Network Portfolio Roadmap 2023-2025

List of industry subject matter experts and list of planned calls for industry subject matter experts

Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies

Report on the implementation of the EMA-EUnetHTA 21 work plan 2021 - 2023

Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Votubia (everolimus) for the treatment of tuberous sclerosis

Management Board meeting: 7-8 June 2023, European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2023 to 08/06/2023

Human medicines European public assessment report (EPAR): Pelgraz, pegfilgrastim, Neutropenia, Date of authorisation: 21/09/2018, Revision: 11, Status: Authorised

Orphan designation: N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt, Treatment of acute myeloid leukaemia, 23/03/2009, Positive

Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5-dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]carbonyl]-2-methylalanyl-teriparatide (2:1), Treatment of hypoparathyroidism, 19/10/2020, Positive

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2023