Cimzia

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certolizumab pegol

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 15 November 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product CIMZIA 200 mg powder and solvent for solution for injection, intended for the treatment of severe, active Crohn’s disease. The company that applied for authorisation is UCB Pharma SA.

The applicant requested a re-examination of the opinion. After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the recommendation for the refusal of the marketing authorisation on 19 March 2008.

This EPAR was last updated on 20/03/2008

Application details

Product details
Name
Cimzia
Active substance
Certolizumab pegol
International non-proprietary name (INN) or common name
certolizumab pegol
Therapeutic area (MeSH)
Crohn Disease
Anatomical therapeutic chemical (ATC) code
L04AB05
Application details
Marketing-autorisation applicant
UCB Pharma SA
Date of opinion
19/03/2008
Date of refusal of marketing authorisation
21/05/2008

Assessment history

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