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Genzyme Therapeutics

4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, Oxfordshire, OX4 2SU
Telephone: +44 (0)1865 405 200
Fax: +44 (0)1865 774 172
WWW: http://www.genzyme.co.uk
Medical Information Direct Line: +44 (0)1483 505 515
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com
Customer Care direct line: +44 (0)1865 405 200
Medical Information Fax: +44(0)1483 554 805

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: 11/05/2012
SPC Thymoglobuline 25 mg powder for solution for infusion

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
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:   28-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

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).
Updated on 08/12/2009 and displayed until 11/05/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
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

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.
Updated on 25/04/2008 and displayed until 08/12/2009
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
   rabbit anti-human thymocyte immunoglobulin