ADCETRIS Powder for concentrate for solution Ref.[6593] Active ingredients: Brentuximab vedotin

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Takeda Pharma A/S, Dybendal Alle 10, 2630, Taastrup, Denmark

Product name and form

ADCETRIS 50 mg powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

White to off-white cake or powder.

Qualitative and quantitative composition

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.

Active Ingredient
List of Excipients

Citric acid monohydrate (for pH-adjustment)
Sodium citrate dihydrate (for pH-adjustment)
α,α-Trehalose dihydrate
Polysorbate 80

Pack sizes and marketing

Type I glass vial with a butyl rubber stopper and an aluminium/plastic flip-off seal, containing 50 mg powder.

Pack of 1 vial.

Marketing authorization holder

Takeda Pharma A/S, Dybendal Alle 10, 2630, Taastrup, Denmark

Marketing authorization dates and numbers


Date of first authorisation: 25 October 2012


Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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