Cimzia 200 mg solution for injection.
Solution for injection in pre-filled syringe.
Clear to opalescent, colourless to yellow solution. The pH of the solution is approximately 4.7.
Each pre-filled syringe contains 200 mg certolizumab pegol in one ml.
Certolizumab pegol is a recombinant, humanised antibody Fab' fragment against tumour necrosis factor alpha (TNFα) expressed in Escherichia coli and conjugated to polyethylene glycol (PEG).
For the full list of excipients, see section 6.1.
Water for injections
One ml pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol.
None of the components of the syringe contain latex.
Pack size of 2 syringes and 2 alcohol wipes, and multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes.
Not all pack sizes may be marketed.
UCB Pharma SA
Allée de la Recherche 60
Date of first authorisation: 01 October 2009