Hemangiol
propranolol
Table of contents
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.
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List item
Hemangiol : EPAR - Summary for the public (PDF/78.41 KB)
First published: 19/05/2014
Last updated: 19/05/2014
EMA/252150/2014 -
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Hemangiol : EPAR - Risk-management-plan summary (PDF/59.29 KB)
First published: 19/05/2014
Last updated: 21/10/2020
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 |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
23/04/2014
|
Contact address |
Les Cauquillous
81506 Lavaur France |
Product information
28/11/2019 Hemangiol - EMEA/H/C/002621 - II/0019
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.