birch bark

Last updated on: 11.01.2025

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Definition
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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for Human Use of the European Medicines Agency (CHMP): For superficial wounds under the name Episalvan Gel, meanwhile withdrawn from the market.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/use
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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

Undesirable effects
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Local itching and pain

Preparations
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Episalvan® , but has since been withdrawn from the market, Filsuvez® approved for dystrophic and junctional epidermolysis bullosa, see also Betulin - Imlan Pur® and Implan Plus®

Literature
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  1. https://arzneipflanzenlexikon.info/birch.php
  2. https://arznei-news.de/birch-bark-extract/
  3. https://www.deutsche-apotheker-zeitung.de/news/artikel/2022/04/27/ein-birkenextrakt-gegen-epidermolysis-bullosa
  4. https://arznei-news.de/epidermolysis-bullosa-filsuvez-birch-bark-extract-eu-approval-recommendation/#a2

Incoming links (1)

Betula alba;

Last updated on: 11.01.2025