European approval for Ozalin as premedication before procedures in children.- Primex Pharma

Primex Pharmaceuticals AG announces it has received marketing authorization (MA) in the EU via the decentralised procedure for Ozalin (ADV 6209) for children from 6 months to 17 years for moderate sedation before therapeutic or diagnostic procedures, and as premedication prior to anaesthesia. Primex Pharmaceuticals acquired the global rights for Ozalin from the French pharmaceutical development company Advicenne SA.

Comment: Premedication may be administered to reduce the preoperative anxiety. However, one of the challenges facing paediatric anaesthesiologists is the lack of suitable medications, either due to their lack of acceptability, or their being unregistered and therefore used outside of their medical indication. An innovative oral solution for children, Ozalin (ADV6209>, has been developed to improve the management of paediatric sedation.