European Medicines Agency approvals of new medicines in November and December 2025

The Lancet Regional Health - Europe 2026 Open access

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Authors: Bruno Miguel Nogueira Sepodes, Juan García Burgos, Steffen Thirstrup
DOI: 10.1016/j.lanepe.2025.101582
Cited by: 1
References: 4

Abstract

In November and December 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the granting of an EU-wide authorisation for 11 new medicines (Table 1) and 4 new biosimilar medicines (Table 2). The CHMP also recommended the authorisation of 2 new generic medicines and new indications for 16 medicines already authorised in the EU.1,2

Fields of Study & Subjects

Chemical Reactions and Isotopes Pharmaceutical Economics and Policy Pharmaceutical Quality and Counterfeiting

Publication details

Journal / source
The Lancet Regional Health - Europe
Publisher
Elsevier BV
Volume
61
Pages
101582–101582
Publication date
8 January 2026
Language
EN