Ilaris 150mg powder for solution for injection

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.

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

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

Marketing authorization dates and numbers

EU/1/09/564/001-002

23.10.2009

Drugs

Drug
Countries
Austria, Brazil, Canada, Cyprus, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States, South Africa