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Sanofi Pasteur MSD Limited
Mallards Reach, Bridge Avenue, Maidenhead, Berkshire, SL6 1QP
Telephone: +44 (0)1628 785 291
Fax: +44 (0)1628 671 722
Medical Information Direct Line: +44 (0)1628 587 693
Medical Information e-mail: medinfo@spmsd.com
Medical Information Fax: +44 (0)1628 635 072

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: 22/05/2008
SPC REVAXIS

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 22/05/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • 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:   04/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1        

Minor amendment to international non proprietary name

Section 4.4     
Addition of warning regarding administration via IV or ID route.

Addition of warning regarding GBS and BN following previous vaccination with a tetanus    containing vaccine.
 
Section 4.8     
 
Addition of side effects
Updated on 25/04/2007 and displayed until 22/05/2008
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   05/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The black triangle has been removed.
Updated on 21/09/2005 and displayed until 25/04/2007
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 26/08/2005 and displayed until 21/09/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/08/2005 and displayed until 26/08/2005
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/09/2004 and displayed until 24/08/2005
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  diphtheria, tetanus and poliomyelitis