Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Lumoxiti 1 mg powder for concentrate and solution for solution for infusion.
| Pharmaceutical Form |
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Powder for concentrate and solution for solution for infusion. Powder for concentrate: white to off-white lyophilised powder. Solution (stabiliser): colourless-to-slightly yellow, clear solution with a pH of 6.0. |
One vial of powder for concentrate contains 1 mg moxetumomab pasudotox.
Reconstitution with water for injections results in a final moxetumomab pasudotox vial concentration of 1 mg/mL.
Moxetumomab pasudotox is produced in Escherichia coli cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| List of Excipients |
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Powder for concentrate: Sodium dihydrogen phosphate monohydrate Solution (stabiliser): Citric acid monohydrate |
Lumoxiti 1 mg powder for concentrate is provided in a Type 1 glass vial with an elastomeric stopper and a dark blue flip-off aluminium seal.
The 1 mL solution (stabiliser) is provided in a Type 1 glass vial with an elastomeric stopper and a dark grey flip-off aluminium seal.
Each pack contains:
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/20/1522/001 2 vials + 1 vial
EU/1/20/1522/002 3 vials + 1 vial
| Drug | Countries | |
|---|---|---|
| LUMOXITI | Brazil, Estonia, Lithuania, Poland, United States |
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