New fee regulation: General questions and answers - Annex III

New fee regulation: General questions and answers - Annex II

Human medicines European public assessment report (EPAR): Pombiliti, cipaglucosidase alfa, Date of authorisation: 20/03/2023, Revision: 1, Status: Authorised

Meeting Summary of the Medicine Shortages (SPOC) Working Party meeting 7-8 October 2024

Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products

QRD statements for metered dose inhalers containing fluorinated greenhouse gases

Opinion/decision on a Paediatric investigation plan (PIP): Uptravi, Selexipag, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0417/2023

Opinion/decision on a Paediatric investigation plan (PIP): Giapreza, Angiotensin II (LJPC-501), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiovascular diseases, PIP number: P/0415/2023

Opinion/decision on a Paediatric investigation plan (PIP): Veyvondi, vonicog alfa, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: P/0416/2023

Opinion/decision on a Paediatric investigation plan (PIP): Libtayo, Cemiplimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0414/2023