Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Genzyme Europe BV Gooimeer 10 1411 DD Naarden Netherlands
MabCampath 30 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Colourless to slightly yellow concentrate. |
One ml contains 30 mg of alemtuzumab.
Each vial contains 30 mg of alemtuzumab.
Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52). The antibody is produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Alemtuzumab |
Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52) expressed primarily on the surface of normal and malignant peripheral blood B and T cell lymphocytes. Alemtuzumab acts through antibody-dependent cellular cytolysis and complement-mediated lysis following cell surface binding to CD52, a cell surface antigen present at high levels on T (CD3+) and B (CD19+) lymphocytes, and at lower levels on natural killer cells, monocytes, and macrophages. |
| List of Excipients |
|---|
|
Disodium edetate |
Clear type I glass vial, closed with a rubber stopper, containing 1 ml of concentrate.
Pack size: carton of 3 vials.
Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Netherlands
EU/1/01/193/002
Date of first authorisation: 06/07/2001
Date of latest renewal: 10/07/2011
| Drug | Countries | |
|---|---|---|
| MABCAMPATH | Canada, Japan, Turkey |
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