PHOTOBARR Powder for solution for injection Ref.[9109] Active ingredients: Porfimer

Source: European Medicines Agency (EU)  Revision Year: 2012  Publisher: Pinnacle Biologics B.V., p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, 1043 DP Amsterdam, The Netherlands

Product name and form

PhotoBarr 15 mg powder for solution for injection.

Pharmaceutical Form

Powder for solution for injection.

A dark red to reddish brown lyophilised powder or cake.

Qualitative and quantitative composition

Each vial contains 15 mg porfimer sodium. After reconstitution, each ml solution contains 2.5 mg porfimer sodium.

For a full list of excipients, see 6.1.

Active Ingredient Description
Porfimer

Porfimer is a mixture of porphyrin units, which are linked together in chains of two to eight units The cytotoxic actions of porfimer are light- and oxygen-dependent. Photodynamic therapy with porfimer is a 2-stage process. Cellular damage caused by porfimer PDT is a consequence of the propagation of free radical reactions.

List of Excipients

Hydrochloric acid (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)

Pack sizes and marketing

15 mg powder in a vial (glass type I, 7 ml capacity) with a grey butyl stopper.

Pack size: 1 vial.

Marketing authorization holder

Pinnacle Biologics B.V., p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, 1043 DP Amsterdam, The Netherlands

Marketing authorization dates and numbers

EU/1/04/272/001

Date of first authorisation: 25 March 2004

Date of latest renewal: 4 March 2009

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