine: Circadin | Updated |
05/05/2025 | Medicine: Kavigale | Updated |
05/05/2025 | Document: List of signals discussed at PRAC since September 2012 | Updated |
05/05/2025 | EU-M4all: Mosquirix - opinion on medicine for use outside EU | Updated |
05/05/2025 | Medicine: Hetronifly | Updated |
05/05/2025 | Medicine: Deltyba | Updated |
05/05/2025 | Medicine: mResvia | Updated |
05/05/2025 | Document: European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 5 | New |
05/05/2025 | Event: CVMP Interested Parties’ meeting May 2025 | New |
05/05/2025 | Medicine: Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan) | Updated |
05/05/2025 | Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 April 2025 PRAC | New |
05/05/2025 | Document: PRAC recommendations on signals adopted at the 7-10 April 2025 meeting | New |
05/05/2025 | Medicine: Ecansya (previously Capecitabine Krka) | Updated |
05/05/2025 | Medicine: Stoboclo | Updated |
05/05/2025 | Medicine: Capecitabine Accord | Updated |
02/05/2025 | Medicine: NeoRecormon | Updated |
02/05/2025 | Medicine: Nuvaxovid | Updated |
02/05/2025 | Page: Emergency Task Force (ETF) documents | Updated |
02/05/2025 | Document: PRAC-ETF considerations on the use of Ixchiq live attenuated virus vaccine against chikungunya | New |
02/05/2025 | Document: Organisation chart: Advisory functions | Updated |
02/05/2025 | Medicine: Capecitabine Medac | Updated |
02/05/2025 | Medicine: Xeloda | Updated |
02/05/2025 | Medicine: Zoledronic Acid Accord | Updated |
02/05/2025 | Medicine: Eptifibatide Accord | Updated |
02/05/2025 | Medicine: Levetiracetam Sun | Updated |
02/05/2025 | Medicine: Fintepla | Updated |
02/05/2025 | Medicine: Beyfortus | Updated |
02/05/2025 | Medicine: Bekemv | Updated |
02/05/2025 | Document: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA) | Updated |
02/05/2025 | Medicine: Alprolix | Updated |
02/05/2025 | Medicine: Pirsue | Updated |
02/05/2025 | Medicine: Segluromet | Updated |
02/05/2025 | Document: Agenda of the HMPC meeting 5-7 May 2025 | New |
02/05/2025 | Medicine: Lyrica | Updated |
02/05/2025 | Medicine: Lynozyfic | Updated |
02/05/2025 | Medicine: Piqray | Updated |
02/05/2025 | Medicine: Deferasirox Mylan | Updated |
02/05/2025 | Medicine: Opdivo | Updated |
02/05/2025 | Page: Handling competing interests | Updated |
02/05/2025 | Page: Data protection and privacy at EMA | Updated |
02/05/2025 | Page: Advisory functions | Updated |
02/05/2025 | Page: Regulatory acceptance of new approach methodologies (NAMs) to reduce animal use testing | New |
02/05/2025 | Page: SME Regulation and reports | Updated |
02/05/2025 | Document: Small and medium-sized enterprise (SME) office annual report 2024 | New |
01/05/2025 | Document: Policy 58: European Medicines Agency policy on the handling of competing interests of Management Board members | Updated |
01/05/2025 | Document: Policy 44: European Medicines Agency policy on the handling of competing interests of scientific committees’ members and experts | Updated |