Orion receives positive CHMP opinion for new intensive care sedative, dexdor® (dexmedetomidine)
26-Jul-2011
- Finland
Orion Corporation has received information that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the granting of marketing authorisation for dexdor® (dexmedetomidine), a new intensive care sedative.
The European Commission is expected to make the final decision on marketing authorisation in the coming months. If approved by the European Commission Orion would receive marketing authorisation for dexdor® in all European Union Member States.
Orion submitted a marketing authorisation application for dexmedetomidine for the evaluation by the European Medicines Agency in October 2010.
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