Human medicines European public assessment report (EPAR): Enwylma, denosumab, Date of authorisation: 26/06/2025, Revision: 1, Status: Authorised
Dear Colleagues,
On behalf of the Acute Medicine and Hospitalism EFIM Working Group, we are conducting a survey to better understand how Intermediate Care Units (IMCUs) are organised and integrated within acute and internal medicine services.
The aim of this initiative is to collect practical insights from national societies in order to:
Procedural advice on paediatric applications
Template for scientific document for paediatric investigation plan or product-specific waiver
Paediatric investigation plan (PIP) - Key elements form
PSUSA/00001392/202508
Opinion on medicine for use outside EU: Acoziborole Winthrop, acoziborole, Trypanosomiasis, African, 24/02/2026 Positive opinion
Human medicines European public assessment report (EPAR): Jelrix, autologous cartilage-derived articular chondrocytes, in-vitro expanded, Status: Application withdrawn
Human medicines European public assessment report (EPAR): Kygevvi, doxecitine,doxribtimine, Date of authorisation: 26/03/2026, Status: Authorised
Human medicines European public assessment report (EPAR): Teduglutide Viatris, teduglutide, Date of authorisation: 08/01/2026, Revision: 2, Status: Authorised