Batch of recommendations from EMA/CHMP

Of the five marketing approval requests reviewed at the April 2015 meeting of the European Medicines agency’s Committee for Medicinal Products for Human Use (CHMP), four received a positive opinion, and one did not.

The recommendations will be reviewed and the European Commission is expected to give a final decision in around two months time. Once a marketing authorization has been granted, a decision about price and reimbursement will take place at the level of each European Union member state considering the potential role/use of this medicine in the context of the national health system of that country.

Positive opinions for Opdivo, Hetlioz, LuMark and Lixiana