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MabCampath 30mg/ml concentrate for solution for infusion (2012)

Active ingredients: Alemtuzumab

Product Name and Form

MabCampath 30 mg/ml concentrate for solution for infusion.

Pharmaceutical form

Concentrate for solution for infusion.

Colourless to slightly yellow concentrate.

Qualitative and Quantitative Composition

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.

Chemical substance
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
Polysorbate 80
Potassium chloride
Potassium dihydrogen phosphate
Sodium chloride
Dibasic sodium phosphate
Water for injections

Pack sizes and Marketing

Clear type I glass vial, closed with a rubber stopper, containing 1 ml of concentrate.

Pack size: carton of 3 vials.

Marketing authorization holder
Authorization dates

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Netherlands

Date of first authorisation: 06/07/2001

Date of latest renewal: 10/07/2011

Marketing authorization number:

EU/1/01/193/002