VISUDYNE Powder for solution for infusion Ref.[9470] Active ingredients: Verteporfin

Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany

Product name and form

Visudyne 15 mg powder for solution for infusion.

Pharmaceutical Form
Powder for solution for infusion. Dark green to black powder.

Qualitative and quantitative composition

Each vial contains 15 mg of verteporfin.

After reconstitution, 1 ml contains 2 mg of verteporfin. 7.5 ml of reconstituted solution contains 15 mg of verteporfin.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Verteporfin	Verteporfin, also referred to as benzoporphyrin derivative monoacids (BPD-MA) consists of a 1:1 mixture of the equally active regioisomers BPD-MA_C and BPD-MA_D. It produces cytotoxic agents only when activated by light in the presence of oxygen. The selectivity of PDT using verteporfin is based, in addition to the localised light exposure, on selective and rapid uptake and retention of verteporfin by rapidly proliferating cells including the endothelium of choroidal neovasculature.

List of Excipients
Lactose monohydrate Egg phosphatidylglycerol Dimyristoyl phosphatidylcholine Ascorbyl palmitate Butylated hydroxytoluene (E321)

Pack sizes and marketing

15 mg of powder for solution for infusion in a single-use glass vial (type I), sealed with bromobutyl stopper and aluminium flip-off cap.

Pack containing 1 vial.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany

Marketing authorization dates and numbers

EU/1/00/140/001

Date of first authorisation: 27 July 2000
Date of latest renewal: 05 May 2010

Drugs

Drug	Countries
VISUDYNE	Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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