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LEMTRADA Concentrate for solution for infusion (2020)

Active ingredients: Alemtuzumab

Product Name and Form

LEMTRADA 12 mg concentrate for solution for infusion.

Pharmaceutical form

Concentrate for solution for infusion (sterile concentrate).

A clear, colourless to slightly yellow concentrate with pH 7.0–7.4.

Qualitative and Quantitative Composition

Each vial contains 12 mg alemtuzumab in 1.2 ml (10 mg/ml).

Alemtuzumab is a monoclonal antibody produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium by recombinant DNA technology.

Excipients with known effect:

This medicine contains less than 1 mmol potassium (39 mg) per infusion, i.e. it is essentially ‘potassium-free’.

This medicine contains less than 1 mmol sodium (23 mg) per infusion, i.e. it is essentially ‘sodium-free’.

For the 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 phosphate dihydrate (E339)
Disodium edetate
Potassium chloride (E508)
Potassium dihydrogen phosphate (E340)
Polysorbate 80 (E433)
Sodium chloride
Water for injections

Pack sizes and Marketing

LEMTRADA is supplied in a clear, 2 ml glass vial, with a butyl rubber stopper and aluminium seal with a plastic flip-off cap.

Pack size: carton with 1 vial

Marketing authorization holder
Authorization dates

Sanofi Belgium, Leonardo Da Vincilaan 19, B-1831, Diegem, Belgium

Date of first authorisation: 12 September 2013

Date of latest renewal: 2 July 2018

Marketing authorization number:

EU/1/13/869/001