European Commission approves Hemangiol for treatment of Hemangioma- Pierre Fabre
Pierre Fabre Dermatologie Laboratories have, on 6 May 2014, obtained European Commission authorization to market Hemangiol (propranolol), the first and only drug to be approved for the treatment of �proliferating infantile Hemangioma requiring systemic treatment�. Hemangiol is an oral solution specially developed for paediatric use. It will be launched firstly in France and Germany, and gradually throughout other European markets.
This European agreement follows the FDA approval obtained on March 14th 2014 for Hemangeol, the trade name of the identical drug to be launched in the US in June 2014.
This PUMA (Paediatric Use Marketing Authorization) is only the second of its type, for all pathologies, that the European Medicines Agency (EMA) has issued since the system was established in 2007