Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Biofrontera Bioscience GmbH, Hemmelrather Weg 201, 51377 Leverkusen, Germany, Tel: +49-214-87632-66, Fax: +49-214-87632-90, Email: ameluz@biofrontera.com
Ameluz 78 mg/g gel.
| Pharmaceutical Form |
|---|
|
Gel. White to yellowish gel. |
One gram (g) gel contains 78 mg of 5-aminolaevulinic acid (as hydrochloride).
Excipients with known effect: One gram gel contains 2.4 mg sodium benzoate (E211), 3 mg soybean phosphatidylcholine.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
5-Aminolevulinic acid (5-ALA) is a natural biochemical precursor of heme that is metabolised in a series of enzymatic reactions to fluorescent porphyrins, particularly PPIX. 5-ALA synthesis is regulated by an intracellular pool of free heme via a negative feedback mechanism. Administration of excess exogenous 5-ALA avoids the negative feedback control, and accumulation of PPIX occurs in target tissue. In the presence of visible light, fluorescence of PPIX (photodynamic effect) in certain target tissues can be used for photodynamic diagnosis. |
| List of Excipients |
|---|
|
Xanthan gum |
One outer carton containing one aluminium tube with epoxyphenol inner lacquer and a latex seal and a screw cap of high density polyethylene. Each tube contains 2 g of gel.
Biofrontera Bioscience GmbH, Hemmelrather Weg 201, 51377 Leverkusen, Germany, Tel: +49-214-87632-66, Fax: +49-214-87632-90, Email: ameluz@biofrontera.com
EU/1/11/740/001
Date of first authorisation: 14 December 2011
Date of latest renewal: 21 November 2016
| Drug | Countries | |
|---|---|---|
| AMELUZ | Austria, Estonia, Spain, France, Croatia, Ireland, Lithuania, Poland, United Kingdom, United States |
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