PSUSA/00002737/202501
Submitted by Anonymous (not verified) on 23 October 2025 - 12:57
PSUSA/00002737/202501
Overview of (invented) names reviewed in September 2025 by the Name Review Group (NRG) adopted at the CHMP meeting of 16 October 2025
Submitted by Anonymous (not verified) on 23 October 2025 - 12:55
Overview of (invented) names reviewed in September 2025 by the Name Review Group (NRG) adopted at the CHMP meeting of 16 October 2025
Orphan designation: recombinant human N-acetylgalactosamine-6-sulfatase (elosulfase alfa) Treatment of mucopolysaccharidosis, type IVA (Morquio A syndrome), 24/07/2009 Withdrawn
Submitted by Anonymous (not verified) on 23 October 2025 - 12:51
Orphan designation: recombinant human N-acetylgalactosamine-6-sulfatase (elosulfase alfa) Treatment of mucopolysaccharidosis, type IVA (Morquio A syndrome), 24/07/2009 Withdrawn
Human medicines European public assessment report (EPAR): Vimizim, elosulfase alfa, Date of authorisation: 27/04/2014, Revision: 13, Status: Authorised
Submitted by Anonymous (not verified) on 23 October 2025 - 12:50
Human medicines European public assessment report (EPAR): Vimizim, elosulfase alfa, Date of authorisation: 27/04/2014, Revision: 13, Status: Authorised
Human medicines European public assessment report (EPAR): Camzyos, mavacamten, Date of authorisation: 26/06/2023, Revision: 6, Status: Authorised
Submitted by Anonymous (not verified) on 23 October 2025 - 9:30
Human medicines European public assessment report (EPAR): Camzyos, mavacamten, Date of authorisation: 26/06/2023, Revision: 6, Status: Authorised
Opinion/decision on a Paediatric investigation plan (PIP): Volibris, ambrisentan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Respiratory, thoracic and mediastinal disorders, PIP number: P/0384/2024
Submitted by Anonymous (not verified) on 23 October 2025 - 9:21
Opinion/decision on a Paediatric investigation plan (PIP): Volibris, ambrisentan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Respiratory, thoracic and mediastinal disorders, PIP number: P/0384/2024
EMA/PE/0000221282
Submitted by Anonymous (not verified) on 23 October 2025 - 9:11
EMA/PE/0000221282
EMA/PE/0000181891
Submitted by Anonymous (not verified) on 23 October 2025 - 8:42
EMA/PE/0000181891
EMA/PE/0000225106
Submitted by Anonymous (not verified) on 23 October 2025 - 8:37
EMA/PE/0000225106
10 EFIM Day
Submitted by Aneta on 22 October 2025 - 19:37
The 10th EFIM Day took place on Friday, 17 October 2025, marking a decade of EFIM Days gathering EFIM national societies leadership, representatives, and invited guests.
We had the pleasure to celebrate 10 years of sharing knowledge and European insight with participants presenting 25 EFIM national societies members at the Crown Plaza Brussels Airport hotel.
The 10th EFIM Day opened with a presentation by Prof. George Dalekos, EFIM President, who provided a comprehensive overview of EFIM’s activities and achievements since March 2025 following the congress in Florence.