Leading the way to safer medication
 Crosscheck  Recommender

GLIOLAN Powder for oral solution (2018)

Active ingredients: Aminolevulinic acid

Product Name and Form

Gliolan 30 mg/ml powder for oral solution.

Pharmaceutical form

Powder for oral solution.

The powder is a white to off-white cake.

Qualitative and Quantitative Composition

One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl).

One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.

Chemical substance
Description
Aminolevulinic acid

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

None.

Pack sizes and Marketing

Colourless type I glass bottle with butyl rubber stopper containing 1.5 g powder for reconstitution in 50 ml of drinking water.

Pack sizes: 1, 2 and 10 bottles.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

medac, Gesellschaft für klinische, Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany, Tel. + 49 4103 8006 0, Fax: +49 4103 8006 100

Date of first authorisation: 07 September 2007
Date of latest renewal: 12 September 2012

Marketing authorization number:

EU/1/07/413/001-003