birch bark

Last updated on: 31.07.2022

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Definition
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s.a. betulin. Initially processed only in care preparations. Since 2016, a gel with birch bark dry extract (72-88 mg betulin per g gel) has been granted approval with the indication "Treatment of superficial skin wounds (epidermis and upper dermis) and grade IIa burn wounds of the skin in adults":

Dry extract (DEV 5-10:1; extraction agent 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Products for Human Use of the European Medicines Agency (CHMP): for superficial wounds under the name Episalvan Gel, withdrawn from the market in the meantime.

On 06/24/2022, the EMA Committee for Medicinal Products for Human Use (CHMP) granted marketing authorization to Filsuvez birch bark extract 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Episalvan®, but since withdrawn from the market, Filsuvez approved for dystrophic and junctional epidermolysis bullosa, see also Betulin - Imlan Pur® and Implan Plus®.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/index.php?en_pflanzen=4
  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

Outgoing links (1)

Betulin;

Last updated on: 31.07.2022