Orphan designation: navitoclax Treatment of myelofibrosis, 16/12/2019 Withdrawn
Submitted by Anonymous (not verified) on 26 May 2026 - 10:39
Orphan designation: navitoclax Treatment of myelofibrosis, 16/12/2019 Withdrawn
Orphan designation: acalabrutinib Treatment of mantle cell lymphoma, 21/03/2016 Withdrawn
Submitted by Anonymous (not verified) on 26 May 2026 - 10:35
Orphan designation: acalabrutinib Treatment of mantle cell lymphoma, 21/03/2016 Withdrawn
Orphan designation: pegylated adrenomedullin Treatment of acute respiratory distress syndrome (ARDS), 27/07/2020 Withdrawn
Submitted by Anonymous (not verified) on 26 May 2026 - 10:35
Orphan designation: pegylated adrenomedullin Treatment of acute respiratory distress syndrome (ARDS), 27/07/2020 Withdrawn
Second HMA/EMA multi-stakeholder forum on EudraVigilance and signal detection, Online, European Medicines Agency, Amsterdam, the Netherlands, 1 December 2026
Submitted by Anonymous (not verified) on 26 May 2026 - 9:21
Second HMA/EMA multi-stakeholder forum on EudraVigilance and signal detection, Online, European Medicines Agency, Amsterdam, the Netherlands, 1 December 2026
Network Portfolio Roadmap
Submitted by Anonymous (not verified) on 26 May 2026 - 8:27
Network Portfolio Roadmap
Human medicines European public assessment report (EPAR): Ucedane, carglumic acid, Date of authorisation: 23/06/2017, Revision: 14, Status: Authorised
Submitted by Anonymous (not verified) on 26 May 2026 - 8:19
Human medicines European public assessment report (EPAR): Ucedane, carglumic acid, Date of authorisation: 23/06/2017, Revision: 14, Status: Authorised
Questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document for assessors
Submitted by Anonymous (not verified) on 22 May 2026 - 15:00
Questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document for assessors
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
Submitted by Anonymous (not verified) on 22 May 2026 - 14:40
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
Human medicines European public assessment report (EPAR): Adempas, riociguat, Date of authorisation: 27/03/2014, Revision: 18, Status: Authorised
Submitted by Anonymous (not verified) on 22 May 2026 - 14:25
Human medicines European public assessment report (EPAR): Adempas, riociguat, Date of authorisation: 27/03/2014, Revision: 18, Status: Authorised
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 19-21 May 2026
Submitted by Anonymous (not verified) on 22 May 2026 - 14:12
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 19-21 May 2026