EMA CHMP Meeting Highlights – 10-13 November 2025

19th November 2025

EMA CHMP Meeting Highlights – 10-13 November 2025

• The CHMP adopted positive opinions on 10 new medicines, including notable approvals.

• The CHMP also recommended four extensions of therapeutic indication for already-authorised medicines: Koselugo, Minjuvi, Veyvondi and Xerava.

• Withdrawals and re-examinations: Three initial marketing authorisation applications were withdrawn (Insulin Aspart Injection; Nurzigma; Ohtuvayre) and a re-examination was started for Rezurock (belumosudil). 

• In terms of numbers: 10 new positive opinions; 0 negative opinions for new medicines; 3 withdrawn applications for new medicines. Total year-to-date (2025) figures: 97 positive opinions, 6 negatives, 21 withdrawals of new medicines. 

Link: Meeting highlights – CHMP 10-13 November 2025

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