CHMP recommends marketing approval for Orion sedative dexdor
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 Orion's new intensive care sedative dexdor (dexmedetomidine).
The company expects to get the European Commission's marketing authorization approval for the intensive care sedative dexdor in few months.
When approved, the drug can be marketed by Orion in all the European Union Member States.
Dexmedetomidine is available with the brand name Precedex in more than 30 countries outside Europe, including the US (since 2000)and Japan.
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