Betulae cortex

Birch bark used phytotherapeutically, see also betulin.

After the dry extract of birch bark was initially only used in care preparations, a gel with dry birch bark extract (72 to 88 mg betulin per g gel) was approved in 2016 for the treatment of superficial skin wounds, as well as grade IIa burn wounds in adults.

HMPC: no monograph yet, only protocol

ESCOP: not processed

Dermatological indication: Atopic dermatitis: Imlan Creme ^pur®, Imlan Lotion ^pur®

Recent clinical studies: actinic keratoses, epidermal lesions (Metelmann HR et al. 2015) .

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 granted marketing authorization 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; 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for Human Use of the European Medicines Agency (CHMP): For superficial wounds under the name ^Episalvan® Gel, meanwhile withdrawn from the market.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.

Filsuvez® approved for dystrophic and junctional epidermolysis bullosa, see also Betulin - Imlan Pur® and Implan Plus®

1. https://arzneipflanzenlexikon.info/birch.php
2. Metelmann HR et al. (2015) Accelerated reepithelialization by triterpenes: proof of concept in the healing of surgical skin lesions. Skin Pharmacol Physiol. 28: 1-11
3. Laszczyk M et al. (2006) Physical, chemical and pharmacological characterization of a new oleogel-forming triterpene extract from the outer bark of birch (betulae cortex). Planta Med.72: 1389-1395
4. Rastogi S et al. (2015) Medicinal plants of the genus Betula--traditional uses and a phytochemical-pharmacological review. J Ethnopharmacol. 159: 62-83
5. https://www.deutsche-apotheker-zeitung.de/news/artikel/2022/04/27/ein-birkenextrakt-gegen-epidermolysis-bullosa
6. https://arznei-news.de/epidermolysis-bullosa-filsuvez-birch-bark-extract-eu-approval-recommendation/#a2