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ILARIS Powder for solution for injection (2020)

Active ingredients: Canacinumab

Product Name and Form

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.

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.

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

Mannitol
Histidine
Histidine hydrochloride monohydrate
Polysorbate 80
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.

Marketing authorization holder
Authorization dates

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

Marketing authorization number:

EU/1/09/564/004