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Last updated about 16 hours ago
Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Date of authorisation: 01/07/2013, Revision: 30, Status: Authorised
about 16 hours ago
Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Date of authorisation...
Sponsor guidance: New safety module on the annual safety report
about 16 hours ago
Sponsor guidance: New safety module on the annual safety report
Human medicines European public assessment report (EPAR): Qoyvolma, ustekinumab, Date of authorisation: 02/06/2025, Revision: 4, Status: Withdrawn
about 17 hours ago
Human medicines European public assessment report (EPAR): Qoyvolma, ustekinumab, Date of authorisation...
Fifth European Medicines Agency and Nuclear Medicines Europe bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, 10 July 2026
about 18 hours ago
Fifth European Medicines Agency and Nuclear Medicines Europe bilateral meeting, Online, European...
18th Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 21 September 2026, 09:00 (CEST) to 21 September 2026, 12:30 (CEST)
about 18 hours ago
18th Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the...
Human medicines European public assessment report (EPAR): Privigen, human normal immunoglobulin (IVIg), Date of authorisation: 24/04/2008, Revision: 34, Status: Authorised
2 days ago
Human medicines European public assessment report (EPAR): Privigen, human normal immunoglobulin (IVIg)...
First European Medicines Agency (EMA) and Active Pharmaceutical Ingredients Committee (APIC) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 2 September 2026, 15:30 (CEST) to 2 September 2026, 17:30 (CEST)
about 20 hours ago
First European Medicines Agency (EMA) and Active Pharmaceutical Ingredients Committee (APIC) bilateral...
List of centrally authorised products with safety-related changes to the product information
2 days ago
List of centrally authorised products with safety-related changes to the product information
Human medicines European public assessment report (EPAR): Multaq, dronedarone, Date of authorisation: 25/11/2009, Revision: 23, Status: Authorised
about 22 hours ago
Human medicines European public assessment report (EPAR): Multaq, dronedarone, Date of authorisation...
Human medicines European public assessment report (EPAR): Kaftrio, ivacaftor,tezacaftor,elexacaftor, Date of authorisation: 21/08/2020, Revision: 33, Status: Authorised
about 22 hours ago
Human medicines European public assessment report (EPAR): Kaftrio, ivacaftor,tezacaftor,elexacaftor, Date of authorisation...
Human medicines European public assessment report (EPAR): Aspaveli, pegcetacoplan, Date of authorisation: 13/12/2021, Revision: 14, Status: Authorised
about 22 hours ago
Human medicines European public assessment report (EPAR): Aspaveli, pegcetacoplan, Date of authorisation...
Start of procedure: Extension of marketing authorisation (26 June 2026 - 23 July 2026)
about 23 hours ago
Start of procedure: Extension of marketing authorisation (26 June 2026 - 23...