TOOKAD Powder for solution for injection Ref.[7650] Active ingredients: Padeliporfin

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Steba Biotech S.A., 7 Place du Théâtre, L-2613, Luxembourg, Luxembourg

Product name and form

TOOKAD 183 mg powder for solution for injection.

TOOKAD 366 mg powder for solution for injection.

Pharmaceutical Form

Powder for solution for injection. The powder is a dark lyophilisate.

Qualitative and quantitative composition

TOOKAD 183 mg powder for solution for injection: Each vial contains 183 mg of padeliporfin (as di-potassium salt).

TOOKAD 366 mg powder for solution for injection: Each vial contains 366 mg of padeliporfin (as di-potassium salt).

1 mL of reconstituted solution contains 9.15 mg of padeliporfin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Padeliporfin

Padeliporfin is retained within the vascular system. When activated with 753 nm wavelength laser light, padeliporfin triggers a cascade of pathophysiological events resulting in focal necrosis within a few days.

List of Excipients

Mannitol (E421)

Pack sizes and marketing

TOOKAD 183 mg powder for solution for injection: Amber type I glass vial, sealed with a rubber stopper crimped with an aluminium seal and covered with a blue plastic flip-off cap, containing 183 mg padeliporfin.

Pack size: 1 vial

TOOKAD 366 mg powder for solution for injection: Amber type I glass vial, sealed with a rubber stopper crimped with an aluminium seal and covered with a white plastic flip-off cap, containing 366 mg padeliporfin.

Pack size: 1 vial

Marketing authorization holder

Steba Biotech S.A., 7 Place du Théâtre, L-2613, Luxembourg, Luxembourg

Marketing authorization dates and numbers

EU/1/17/1228/001
EU/1/17/1228/002

10 November 2017

Drugs

Drug Countries
TOOKAD Austria, Estonia, Ireland, Lithuania, Poland

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