Allergan Receives Positive Opinion Through European Decentralised Procedure For BELKYRA® (Deoxycholic Acid) For Submental Fullness

06/30/2016

The Swedish Medical Products Agency (MPA)  gave its thumbs up to Allergan’s BELKYRA® (deoxycholic acid). BELKYRA® is being evaluated through the Decentralised Procedure, with the Swedish MPA acting as the Reference Member State for 20 other countries in the European Union, as well as Iceland and Norway.

Known as Kybella in the US and Canada, BELKYRA® will be the first prescription medicine to be licensed in Europe for the treatment of moderate-to-severe fullness associated with submental fat in adults when the presence of submental fat has a psychological impact for the patient.

As a next step, Allergan will work to secure the national Marketing Authorizations in the Concerned Member States. Once the national licenses have been granted, Allergan will begin to train healthcare professional customers on the use of this new treatment. Allergan is already working with other health regulatory agencies around the world to bring this valuable treatment option to people with submental fullness. 

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