Source: European Medicines Agency (EU) | Revision Year: 2019 | Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany
Visudyne 15 mg powder for solution for infusion.
Powder for solution for infusion.
Dark green to black powder.
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.
Verteporfin, also referred to as benzoporphyrin derivative monoacids (BPD-MA) consists of a 1:1 mixture of the equally active regioisomers BPD-MAC and BPD-MAD. 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.
Butylated hydroxytoluene (E321)
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.
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany
Date of first authorisation: 27 July 2000
Date of latest renewal: 05 May 2010
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