Summary of opinion: Krazati,adagrasib, 09/11/2023, Positive

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023

Summary of opinion: Pradaxa,dabigatran etexilate, 09/11/2023, Positive

Withdrawn application: Vijoice, alpelisib, Date of withdrawal: 30/10/2023, Initial authorisation

Referral: Azithromycin-containing medicinal products for systemic use, azithromycin, Article 31 referrals, Procedure started

Summary of opinion: Mounjaro,tirzepatide, 09/11/2023, Positive

Nitrosamine impurities

Referral: Havrix, hepatitis A virus (inactivated, adsorbed), associated names: Havrix and associated names, Article 30 referrals, Under evaluation, 14/09/2023, 10/11/2023

Opinion/decision on a Paediatric investigation plan (PIP): 2-{4-[4-(4-{5-[(1S)-1-amino-1-(4-fluorophenyl) ethyl]pyrimidin-2-yl}piperazin-1-yl)pyrrolo[2,1-f] [1,2,4]triazin-6-yl]-1H-pyrazol-1-yl}ethan-1-ol, decision type: , therapeutic area: , PIP number: P/0479/2022

Academia Info Day, European Medicines Agency, Amsterdam, 09:30 - 13:30 (CET), from 10/11/2023 to 10/11/2023