Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA Workshop: Event agenda

Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for Identification of Medicinal Products (IDMP) in Europe: Registration requirements to public PMS API (beta release) - Chapter 1, Annex B

Product Management Service (PMS) User Acceptance Testing (UAT) Application Programming Interface (API) registration process for industry - Chapter 1, Annex A

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 for production environments

Substance and product data management services

Human medicines European public assessment report (EPAR): Amlodipine / Valsartan Mylan, amlodipine,valsartan, Date of authorisation: 22/03/2016, Revision: 18, Status: Authorised

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026

Human medicines European public assessment report (EPAR): Fingolimod Mylan, fingolimod, Date of authorisation: 18/08/2021, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Deferasirox Mylan, deferasirox, Date of authorisation: 26/09/2019, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Azacitidine Mylan, azacitidine, Date of authorisation: 27/03/2020, Revision: 2, Status: Authorised