ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Step 5
Committee for Orphan Medicinal Products (COMP): 3-5 October 2023, European Medicines Agency, Amsterdam, the Netherlands, 3 October 2023
List of medicines currently in PRIME scheme
Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 11-14 December 2023
Development and manufacture of human medicinal products specifically designed for phage therapy - Scientific guideline
Human medicines European public assessment report (EPAR): Dimethyl fumarate Teva, dimethyl fumarate, Date of authorisation: 12/12/2022, Date of refusal: 12/12/2023, Status: Withdrawn
Follow-up reply to Members of the European Parliament regarding mRNA COVID-19 vaccines
Human medicines European public assessment report (EPAR): Dimethyl fumarate Polpharma, dimethyl fumarate, Date of authorisation: 13/05/2022, Revision: 5, Status: Withdrawn
Vaxzevria: Periodic safety update report assessment 29 June 2022 to 28 December 2022
Spikevax : Periodic safety update report assessment 19 June 2022 to 17 December 2022