Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023
Referral: Hydroxyprogesterone-containing medicinal products, hydroxyprogesterone, associated names: Lentogest,Progesterone Retard Pharlon,Proluton Depot, Article 31 referrals, Procedure started, 29/09/2023
Template: Declaration for the risk management plan (RMP) publication
Template for submission of comments for the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet)
Call for comments on the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet)
Combined VeDDRA list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products
Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use, European Medicines Agency and online, from 26/06/2023 to 27/06/2023
Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms
Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products
Mefloquine : List of nationally authorised medicinal products - PSUSA/00001955/202302