Nitrosamine impurities
Submitted by Anonymous (not verified) on 29 July 2025 - 8:35
Nitrosamine impurities
Report: European medicines regulatory network’s response to nitrosamine impurities in human medicines
Submitted by Anonymous (not verified) on 29 July 2025 - 8:33
Report: European medicines regulatory network’s response to nitrosamine impurities in human medicines
Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (20 June 2025 - 24 July 2025)
Submitted by Anonymous (not verified) on 28 July 2025 - 15:12
Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (20 June 2025 - 24 July 2025)
Start of procedure: Extension of marketing authorisation (20 June 2025 - 24 July 2025)
Submitted by Anonymous (not verified) on 28 July 2025 - 15:09
Start of procedure: Extension of marketing authorisation (20 June 2025 - 24 July 2025)
SPOR and XEVMPD status update webinar, Broadcast, from 9 July 2025, 10:00 (CEST) to 9 July 2025, 12:30 (CEST)
Submitted by Anonymous (not verified) on 28 July 2025 - 13:47
SPOR and XEVMPD status update webinar, Broadcast, from 9 July 2025, 10:00 (CEST) to 9 July 2025, 12:30 (CEST)
Questions & Answers extract - SPOR and XEVMPD status update webinar 9 July 2025
Submitted by Anonymous (not verified) on 28 July 2025 - 13:45
Questions & Answers extract - SPOR and XEVMPD status update webinar 9 July 2025
Procurement
Submitted by Anonymous (not verified) on 28 July 2025 - 13:07
Procurement
Additional information - Applicant’s clarifications following Paediatric Committee (PDCO) discussions or re-discussions
Submitted by Anonymous (not verified) on 28 July 2025 - 12:40
Additional information - Applicant’s clarifications following Paediatric Committee (PDCO) discussions or re-discussions
Response to Paediatric Committee request for supplementary information and modification of proposed PIP (RSI) - Re-submission following clock-stop
Submitted by Anonymous (not verified) on 28 July 2025 - 12:40
Response to Paediatric Committee request for supplementary information and modification of proposed PIP (RSI) - Re-submission following clock-stop
Key elements form: Applicant’s proposal for a paediatric-investigation-plan opinion
Submitted by Anonymous (not verified) on 28 July 2025 - 12:40
Key elements form: Applicant’s proposal for a paediatric-investigation-plan opinion