Filsuvez
birch bark extract
Table of contents
Overview
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
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.
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List item
Filsuvez : EPAR - Medicine Overview (PDF/106.53 KB)
First published: 04/07/2022
EMA/239723/2022 -
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Filsuvez : EPAR - Risk management plan summary (PDF/161.22 KB)
First published: 04/07/2022
Authorisation details
Product details | |
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Name |
Filsuvez
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Agency product number |
EMEA/H/C/005035
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Active substance |
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w)
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International non-proprietary name (INN) or common name |
birch bark extract
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
D03AX13
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Orphan |
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 | |
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Marketing-authorisation holder |
Amryt Pharmaceuticals DAC
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Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
21/06/2022
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Contact address |
45 Mespil Road |
Product information
04/10/2022 Filsuvez - EMEA/H/C/005035 - IB/0001/G
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
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.