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Cimzia 200 mg solution for injection (2012)

Active ingredients: Certolizumab pegol

Product Name and Form

Cimzia 200 mg solution for injection.

Pharmaceutical form

Solution for injection in pre-filled syringe.

Clear to opalescent, colourless to yellow solution. The pH of the solution is approximately 4.7.

Qualitative and Quantitative Composition

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.

Chemical substance
Description
Certolizumab pegol

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.

List of excipients

Sodium acetate
Sodium chloride
Water for injections

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

UCB Pharma SA
Allée de la Recherche 60
B-1070 Bruxelles
Belgium

Date of first authorisation: 01 October 2009

Marketing authorization number:

EU/1/09/544/001-002