Press Release: European Medicines Agency gives second positive opinion for a paediatric-use marketing authorisation

The European Medicines Agency's Committee for Medicinal Products for Human use (CHMP) in February 2014 recommended granting a paediatric-use marketing authorisation (PUMA) for Hemangiol for the treatment of proliferating infantile haemangioma. This is the second time that the CHMP has granted a positive opinion for a PUMA since their introduction by the Paediatric Regulation, which came into force in 2007.

• Primary Source

ESO: Background information: Press Release: European Medicines Agency gives first positive opinion for paediatric-use marketing authorisation http://www.europeansources.info/record/press-release-european-medicines-agency-gives-first-positive-opinion-for-paediatric-use-marketing-authorisation/

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