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: [ema.europa.eu/medicines/human/orphan-designations/eu-310845](/en/medicines/human/orphan-designations/eu-3-10-845) 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.
Therapeutic Indication
### Therapeutic indication Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.
Therapeutic Area (MeSH)
ATC Code
D03AX13
ATC Item
Betulae cortex
Pharmacotherapeutic Group
Preparations for treatment of wounds and ulcers
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w) | N/A | dry extract from birch bark (der 5-10 : 1), extraction solvent n-heptane 95% (w/w) |
EMA Name
Filsuvez
Medicine Name
Filsuvez
Aliases
N/ANo risk management plan link.
