DefinitionThis section has been translated automatically.
see also Betulin. Initially only used in skin care products. Since 2016, a gel with dry birch bark extract (72 to 88 mg betulin per g gel) has been approved for the indication "Treatment of superficial skin wounds (epidermis and upper dermis) and grade IIa skin burns in adults":
Dry extract (DEV 5-10:1; extractant heptane; equivalent to 72-88 mg betulin/g gel) in gel
Committee for Medicinal Products for Human Use of the European Medicines Agency (CHMP): For superficial wounds under the name Episalvan Gel, meanwhile withdrawn from the market.
On 24.06.2022, the Committee for Medicinal Products for Human Use (CHMP) of the EMA granted marketing authorization for the birch bark extract Filsuvez for the treatment of superficial wounds associated with dystrophic and junctional epidermolysis bullosa. The gel is applied locally to the affected skin areas.
Field of application/useThis section has been translated automatically.
Episalvan: as a gel on the skin wound
EMA marketing authorisation recommendation for superficial wounds
EU approval for the treatment of superficial wounds in adults
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Undesirable effectsThis section has been translated automatically.
Local itching and pain
PreparationsThis section has been translated automatically.
Episalvan® , but has since been withdrawn from the market, Filsuvez® approved for dystrophic and junctional epidermolysis bullosa, see also Betulin - Imlan Pur® and Implan Plus®
LiteratureThis section has been translated automatically.
- https://arzneipflanzenlexikon.info/birch.php
- https://arznei-news.de/birch-bark-extract/
- https://www.deutsche-apotheker-zeitung.de/news/artikel/2022/04/27/ein-birkenextrakt-gegen-epidermolysis-bullosa
- https://arznei-news.de/epidermolysis-bullosa-filsuvez-birch-bark-extract-eu-approval-recommendation/#a2