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for Human Use of the European Medicines Agency (CHMP): For superficial wounds under the name Episalvan® Gel, meanwhile withdrawn from the market.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