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UCB Pharma Limited

208 Bath Road, Slough, Berkshire, SL1 3WE
Telephone: +44 (0)1753 534 655
Medical Information Direct Line: +44 (0)1753 447 690
Medical Information e-mail: Medicalinformationuk@ucb.com
Customer Care direct line: +44 (0) 1773 510123

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 17/01/2012
SPC Cimzia 200 mg solution for injection

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 17/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   21-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

In section 4.4 (special warnings and precautions for use) : a line has been added "to test the patients for HBV infection before initiating treatment with cimzia."
Updated on 07/10/2011 and displayed until 17/01/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   02-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

The name of the table has been updated with the addition of wording Post marketing.

Table-1 in Section 4.8 has been updated
Updated on 24/09/2010 and displayed until 07/10/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   27-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 4.4 - Addition of FDA class warning for TNF antagonists of risk of lymphoma leukaemia and malignancies.

Section 4.8 - Removal of lymphoma as rare side effect - replaced with blood and lymphatic systems malignancies.
Updated on 12/10/2009 and displayed until 24/09/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

None provided

Active Ingredients/Generics

 
   certolizumab pegol