Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Takeda Pharma A/S, Dybendal Alle 10, 2630, Taastrup, Denmark
ADCETRIS 50 mg powder for concentrate for solution for infusion.
Powder for concentrate for solution for infusion.
White to off-white cake or powder.
Each vial contains 50 mg of brentuximab vedotin.
After reconstitution (see section 6.6), each mL contains 5 mg of brentuximab vedotin.
ADCETRIS is an antibody-drug conjugate composed of a CD30-directed monoclonal antibody (recombinant chimeric immunoglobulin G1 [IgG1], produced by recombinant DNA technology in Chinese Hamster ovary cells) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE).
Excipient with known effect: Each vial contains approximately 13.2 mg of sodium.
For the full list of excipients, see section 6.1.
Citric acid monohydrate (for pH-adjustment)
Sodium citrate dihydrate (for pH-adjustment)
Type I glass vial with a butyl rubber stopper and an aluminium/plastic flip-off seal, containing 50 mg powder.
Pack of 1 vial.
Takeda Pharma A/S, Dybendal Alle 10, 2630, Taastrup, Denmark
Date of first authorisation: 25 October 2012
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