Minutes of the HMPC meeting 5-7 May 2025
Submitted by Anonymous (not verified) on 9 July 2025 - 15:30
Minutes of the HMPC meeting 5-7 May 2025
Human medicines European public assessment report (EPAR): Braftovi, encorafenib, Date of authorisation: 19/09/2018, Revision: 16, Status: Authorised
Submitted by Anonymous (not verified) on 9 July 2025 - 15:22
Human medicines European public assessment report (EPAR): Braftovi, encorafenib, Date of authorisation: 19/09/2018, Revision: 16, Status: Authorised
Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, (Multi trial) substantial modification, non-substantial modification, and Request for information (RFI)
Submitted by Anonymous (not verified) on 9 July 2025 - 14:51
Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, (Multi trial) substantial modification, non-substantial modification, and Request for information (RFI)
Opinion on medicine for use outside EU: Dengue Tetravalent Vaccine (Live, Attenuated) Takeda, Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated,Dengue virus, serotype 2, expressing Dengue virus, serotype 3,
Submitted by Anonymous (not verified) on 9 July 2025 - 12:48
Opinion on medicine for use outside EU: Dengue Tetravalent Vaccine (Live, Attenuated) Takeda, Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated,Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated,Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated,Dengue virus, serotype 2, live, attenuated, Dengue, 13/10/2022 Positive opinion
14th industry stakeholder platform on research and development support, European Medicines Agency, Amsterdam, the Netherlands, from 3 July 2025, 12:30 (CEST) to 3 July 2025, 17:30 (CEST)
Submitted by Anonymous (not verified) on 9 July 2025 - 12:43
14th industry stakeholder platform on research and development support, European Medicines Agency, Amsterdam, the Netherlands, from 3 July 2025, 12:30 (CEST) to 3 July 2025, 17:30 (CEST)
Clinical Trial Information System (CTIS) - Sponsor handbook
Submitted by Anonymous (not verified) on 9 July 2025 - 12:20
Clinical Trial Information System (CTIS) - Sponsor handbook
Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 1 July 2025, 10:00 (CEST) to 1 July 2025, 11:30 (CEST)
Submitted by Anonymous (not verified) on 9 July 2025 - 9:42
Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 1 July 2025, 10:00 (CEST) to 1 July 2025, 11:30 (CEST)
Human medicines European public assessment report (EPAR): Ituxredi, rituximab, Date of authorisation: 19/09/2024, Revision: 1, Status: Authorised
Submitted by Anonymous (not verified) on 9 July 2025 - 9:10
Human medicines European public assessment report (EPAR): Ituxredi, rituximab, Date of authorisation: 19/09/2024, Revision: 1, Status: Authorised
Clinical Trials Information System (CTIS): online training modules for authorities
Submitted by Anonymous (not verified) on 9 July 2025 - 8:30
Clinical Trials Information System (CTIS): online training modules for authorities
Clinical Trials Information System (CTIS): training and support
Submitted by Anonymous (not verified) on 9 July 2025 - 8:30
Clinical Trials Information System (CTIS): training and support