FOSCAN Solution for injection Ref.[9097] Active ingredients: Temoporfin

Source: European Medicines Agency (EU)  Revision Year: 2016  Publisher: biolitec Pharma Ltd., Otto-Schott-Str. 15, 07745, Jena, Germany

Product name and form

Foscan 1 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Dark purple solution.

Qualitative and quantitative composition

Each ml contains 1 mg of temoporfin.

Excipients with known effect: Each ml contains 376 mg of ethanol anhydrous and 560 mg of propylene glycol.

For the full list of excipients, see section 6.1

Active Ingredient Description
Temoporfin

Temoporfin is a photosensitising agent used in the photodynamic therapy of tumours.

List of Excipients

Ethanol, anhydrous (E1510)
Propylene glycol (E1520)

Pack sizes and marketing

Type I amber glass vials with a bromobutyl elastomer stopper and aluminium seal containing either 1 ml or 3 ml or 6 ml of solution for injection.

Each pack contains 1 vial and a filter with Luer lock connections for syringe and cannula. Not all pack sizes may be marketed.

Marketing authorization holder

biolitec Pharma Ltd., Otto-Schott-Str. 15, 07745, Jena, Germany

Marketing authorization dates and numbers

EU/1/01/197/003
EU/1/01/197/004
EU/1/01/197/005

Date of first authorisation: 24 October 2001

Date of latest renewal: 22 September 2011

Drugs

Drug Countries
FOSCAN Austria, Estonia, France, Ireland, Lithuania, Netherlands, Poland, United Kingdom

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