Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 August 2023
Tetanus vaccines : List of nationally authorised medicinal products - PSUSA/00002910/202301
Cefprozil : List of nationally authorised medicinal products - PSUSA/00000605/202212
Human medicines European public assessment report (EPAR): Tafinlar, dabrafenib, Melanoma, Date of authorisation: 26/08/2013, Revision: 29, Status: Authorised
Allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L.(sublingual tablet) : List of nationally authorised medicinal products - PSUSA/00010465/202212
Opinion/decision on a Paediatric investigation plan (PIP): Axumin,Fluciclovine (18F), decision type: , therapeutic area: , PIP number: P/0335/2022
European Medicines Agency’s Data Protection Notice for the user test of the Critical Medical Device Shortages (CMDS) system
Codeine camphosulphonate / sodium benzoate, codeine camphosulphonate / sulfogaiacol / grindelia soft extract : List of nationally authorised medicinal products - PSUSA/00010542/202212
Atracurium : List of nationally authorised medicinal products - PSUSA/00000267/202212
Hypericum perforatum L., herba : List of nationally authorised medicinal products - PSUSA/00001701/202301