From their meeting in November, the EMA (European Medicines Agency) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
At this meeting there were ten recommendations for approvals of medicines, two of which were orphan medicines, one biosimilar medicine and three generic medicines.
The CHMP also published the findings from their re-examination of two negative recommendations adopted at the July 2017 meeting. In both cases the CHMP confirmed their previous recommendations to refuse marketing authorisations for the two medicines.
The CHMP stated four recommendations on extensions of therapeutic indication and no negative opinions on new drugs. Applications for initial marketing authorisations have been withdrawn for two medicines.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.