Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
MINJUVI 200 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Powder for concentrate for solution for infusion (powder for concentrate). White to slightly yellowish lyophilised powder. |
One vial of powder contains 200 mg of tafasitamab.
After reconstitution each mL of solution contains 40 mg of tafasitamab.
Tafasitamab is a humanised CD19-specific monoclonal antibody of the immunoglobulin G (IgG) subclass produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology.
Excipient with known effect: Each vial of MINJUVI contains 7.4 mg of sodium. For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tafasitamab |
Tafasitamab is an Fc-enhanced monoclonal antibody that targets the CD19 antigen expressed on the surface of pre-B and mature B lymphocytes. Upon binding to CD19, tafasitamab mediates B-cell lysis. The Fc modification results in enhanced antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. |
| List of Excipients |
|---|
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Sodium citrate dihydrate |
Clear type I glass vial with a butyl rubber stopper, aluminium seal and a plastic flip-off cap containing 200 mg tafasitamab. Pack size of one vial.
Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
EU/1/21/1570/001
Date of first authorisation: 26 August 2021
| Drug | Countries | |
|---|---|---|
| MINJUVI | Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, United Kingdom |
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