CHMP recommends Hemangiol for treatment of infantile Haemangioma - Pierre Fabre

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Hemangiol, 3.75mg/ml, oral solution from Pierre Fabre and intended for the treatment of proliferating infantile haemangioma requiring systemic therapy.

A pharmacovigilance plan for Hemangiol will be implemented as part of the marketing authorisation and it is to be initiated in infants aged 5 weeks to 5 months. It is proposed that Hemangiol be prescribed by physicians who have expertise in the diagnosis, treatment and management of infantile haemangioma.

Infantile hemangioma are red blemishes or bumps made up of small blood vessels. They affect around 3 to 10% of children born, and may appear on the head, face and neck in approximately 50% of cases. They are often not present at birth and usually become more obvious in the first weeks thereafter.