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Home Industry News Orion receives backing for EU approval of dexdor sedative

Orion receives backing for EU approval of dexdor sedative

26th July 2011

Orion's application for approval of the intensive care sedative dexdor has received the backing of a European Medicines Agency committee.

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for marketing authorisation for the relatively selective alpha2-agonist, which produces sedation by acting on the central nervous system.

Orion has submitted the compound for approval in October 2010 for use among intensive care patients requiring a sedation level no deeper than arousal in response to verbal stimulation.

Dexdor is a dexmedetomidine-based compound that is already distributed by Hospira in more than 30 non-EU nations under the name Precedex, with approval in the US and Japan occurring in 2000 and 2004 respectively.

Should the European Commission choose to follow the CHMP recommendation as expected, it will be made available for sale in all of the EU member states.

Orion is expecting to experience year-on-year business growth in 2011 after enjoying a strong performance in 2010, a period in which it saw a net sales improvement of ten percent.ADNFCR-8000103-ID-800633866-ADNFCR

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