Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Neovii Biotech GmbH, Am Haag 6-7, 82166 Graefelfing, Germany
Removab 10 micrograms concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. 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
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 overexpressed on most carcinomas. Due to catumaxomab’s binding properties, a concerted immunoreaction against tumour cells is induced which includes different mechanisms of action, resulting in destruction of tumour cells. |
| List of Excipients |
|---|
|
Sodium citrate |
0.1 ml concentrate for solution for infusion in a pre-filled syringe (type I glass, siliconised) with plunger stopper (bromobutyl rubber) and luer lock system (polypropylene siliconised and polycarbonate) with tip cap (styrene butadiene rubber) with a cannula; pack size of 1.
Neovii Biotech GmbH, Am Haag 6-7, 82166 Graefelfing, Germany
EU/1/09/512/001
Date of first authorisation: 20 April 2009
Date of latest renewal: 18 December 2013
| Drug | Countries | |
|---|---|---|
| REMOVAB | Estonia, Lithuania |
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