Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Steba Biotech S.A., 7 Place du Théâtre, L-2613, Luxembourg, Luxembourg
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. |
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) |
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
Steba Biotech S.A., 7 Place du Théâtre, L-2613, Luxembourg, Luxembourg
EU/1/17/1228/001
EU/1/17/1228/002
10 November 2017
| Drug | Countries | |
|---|---|---|
| TOOKAD | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland |
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