Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland
Kesimpta 20 mg solution for injection in pre-filled syringe.
Kesimpta 20 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Solution for injection (injection) in pre-filled pen (Sensoready Pen). The solution is clear to slightly opalescent, and colourless to slightly brownish-yellow. |
Kesimpta 20 mg solution for injection in pre-filled syringe:
Each pre-filled syringe contains 20 mg ofatumumab in 0.4 ml solution (50 mg/ml).
Kesimpta 20 mg solution for injection in pre-filled pen:
Each pre-filled pen contains 20 mg ofatumumab in 0.4 ml solution (50 mg/ml).
Ofatumumab is a fully human monoclonal antibody produced in a murine cell line (NS0) by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ofatumumab |
Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B-cell tumours. The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complement dependent cytotoxicity and resultant lysis of tumour cells. |
| List of Excipients |
|---|
|
L-arginine |
Kesimpta 20 mg solution for injection in pre-filled syringe:
Kesimpta is supplied in a single-use glass syringe, equipped with a stainless steel needle, a plunger stopper and a rigid needle shield. The syringe is assembled with a plunger rod and a needle safety device.
Kesimpta is available in unit packs containing 1 pre-filled syringe and in multipacks containing 3 (3 packs of 1) pre-filled syringes.
Not all pack sizes may be marketed.
Kesimpta 20 mg solution for injection in pre-filled pen:
Kesimpta is supplied in a single-use glass syringe, equipped with a stainless steel needle, a plunger stopper and a rigid needle shield. The syringe is assembled into an auto-injector.
Kesimpta is available in unit packs containing 1 pre-filled pen and in multipacks containing 3 (3 packs of 1) pre-filled pens.
Not all pack sizes may be marketed.
Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland
EU/1/21/1532/001-004
26 March 2021
| Drug | Countries | |
|---|---|---|
| KESIMPTA | Brazil, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States |
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