Outcome of written procedures finalised during the period from 04 March 2026 to 03 June 2026

Breakthrough medical devices: information session, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 April 2026, 15:00 (CEST) to 24 April 2026, 17:00 (CEST)

Human medicines European public assessment report (EPAR): Dazluma, troriluzole, Status: Application withdrawn

Human medicines European public assessment report (EPAR): Tecvayli, teclistamab, Date of authorisation: 23/08/2022, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Privigen, human normal immunoglobulin (IVIg), Date of authorisation: 24/04/2008, Revision: 33, Status: Authorised

ICH E22 General considerations for patient preference studies - Scientific guideline

Appendix 1: Acceptable intakes established for N-nitrosamines

Fee regulation working arrangements

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Human medicines European public assessment report (EPAR): Hemangiol, propranolol, Date of authorisation: 23/04/2014, Revision: 8, Status: Authorised