On May 29, 2020, the European Medicines Agency (EMA) has published outcomes of the meeting of the Committee for Medicinal Products for Human Use (CHMP). Eight (8) positive opinions on new medicines, five (5) recommendations on extensions of therapeutic indications, and two (2) withdrawn applications for new medicines were made.
Positive opinions on new medicines:
- The new Ebola vaccine consisting of two components - Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo)
- Hepcludex (bulevirtide)
- Piqray (alpelisib)
- Rozlytrek (entrectinib)
- Xenleta (lefamulin)
- Zercepac (trastuzumab)
- Apixaban Accord (apixaban)
There were no negative recommendations on new medicines.
Positive opinions on extensions of therapeutic indications were granted to Invokana, Lynparza, Ofev, Sivextro, and Taltz.
Applications for initial marketing authorisations for Erlotinib Accord (erlotinib) and Fingolimod Mylan (fingolimod) have been withdrawn.
The CHMP meetings are held each month.
See all the details about this meeting and other details of the recommendations in English here
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