Annex 10 - 2023 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication
2023 annual report of the European Medicines Agency
ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2b
Referral: Procaine benzylpenicillin Article 82 European Commission final decision, 07/09/2023, 11/12/2023, 29/05/2024
Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level
Human medicines European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira), voriconazole, Date of authorisation: 27/05/2015, Revision: 13, Status: Authorised
Annex XV - List of topiramate containing medicinal products in the European Union
Annex XV - List of topiramate containing medicinal products in the European Union
List of medicinal products under additional monitoring
List of medicinal products under additional monitoring