Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom
Ilaris 150 mg powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection. The powder is white. |
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.
| Active Ingredient |
|---|
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Canacinumab is a human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/κ isotype. Canacinumab 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 |
|---|
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Sucrose |
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.
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom
EU/1/09/564/001-002
23.10.2009
| Drug | Countries | |
|---|---|---|
| ILARIS | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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