Active ingredients: Certolizumab pegol
Cimzia 200 mg solution for injection in pre-filled syringe.
Solution for injection (injection).
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.
Certolizumab pegol has a high affinity for human TNFα and binds with a dissociation constant (KD) of 90 pM. TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes. Certolizumab pegol was shown to neutralise membrane associated and soluble human TNFα in a dose-dependent manner. By inhibiting the action of TNFα, certolizumab pegol reduces inflammation and other symptoms in patients with rheumatoid arthritis.
Water for injections
One ml pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol. The needle shield is styrene butadiene rubber which contains a derivative of natural rubber latex (see section 4.4).
Pack size of 2 pre-filled syringes and 2 alcohol wipes.
Multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes.
Multipack containing 10 (5 packs of 2) pre-filled syringes and 10 (5 packs of 2) alcohol wipes.
Pack size of 2 pre-filled syringes with needle guard and 2 alcohol wipes (for use by healthcare professionals only).
Not all pack sizes may be marketed.
UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
Date of first authorisation: 01 October 2009
Date of latest renewal: 16 May 2014