MedPath
EMA Product

Hemangiol

Product approved by European Medicines Agency (EU)

Basic Information

Hemangiol

Regulatory Information

EMEA/H/C/002621

Authorised

April 23, 2014

February 20, 2014

6

February 9, 2023

Company Information

France

Les Cauquillous 81500 - Lavaur

PIERRE FABRE MEDICAMENT

Active Ingredients

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic 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.

Overview Summary

This is a summary of the European public assessment report (EPAR) for Hemangiol. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Hemangiol. For practical information about using Hemangiol, patients should read the package leaflet or contact their doctor or pharmacist.

© Copyright 2025. All Rights Reserved by MedPath