Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Hemangiol   
Auth. number : EU/1/14/919
INN : propranolol
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C07 - Beta blocking agents
Pharmacological subgroup: C07A - Beta blocking agents, plain
Chemical subgroup: C07AA - Beta blocking agents, plain, non-selective
Chemical substance: C07AA05 - Propranolol
(See WHO ATC Index)
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
Marketing Authorisation Holder: Pierre Fabre Dermatologie
45 place Abel Gance, F- 92100 Boulogne, France

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/04/2014 Centralised - Authorisation EMEA/H/C/2621 (2014)2808 of 23/04/2014
10/07/2014 Centralised - Variation EMEA/H/C/2621/IB/1/G