Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements

Data access to medicinal products for human use - Chapter 5 Annex A: Product data elements accessible by stakeholder group

Fourth European Medicines Agency (EMA)-Vaccines Europe bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 14 October 2025

Human medicines European public assessment report (EPAR): Pazenir, paclitaxel, Date of authorisation: 06/05/2019, Revision: 10, Status: Authorised

Herbal medicinal product: Zingiberis rhizoma, Zingiber officinale Roscoe, F: Assessment finalised

Human medicines European public assessment report (EPAR): Zelboraf, vemurafenib, Date of authorisation: 17/02/2012, Revision: 26, Status: Authorised

Outcome of written procedures finalised during the period from 4 March 2025 to 28 May 2025

Human medicines European public assessment report (EPAR): Jetrea, ocriplasmin, Date of authorisation: 13/03/2013, Revision: 15, Status: Withdrawn

Human medicines European public assessment report (EPAR): Aquipta, atogepant, Date of authorisation: 11/08/2023, Revision: 4, Status: Authorised

New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 April 2025 PRAC