Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Amryt GmbH, Streiflingsweg 11, 75223 Niefern-Öschelbronn, Germany tel +49 (0) 7233 9749 0 fax +49 (0) 7233 9749 – 210 Email: info.de@amrytpharma.com
Episalvan gel.
| Pharmaceutical Form |
|---|
|
Gel. Colourless to slightly yellowish, opalescent. |
1 g gel contains: 100 mg extract (as dry extract, refined) from birch bark from Betula pendula Roth, Betula pubescens Ehrh. as well as hybrids of both species (equivalent to 0.5-1.0 g birch bark), corresponding to 72-88 mg betulin.
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 μg/ml, and in a porcine ex vivo wound healing model at the dosage of 10 µg/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 tubes are closed with a tamper-evident aluminium membrane and fitted with a white polypropylene screw cap. The tube is packed in a cardboard box.
Pack size: 1 tube containing 23.4 g gel.
Amryt GmbH, Streiflingsweg 11, 75223 Niefern-Öschelbronn, Germany
tel +49 (0) 7233 9749 – 0
fax +49 (0) 7233 9749 – 210
Email: info.de@amrytpharma.com
EU/1/15/1069/001
Date of first authorisation: 14 January 2016
| Drug | Countries | |
|---|---|---|
| EPISALVAN | Estonia, Poland |
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