Human medicines European public assessment report (EPAR): Akantior, polihexanide, Date of authorisation: 22/08/2024, Status: Authorised

Draft of Data Quality Framework for EU medicines regulation application to real-world data

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024

Dexketoprofen / tramadol - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00010468/202201

ICH E6 (R2) Good clinical practice - Scientific guideline

Opinion of the CVMP on the establishment of maximum residue limits: Ketoprofen

Opinion of the CVMP on the establishment of maximum residue limits: Toltrazuril

Human medicines European public assessment report (EPAR): Duloxetine Zentiva, duloxetine, Date of authorisation: 20/08/2015, Revision: 13, Status: Authorised

PSUSA/00010488/202405

Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology;Immunology-Rheumatology-Transplantation, PIP number: P/0452/2023