European Medicines Agency approvals of new medicines in September and October 2026

In September and October 2026, 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 3 new generic medicines and new indications for 16 medicines already authorised in the EU.1,2

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Journal
The Lancet Regional Health - Europe
Published
2026-11-09
DOI
https://doi.org/10.1016/j.lanepe.2026.101920
Primary Topic
Pharmaceutical Economics and Policy
Type
article
Field-Weighted Citation Impact
0.00
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article

European Medicines Agency approvals of new medicines in September and October 2026

Steffen Thirstrup, Juan García Burgos, Bruno Miguel Nogueira Sepodes
The Lancet Regional Health - Europe
Pharmaceutical Economics and Policy
article

European Medicines Agency approvals of new medicines in September and October 2026

Steffen Thirstrup, Juan García Burgos, Bruno Miguel Nogueira Sepodes
article en

Abstract

In September and October 2026, 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 3 new generic medicines and new indications for 16 medicines already authorised in the EU.1,2

The Lancet Regional Health - EuropeVol. 71
European Medicines Agency (NL), University of Lisbon (PT)
Pharmaceutical Economics and Policy
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