Hemangiol (propranolol)
- Region
- 🇪🇺 EU
- Active substance
- propranolol
- Company
- Pierre Fabre Medicament
- Status
- Authorised
- Therapeutic area
- Hemangioma
- CHMP opinion
- Thu 20 Feb 2014
- EU approval
- Wed 23 Apr 2014
- Application
- EMEA/H/C/002621
- ATC
- C07AA05
- Official record
- www.ema.europa.eu
Indication
Hemangiol is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy: Life- or function-threatening haemangioma, Ulcerated haemangioma with pain and/or lack of response to simple wound care measures, Haemangioma with a risk of permanent scars or disfigurement. It is to be initiated in infants aged 5 weeks to 5 months.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.