B · Normal
[Hansoh Pharmaceutical responded to the withdrawal of the EU approval for Ametinib: The procedural issue has nothing to do with product quality and the application will be re-opened as soon as possible] On September 27, Hansoh Pharmaceutical announced that the European Commission (EC) announced the withdrawal of the marketing authorization of Ametinib mesylate tablets in the EU. According to the announcement, the revocation was due to AstraZeneca's lawsuit against the European Commission. The reason for the European Commission's revocation of the marketing authorization of Ametinib was not the quality, safety or effectiveness of the drug itself, but a purely procedural issue in the regulatory evaluation process. Hansoh Pharmaceutical's announcement mentioned that after this revocation, the company will re-initiate the application for marketing authorization of Ametinib in the EU as soon as possible, and will still adhere to its innovation and internationalization strategy.
medicine 🕐 2026-09-27 21:21

Related telegraphs

Comments

0/500
Captcha (click to refresh)
No comments yet