Gliolan 30mg/ml powder for oral solution

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

One ml of reconstituted solution contains 23.4 mg of 5-aminolevulinic acid, corresponding to 30 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).

List of Excipients

None.

Pack sizes and marketing

Colourless type II glass vial, with rubber stopper.

Pack sizes: 1, 2 and 10 vials of powder.

Not all pack sizes may be marketed.

Marketing authorization holder

Medac
Gesellschaft für klinische
Spezialpräparate mbH
Fehlandtstraße 3
D-20354 Hamburg,
Germany

Tel. + 49 4103 8006 0
Fax: +49 4103 8006 100

Marketing authorization dates and numbers

EU/1/07/413/001-003

07.09.2007

Drugs

Drug
Countries
Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom