Human medicines European public assessment report (EPAR): INOmax, nitric oxide, Date of authorisation: 01/08/2001, Revision: 25, Status: Authorised

Appendix 1: Acceptable intakes established for N-nitrosamines

Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ - Version 1.5

External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.5

Human medicines European public assessment report (EPAR): Riluzole Zentiva, riluzole, Date of authorisation: 07/05/2012, Revision: 14, Status: Authorised

Annex - National provisions for SMEs applicable to the pharmaceutical sector

Human medicines European public assessment report (EPAR): Rytelo, imetelstat, Date of authorisation: 07/03/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Dimethyl fumarate Mylan, dimethyl fumarate, Date of authorisation: 22/04/2024, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Faslodex, fulvestrant, Date of authorisation: 09/03/2004, Revision: 26, Status: Authorised

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - July 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 22 July 2025, 11:00 (CEST) to 22 July 2025, 12:00 (CEST)