Biosimilar medicines: Overview
Submitted by Anonymous (not verified) on 2 April 2025 - 11:16
Biosimilar medicines: Overview
Tolvaptan product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 2 April 2025 - 10:38
Tolvaptan product-specific bioequivalence guidance
EMEA-000551-PIP04-21-M03
Submitted by Anonymous (not verified) on 2 April 2025 - 10:31
EMEA-000551-PIP04-21-M03
Opinion/decision on a Paediatric investigation plan (PIP): Quviviq, Daridorexant, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0054/2024
Submitted by Anonymous (not verified) on 2 April 2025 - 10:23
Opinion/decision on a Paediatric investigation plan (PIP): Quviviq, Daridorexant, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0054/2024
Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan medoxomil, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vascular disorders, PIP number: P/0053/2024
Submitted by Anonymous (not verified) on 2 April 2025 - 10:01
Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan medoxomil, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vascular disorders, PIP number: P/0053/2024
EMEA-002234-PIP01-17-M02
Submitted by Anonymous (not verified) on 2 April 2025 - 9:21
EMEA-002234-PIP01-17-M02
Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP)
Submitted by Anonymous (not verified) on 2 April 2025 - 9:17
Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP)
Mandate, objectives and composition of the Patients and Consumers Working Party (PCWP)
Submitted by Anonymous (not verified) on 2 April 2025 - 9:14
Mandate, objectives and composition of the Patients and Consumers Working Party (PCWP)
Mandate, objectives and composition of the Healthcare Professionals Working Party (HCPWP)
Submitted by Anonymous (not verified) on 2 April 2025 - 9:12
Mandate, objectives and composition of the Healthcare Professionals Working Party (HCPWP)
Fourth listen-and-learn focus group meeting of the Quality Innovation Group, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 November 2024 to 20 November 2024
Submitted by Anonymous (not verified) on 2 April 2025 - 8:49
Fourth listen-and-learn focus group meeting of the Quality Innovation Group, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 November 2024 to 20 November 2024