The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) held their monthly meeting last week and have just published the highlights from the meeting.
At this meeting, eleven approvals were recommended, five of which were orphan medicines. Two medicines received negative opinions, one for the treatment of schizophrenia and one for the treatment of breast cancer with brain metastases. Eight medicines were granted extensions of indication and one medicine withdrew their marketing authorisation application.
The CHMP also recommended a restriction on the use of some linear gadolinium agents used with MRI scans. They have also agreed to re-examine its opinion on Alcover which was given in the June 2017 meeting.
For a meeting summary and a full list of approvals, opinions and withdrawals, click here.