Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Amryt Pharmaceuticals DAC, 45 Mespil Road, Dublin 4, Ireland tel: 00 800 4447 4447 (toll free) tel: +44 1604 549 952 e-mail: medinfo@amrytpharma.com
Filsuvez gel.
| Pharmaceutical Form |
|---|
|
Gel. Colourless to slightly yellowish, opalescent, non-aqueous gel. |
1 g of gel contains 100 mg of extract (as dry extract, refined) from Betula pendula Roth, Betula pubescens Ehrh. as well as hybrids of both species, cortex (equivalent to 0.5-1.0 g birch bark), including 84-95 mg triterpenes calculated as the sum of betulin, betulinic acid, erythrodiol, lupeol and oleanolic acid.
Extraction solvent: n-Heptane.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Betulin |
Betulin accelerated re-epithelialization in an in vitro wound scratch assay using human primary keratinocytes at the dosage of 1 ฮผg/ml, and in a porcine ex vivo wound healing model at the dosage of 10 ยตg/ml. The precise mechanism of action of the active substance in wound healing in humans is not known. |
| List of Excipients |
|---|
|
Sunflower oil, refined |
White collapsible aluminium tube, interior lacquered with epoxy phenolic coating, and with a sealing compound in the fold. The tube is closed with a tamper-evident aluminium membrane and fitted with a white polypropylene screw cap. The tube is packed in a carton.
Pack sizes: 1 tube of 9.4 g or 23.4 g gel.
Not all pack sizes may be marketed.
Amryt Pharmaceuticals DAC, 45 Mespil Road, Dublin 4, Ireland
tel: 00 800 4447 4447 (toll free)
tel: +44 1604 549 952
e-mail: medinfo@amrytpharma.com
EU/1/22/1652/001 9.4 g tube
EU/1/22/1652/002 23.4 g tube
| Drug | Countries | |
|---|---|---|
| FILSUVEZ | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Romania, United Kingdom |
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