Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Ilaris 150 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). The solution is clear to opalescent and colourless to slightly brownish yellow. |
One vial contains 150 mg of canakinumab*.
Each ml of solution contains 150 mg canakinumab.
* human monoclonal antibody produced in mouse myeloma Sp2/0 cells by recombinant DNA technology
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Canacinumab |
Canacinumab is a human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/Îș 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 |
|---|
|
Mannitol |
Solution for injection in a vial (type I glass) with a stopper (laminated chlorobutyl rubber) and flip-off cap (aluminium).
Packs containing 1 vial.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/09/564/004
Date of first authorisation: 23 October 2009
Date of latest renewal: 06 June 2019
| 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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