Summary of Product Characteristics
last updated on the eMC:
17/01/2012
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
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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| 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
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| 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."
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Updated on 07/10/2011 and displayed until 17/01/2012
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| 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
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The name of the table has been updated with the addition of wording Post marketing.
Table-1 in Section 4.8 has been updated
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Updated on 24/09/2010 and displayed until 07/10/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| 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
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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.
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Updated on 12/10/2009 and displayed until 24/09/2010
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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