EMEA-002734-PIP01-19-M01

Opinion/decision on a Paediatric investigation plan (PIP): Exparel liposomal, bupivacaine, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pain, PIP number: P/0021/2024

Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0037/2024

Human medicines European public assessment report (EPAR): Xeljanz, tofacitinib, Date of authorisation: 22/03/2017, Date of refusal: 25/04/2013, Revision: 34, Status: Authorised

Human medicines European public assessment report (EPAR): Seladelpar Gilead, Seladelpar lysine dihydrate, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Siiltibcy, Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10), Date of authorisation: 13/01/2025, Revision: 1, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Blincyto, blinatumomab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Blood and lymphatic system disorders, PIP number: P/0040/2024

PhV non-compliance notification contact points at National Competent Authority (NCA) level

EMA establishes regular procedure for scientific advice on certain high-risk medical devices

Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 March 2025, 11:30 (CET) to 13 March 2025, 12:00 (CET)