Preferred Label : Oleogel-S10;
NCIt synonyms : Oleogel S10; Birch Triterpenes-containing Topical Gel; Betulin-rich Oleogel-S10; Betulin-rich Extract Oleogel-S10;
NCIt definition : A topical gel formulation containing 10% birch tree bark (Betulae cortex) extract
in 90% sunflower oil, with potential wound healing accelerating activities in various
skin conditions, including epidermolysis bullosa (EB), partial thickness wounds and
dermatitis. The birch bark extract is rich in the birch triterpene betulin and also
contains lupeol, betulinic acid, erythrodiol and oleanolic acid. Upon topical administration
of oleogel-S10 to the affected areas, the birch bark extract, containing mostly betulin,
stimulates keratinocytes migration and differentiation into epithelial skin cells,
thereby accelerating wound closure, skin restoration and wound healing. It also regulates
the inflammatory response involved in wound healing, which further accelerates wound
repair. This may decrease the wound healing process time and may reduce radiation
dermatitis upon external beam radiation therapy.;
Drug name : Episalvan; Filsuvez;
Molecule name : AP101;
NCI Metathesaurus CUI : CL1773602;
Origin ID : C185347;
UMLS CUI : C5669860;
See also inter- (CISMeF)
Semantic type(s)
concept_is_in_subset
https://www.ema.europa.eu/en/medicines/human/EPAR/filsuvez
2022
false
false
false
Netherlands
French
English
Oleogel-S10
Oleogel-S10
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Betulae cortex
orphan drug production
epidermolysis bullosa, junctional
adult
child
adolescent
betula
plant extracts
epidermolysis bullosa dystrophica
plant bark
drug approval
europe
administration, cutaneous
gels
pregnancy
breast feeding
drug evaluation, preclinical
aged
---
https://www.has-sante.fr/jcms/p_3394096/fr/filsuvez-extrait-sec-raffine-d-ecorce-de-bouleau-epidermolyse-bulleuse-dystrophique
2022
false
false
false
France
plant extracts
treatment outcome
insurance, health, reimbursement
epidermolysis bullosa dystrophica
infant
child
adolescent
adult
aged
gels
administration, cutaneous
Oleogel-S10
Betulae cortex
evaluation of the transparency committee
plant bark
betula
---
https://ansm.sante.fr/tableau-acces-derogatoire/oleogel-s-10
2022
false
false
false
France
French
drug information
Betulae cortex
Oleogel-S10
---