"Key Takeaways from CHMP Meeting: January 2024"
TL;DR Summary
The Committee for Medicinal Products for Human Use (CHMP) recommended three new medicines for approval, including Exblifep for urinary tract infections, Ryzneuta for neutropenia, and Niapelf for schizophrenia, while refusing marketing authorizations for Nezglyal and Syfovre. The committee also recommended extensions of therapeutic indication for four medicines and confirmed its original recommendation to not renew the conditional marketing authorization for Translarna. Additionally, the CHMP endorsed measures to minimize risks for medicines containing pseudoephedrine and will re-examine its opinion on generic medicines following a request.
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