birch bark extract

This medicine is authorised for use in the European Union.


Filsuvez is a medicine that is used in adults and children aged 6 months or older with epidermolysis bullosa (EB).

EB is an inherited disease of the skin that makes the skin very fragile and causes severe blistering and scarring. Filsuvez is used in two types of EB, dystrophic EB and junctional EB, to treat partial-thickness skin wounds. These are wounds where the upper layers of the skin have been damaged.

EB is rare, and Filsuvez was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 23 February 2011. Further information on the orphan designation can be found here:

Filsuvez contains a dry extract from two species of birch bark consisting of naturally occurring substances known as triterpenes, including betulin, betulinic acid, erythrodiol, lupeol and oleanolic acid.

This EPAR was last updated on 17/10/2023

Authorisation details

Product details
Agency product number
Active substance
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w)
International non-proprietary name (INN) or common name
birch bark extract
Therapeutic area (MeSH)
  • Epidermolysis Bullosa Dystrophica
  • Epidermolysis Bullosa, Junctional
Anatomical therapeutic chemical (ATC) code

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Amryt Pharmaceuticals DAC
Date of issue of marketing authorisation valid throughout the European Union
Contact address

45 Mespil Road
Ballsbridge Dublin 4 Co.
Dublin D04 W2F1

Product information

17/10/2023 Filsuvez - EMEA/H/C/005035 - /N/0008

Other EU languages available icon 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:

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

Preparations for treatment of wounds and ulcers

Therapeutic indication

Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.

Assessment history

Related content

How useful was this page?

Add your rating
1 rating