Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 13 May 2025, 09:30 (CEST) to 13 May 2025, 13:00 (CEST)

Meeting summary of the Medicine Shortages SPOC Working Party meeting on 13 May 2025

Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, Benralizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Blood and lymphatic system disorders, PIP number: P/0307/2024

Opinion/decision on a Paediatric investigation plan (PIP): Rydapt, Midostaurin, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0305/2024

EMEA-000205-PIP02-11-M07

SME Regulation and reports

Human medicines European public assessment report (EPAR): Hyftor, sirolimus, Date of authorisation: 15/05/2023, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Rilonacept FGK Representative Service GmbH , rilonacept, Status: Application withdrawn

Procedural guidance to scientific committeesꞌ members and experts on completing the European Medicines Agencyꞌs declaration of interests in the Experts Management Tool

Minutes of the PRAC meeting 5-8 May 2025