USA-based drugmaker The Medicines Company (Nasdaq: MDCO) said yesterday that the European Commission has granted marketing authorization for three of its hospital acute care products – Kengrexal (cangrelor), Orbactiv (oritavancin) and Raplixa (sealant powder).
These approvals follow the issuance of positive opinions in January by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The marketing authorization for each of these products is now valid in the 31 countries of the European Economic Area (EEA), which includes all 28 European Union (EU) Member States, plus Norway, Iceland and Liechtenstein.
“The EEA includes a population of more than 500 million people. Securing market authorization for these three acute care treatments opens the door for us and our partners to potentially improve patient care for many patients in European hospitals. We are grateful to the member state authorities, the European Medicines Agency and the European Commission for their timely review and approval of our applications,” said Clive Meanwell, chairman and chief executive of The Medicines Company.
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