| Definition | Birch bark extract is rich in triterpenoids with beneficial biological and pharmacological activities. Some of the compounds identified in it include betulin, [lupeol], [betulinic acid], oleanolic acid, and erythrodiol.[A249945] Birch bark extract is obtained from the white part of the birch tree bark, and the main species of trees used for production are _Betula pendula_ Roth (silver birch) and _Betula pubescens_ Ehrh. (white birch), although hybrids of both species are used as well.[L42380] Two oleogel formulations of birch bark extract (Oleogel-S10, 10% of triterpene dry extract in sunflower oil) have been approved by the European Medicines Agency.[L42365,L42370] Filsuvez, one of these two formulations, is approved for the treatment of partial thickness wounds in patients with epidermolysis bullosa (EB), a rare group of hereditary disorders of the skin, mucous membranes, and internal epithelial linings characterized by extreme skin fragility and blister development.[L42390] The EMA marketing authorization for Episalvan[L42370] was withdrawn by the manufacturer in 2022. |
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