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Ilaris 150mg powder for solution for injection (2011)

Active ingredients: Canacinumab

Product Name and Form

Ilaris 150 mg powder for solution for injection.

Pharmaceutical form

Powder for solution for injection.

The powder is white.

Qualitative and Quantitative Composition

One vial contains 150 mg of canakinumab*.

After reconstitution, each ml of solution contains 150 mg canakinumab.

* fully human monoclonal antibody produced in mouse hybridoma Sp2/0 cells by recombinant DNA technology

For a full list of excipients, see section 6.1.

Chemical substance
Description
Canacinumab

Canakinumab is a human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/κ isotype. Canakinumab binds with high affinity specifically to human IL-1 beta and neutralises the biological activity of human IL-1 beta by blocking its interaction with IL-1 receptors, thereby preventing IL-1 beta-induced gene activation and the production of inflammatory mediators.

List of excipients

Sucrose
Histidine
Histidine hydrochloride monohydrate
Polysorbate 80

Pack sizes and Marketing

150 mg of powder for solution for injection in a vial (type I glass) with a stopper (coated chlorobutyl rubber) and flip-off cap (aluminium).

Packs containing 1 vial or multipacks containing 4 (4x1) vials.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom

23.10.2009

Marketing authorization number:

EU/1/09/564/001-002