KIMMTRAK Concentrate for solution for infusion Ref.[49841] Active ingredients: Tebentafusp

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Immunocore Ireland Limited, Unit 1, Sky Business Centre, Dublin 17, D17 FY82, Ireland

Product name and form

KIMMTRAK 100 micrograms/0.5 mL concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion (sterile concentrate).

Clear, colourless to slightly yellowish solution in a single-dose vial.

Qualitative and quantitative composition

One 0.5 mL vial contains 100 micrograms of tebentafusp, corresponding to a concentration before dilution of 200 mcg/mL.

Tebentafusp is a fusion protein, produced by recombinant DNA technology in Escherichia coli cells.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tebentafusp

Tebentafusp is a bispecific fusion protein, comprised of a T cell receptor (TCR; targeting domain) fused to an antibody fragment targeting CD3 (cluster of differentiation 3; effector domain). The TCR end binds with high affinity to a gp100 peptide presented by human leukocyte antigen – A*02:01 (HLA-A*02:01) on the cell surface of uveal melanoma tumour cells, and the effector domain binds to the CD3 receptor on the polyclonal T cell.
List of Excipients

Citric acid monohydrate (E330)
Di-sodium hydrogen phosphate (E339)
Mannitol (E421)
Trehalose
Polysorbate 20 (E432)
Water for injections

Pack sizes and marketing

Type I glass vial with a bromobutyl rubber stopper and an aluminium/plastic flip-off seal, containing 0.5 mL concentrate.

Pack size of 1 vial.

Marketing authorization holder

Immunocore Ireland Limited, Unit 1, Sky Business Centre, Dublin 17, D17 FY82, Ireland

Marketing authorization dates and numbers

EU/1/22/1630/001

Drugs

Drug Countries
KIMMTRAK Estonia, France, Croatia, Israel, Italy, Lithuania, Poland, Romania, United States
 
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