Paediatric Committee (PDCO): 15-18 October 2024, European Medicines Agency, Amsterdam, the Netherlands, from 15 October 2024 to 18 October 2024
Minutes - PDCO minutes of the 15-18 October 2024 meeting
PSUSA/00001075/202404
PSUSA/00000717/202403
Human medicines European public assessment report (EPAR): Lutetium (177Lu) chloride Billev (previously Illuzyce), lutetium (177Lu) chloride, Date of authorisation: 15/09/2022, Revision: 3, Status: Authorised
Human medicines European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde), irinotecan hydrochloride trihydrate, Date of authorisation: 14/10/2016, Revision: 14, Status: Authorised
Human medicines European public assessment report (EPAR): Akantior, polihexanide, Date of authorisation: 22/08/2024, Status: Authorised
Draft of Data Quality Framework for EU medicines regulation application to real-world data
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024
Dexketoprofen / tramadol - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00010468/202201