Meeting Summary - Medicine Shortages SPOC Working Party 14-15 October 2025
Submitted by Anonymous (not verified) on 28 November 2025 - 14:14
Meeting Summary - Medicine Shortages SPOC Working Party 14-15 October 2025
Human medicines European public assessment report (EPAR): Kyprolis, carfilzomib, Date of authorisation: 19/11/2015, Revision: 21, Status: Authorised
Submitted by Anonymous (not verified) on 28 November 2025 - 14:14
Human medicines European public assessment report (EPAR): Kyprolis, carfilzomib, Date of authorisation: 19/11/2015, Revision: 21, Status: Authorised
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 November 2025
Submitted by Anonymous (not verified) on 28 November 2025 - 11:00
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 November 2025
Kick-off meeting of the HMA-EMA group focused on AI with industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 7 November 2025, 09:00 (CET) to 7 November 2025, 10:30 (CET)
Submitted by Anonymous (not verified) on 28 November 2025 - 10:40
Kick-off meeting of the HMA-EMA group focused on AI with industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 7 November 2025, 09:00 (CET) to 7 November 2025, 10:30 (CET)
Veterinary medicines European public assessment report (EPAR): Hemosyvet, etamsylate, Status: Authorised
Submitted by Anonymous (not verified) on 28 November 2025 - 10:08
Veterinary medicines European public assessment report (EPAR): Hemosyvet, etamsylate, Status: Authorised
PSUSA/00002203/202504
Submitted by Anonymous (not verified) on 28 November 2025 - 9:15
PSUSA/00002203/202504
List of centrally authorised products with safety-related changes to the product information
Submitted by Anonymous (not verified) on 28 November 2025 - 9:10
List of centrally authorised products with safety-related changes to the product information
PSUSA/00010377/202504
Submitted by Anonymous (not verified) on 28 November 2025 - 9:10
PSUSA/00010377/202504
Human medicines European public assessment report (EPAR): Atropine sulfate FGK, atropine, Date of refusal: 21/11/2025, Status: Refused
Submitted by Anonymous (not verified) on 28 November 2025 - 9:00
Human medicines European public assessment report (EPAR): Atropine sulfate FGK, atropine, Date of refusal: 21/11/2025, Status: Refused
Human medicines European public assessment report (EPAR): Byfavo, remimazolam, Date of authorisation: 26/03/2021, Revision: 9, Status: Authorised
Submitted by Anonymous (not verified) on 28 November 2025 - 8:45
Human medicines European public assessment report (EPAR): Byfavo, remimazolam, Date of authorisation: 26/03/2021, Revision: 9, Status: Authorised