Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Lindis Biotech GmbH, Zeppelinstraße 4, 82178 Puchheim, Germany
Korjuny 10 micrograms concentrate for solution for infusion.
Korjuny 50 micrograms concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion (sterile concentrate). Clear and colourless solution. |
One pre-filled syringe contains 10 micrograms of catumaxomab* in 0.1 mL solution, corresponding to 0.1 mg/mL.
* rat-mouse hybrid IgG2 monoclonal antibody produced in a rat-mouse hybrid-hybridoma cell line
Excipients with known effect:
One pre-filled syringe contains 21.6 micrograms of polysorbate 80.
For the full list of excipients, see section 6.1.
One pre-filled syringe contains 50 micrograms of catumaxomab* in 0.5 mL solution, corresponding to 0.1 mg/mL.
* rat-mouse hybrid IgG2 monoclonal antibody produced in a rat-mouse hybrid-hybridoma cell line
Excipients with known effect:
One pre-filled syringe contains 108 micrograms of polysorbate 80.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Catumaxomab |
Catumaxomab is a trifunctional rat-mouse hybrid monoclonal antibody that is specifically directed against the epithelial cell adhesion molecule (EpCAM) and the CD3 antigen. The EpCAM antigen is expressed on most cancers especially carcinomas. CD3 is expressed on mature T-cells as a component of the T-cell receptor. A third functional binding site in the Fc-region of catumaxomab enables interaction with accessory immune cells via Fc-gamma receptors. |
| List of Excipients |
|---|
|
Sodium citrate (E331) |
Pre-filled syringe (type I glass, siliconised) with plunger stopper (bromobutyl rubber) and luer lock system (polypropylene siliconised and polycarbonate), with tip cap (bromobutyl rubber). A cannula is enclosed.
Korjuny 10 micrograms concentrate for solution for infusion:
The pre-filled syringe contains 0.1 mL concentrate for solution and is packed in a carton with a blue colour code.
Pack size: 3 pre-filled syringes and 5 cannulas.
Korjuny 50 micrograms concentrate for solution for infusion:
The pre-filled syringe contains 0.5 mL concentrate for solution and is packed in a carton with a red colour code.
Pack size: 4 pre-filled syringes and 5 cannulas.
Not all pack sizes may be marketed.
Lindis Biotech GmbH, Zeppelinstraße 4, 82178 Puchheim, Germany
EU/1/24/1826/001
EU/1/24/1826/002
| Drug | Countries | |
|---|---|---|
| KORJUNY | Lithuania |
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