Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
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. |
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 |
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 |
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
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
| Drug | Countries | |
|---|---|---|
| CIMZIA | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Tunisia, Turkey, United Kingdom, United States |
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