Summary of Product Characteristics
last updated on the eMC:
11/05/2012
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 11/05/2012 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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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 28-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Type IB variation to update sections 4.4 and 4.8 of the SPC and PIL in line with the agreed CSP following the finalisation of the EU PSUR work-sharing procedure EE/H/PSUR/0008/001 on 14 September 2011 (UK/H/2959/01/IB/46).
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Updated on 08/12/2009 and displayed until 11/05/2012
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 12-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Changes to sections 4.4 and 10
Section 4.4 - Special Warnings and Precautions for use: Addition of paragraphs indicating that Thymoglobuline should be used under strict medical supervision in hospital settings.
Section 4.4 - Special Warnings and Precautions for use: Addition of paragraphs regarding information on the Risk of Transmission of Infectious Agents.
Section 10 - Date of Revision of the Text: Change in date.
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Updated on 25/04/2008 and displayed until 08/12/2009
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Reasons for adding or updating:
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