Business process description for committee management
Submitted by Anonymous (not verified) on 22 April 2025 - 15:07
Business process description for committee management
Template for late submission of ICSRs to EV
Submitted by Anonymous (not verified) on 22 April 2025 - 14:48
Template for late submission of ICSRs to EV
European Medicines Agency’s data protection notice for EudraVigilance Human (EV)
Submitted by Anonymous (not verified) on 22 April 2025 - 14:40
European Medicines Agency’s data protection notice for EudraVigilance Human (EV)
Qualification opinion for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology in liver biopsies to determine disease activity in NASH/MASH clinical trials
Submitted by Anonymous (not verified) on 22 April 2025 - 14:03
Qualification opinion for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology in liver biopsies to determine disease activity in NASH/MASH clinical trials
Human medicines European public assessment report (EPAR): Retacrit, epoetin zeta, Date of authorisation: 18/12/2007, Revision: 32, Status: Authorised
Submitted by Anonymous (not verified) on 22 April 2025 - 12:55
Human medicines European public assessment report (EPAR): Retacrit, epoetin zeta, Date of authorisation: 18/12/2007, Revision: 32, Status: Authorised
PSUSA/00002774/202408
Submitted by Anonymous (not verified) on 16 April 2025 - 16:15
PSUSA/00002774/202408
PSUSA/00000027/202407
Submitted by Anonymous (not verified) on 16 April 2025 - 16:14
PSUSA/00000027/202407
Human medicines European public assessment report (EPAR): Pirfenidone Viatris, pirfenidone, Date of authorisation: 10/01/2023, Revision: 3, Status: Authorised
Submitted by Anonymous (not verified) on 16 April 2025 - 15:36
Human medicines European public assessment report (EPAR): Pirfenidone Viatris, pirfenidone, Date of authorisation: 10/01/2023, Revision: 3, Status: Authorised
Variations requiring assessment (veterinary medicines)
Submitted by Anonymous (not verified) on 16 April 2025 - 15:35
Variations requiring assessment (veterinary medicines)
Human medicines European public assessment report (EPAR): Epysqli, Date of authorisation: 26/05/2023, Revision: 3, Status: Authorised
Submitted by Anonymous (not verified) on 16 April 2025 - 15:32
Human medicines European public assessment report (EPAR): Epysqli, Date of authorisation: 26/05/2023, Revision: 3, Status: Authorised