ILARIS Powder for solution for injection (2020)
Active ingredients: Canacinumab
Product Name and Form
Ilaris 150 mg/ml solution for injection.
Solution for injection (injection).
The solution is clear to opalescent and colourless to slightly brownish yellow.
Qualitative and Quantitative Composition
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.
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.
Histidine hydrochloride monohydrate
Water for injections
Pack sizes and Marketing
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
Date of first authorisation: 23 October 2009
Date of latest renewal: 06 June 2019