Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)
Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)
Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)
Work plan for the Committee for Veterinary Medicinal Products (CVMP) Immunologicals Working Party (IWP) 2026
Work plan for the Committee for Veterinary Medicinal Products (CVMP) Scientific Advice Working Party (SAWP-V) for 2026
Stability testing for applications for variations to marketing authorisation - Scientific guideline
Guideline on stability testing for applications for variations to a marketing authorisation - Revision 3
Human medicines European public assessment report (EPAR): Teriflunomide Viatris (previously Teriflunomide Mylan), teriflunomide, Date of authorisation: 09/11/2022, Revision: 6, Status: Authorised
Human medicines European public assessment report (EPAR): Darunavir Viatris (previously Darunavir Mylan), darunavir, Date of authorisation: 03/01/2017, Revision: 17, Status: Authorised
Human medicines European public assessment report (EPAR): Tobi Podhaler, tobramycin, Date of authorisation: 20/07/2011, Revision: 24, Status: Authorised
Human medicines European public assessment report (EPAR): Afstyla, lonoctocog alfa, Date of authorisation: 04/01/2017, Revision: 12, Status: Authorised
Highlights - 20th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation meeting