Guidance for industry on implementing Shortage Prevention Plans (SPP)
Submitted by Anonymous (not verified) on 31 August 2026 - 11:00
Guidance for industry on implementing Shortage Prevention Plans (SPP)
List of centrally authorised products with safety-related changes to the product information
Submitted by Anonymous (not verified) on 31 August 2026 - 9:16
List of centrally authorised products with safety-related changes to the product information
Innovation Task Force (ITF) briefing meeting request form
Submitted by Anonymous (not verified) on 28 August 2026 - 16:53
Innovation Task Force (ITF) briefing meeting request form
Human medicines European public assessment report (EPAR): Mounjaro, tirzepatide, Date of authorisation: 15/09/2022, Revision: 21, Status: Authorised
Submitted by Anonymous (not verified) on 28 August 2026 - 14:08
Human medicines European public assessment report (EPAR): Mounjaro, tirzepatide, Date of authorisation: 15/09/2022, Revision: 21, Status: Authorised
PSUSA/00001088/202512
Submitted by Anonymous (not verified) on 28 August 2026 - 13:40
PSUSA/00001088/202512
Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Date of authorisation: 09/02/2018, Revision: 26, Status: Authorised
Submitted by Anonymous (not verified) on 28 August 2026 - 13:30
Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Date of authorisation: 09/02/2018, Revision: 26, Status: Authorised
PSUSA/00000732/202512
Submitted by Anonymous (not verified) on 28 August 2026 - 13:21
PSUSA/00000732/202512
Electronic product information (ePI)
Submitted by Anonymous (not verified) on 28 August 2026 - 10:00
Electronic product information (ePI)
PSUSA/00011041/202510
Submitted by Anonymous (not verified) on 28 August 2026 - 9:49
PSUSA/00011041/202510
How to pay fees and charges levied by EMA: Guidance to marketing authorisation holders and applicants
Submitted by Anonymous (not verified) on 28 August 2026 - 9:36
How to pay fees and charges levied by EMA: Guidance to marketing authorisation holders and applicants