Hemangiol

RSS

propranolol

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 06/04/2018

Authorisation details

Product details
Name
Hemangiol
Agency product number
EMEA/H/C/002621
Active substance
propranolol hydrochloride
International non-proprietary name (INN) or common name
propranolol
Therapeutic area (MeSH)
Hemangioma
Anatomical therapeutic chemical (ATC) code
C07AA05
Publication details
Marketing-authorisation holder
Pierre Fabre Dermatologie
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
23/04/2014
Contact address
Les Cauquillous
81506 Lavaur
France

Product information

14/03/2018 Hemangiol - EMEA/H/C/002621 - N/0013

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

BETA BLOCKING AGENTS

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

Assessment history

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