CHMP PROM minutes for the meeting on 15 April 2024
Submitted by Anonymous (not verified) on 19 July 2024 - 9:52
CHMP PROM minutes for the meeting on 15 April 2024
Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals
Submitted by Anonymous (not verified) on 19 July 2024 - 9:38
Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals
Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
Submitted by Anonymous (not verified) on 19 July 2024 - 8:10
Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
Human medicines European public assessment report (EPAR): Tenofovir disoproxil Mylan, tenofovir disoproxil, Date of authorisation: 08/12/2016, Revision: 19, Status: Authorised
Submitted by Anonymous (not verified) on 19 July 2024 - 7:25
Human medicines European public assessment report (EPAR): Tenofovir disoproxil Mylan, tenofovir disoproxil, Date of authorisation: 08/12/2016, Revision: 19, Status: Authorised
Opinion/decision on a Paediatric investigation plan (PIP): Veltassa, Patiromer calcium, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0106/2023
Submitted by Anonymous (not verified) on 18 July 2024 - 15:42
Opinion/decision on a Paediatric investigation plan (PIP): Veltassa, Patiromer calcium, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0106/2023
Human medicines European public assessment report (EPAR): Vantavo (previously Alendronate sodium and colecalciferol, MSD), alendronic acid,colecalciferol, Date of authorisation: 16/10/2009, Revision: 20, Status: Authorised
Submitted by Anonymous (not verified) on 18 July 2024 - 14:28
Human medicines European public assessment report (EPAR): Vantavo (previously Alendronate sodium and colecalciferol, MSD), alendronic acid,colecalciferol, Date of authorisation: 16/10/2009, Revision: 20, Status: Authorised
Withdrawn application: Adcetris, 23/02/2024
Submitted by Anonymous (not verified) on 18 July 2024 - 14:00
Withdrawn application: Adcetris, 23/02/2024
Quarterly System Demo – Q2 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 June 2024, 09:00 (CEST) to 26 June 2024, 13:30 (CEST)
Submitted by Anonymous (not verified) on 18 July 2024 - 13:02
Quarterly System Demo – Q2 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 June 2024, 09:00 (CEST) to 26 June 2024, 13:30 (CEST)
Q&A - Quarterly System Demo Q2 2024
Submitted by Anonymous (not verified) on 18 July 2024 - 13:01
Q&A - Quarterly System Demo Q2 2024
Human medicines European public assessment report (EPAR): Agilus, dantrolene sodium, hemiheptahydrate, Date of authorisation: 29/05/2024, Status: Authorised
Submitted by Anonymous (not verified) on 18 July 2024 - 10:26
Human medicines European public assessment report (EPAR): Agilus, dantrolene sodium, hemiheptahydrate, Date of authorisation: 29/05/2024, Status: Authorised