Article 57 product data
Article 57 product data
Article 57 product data
Human medicines European public assessment report (EPAR): Norvir, ritonavir, Date of authorisation: 25/08/1996, Revision: 70, Status: Authorised
Human medicines European public assessment report (EPAR): Defitelio, defibrotide, Date of authorisation: 18/10/2013, Revision: 16, Status: Authorised
CHMP work plan 2024
Letter of support for a composite endpoint method for acceptability evaluation of oral drug formulations in the paediatric population
Paediatric investigation plans: submitting documents
Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes
Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
CHMP PROM minutes for the meeting on 30 October 2023
International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)