CIMZIA Solution for injection

Active ingredients: Certolizumab pegol

Product name and form

Cimzia 200 mg solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection (injection).

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.

Active Ingredient
Description

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. 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.

Marketing authorization holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium

Marketing authorization dates and numbers

EU/1/09/544/001
EU/1/09/544/002
EU/1/09/544/003
EU/1/09/544/004

Date of first authorisation: 01 October 2009

Date of latest renewal: 16 May 2014

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, Poland, Tunisia, United Kingdom, United States