go to medicines.ie homepage
Font Size
Search for:  
select
  Advanced Search

Sanofi Pasteur MSD Limited
Block A, Second Floor, Cookstown Court, Old Belgard Road, Tallaght, Dublin 24,
Telephone: +353 1 468 5600
Fax: +353 1 420 3588
Medical Information Direct Line: +44 (0)1628 587 693
Medical Information e-mail: medinfo@spmsd.com
Medical Information Facsimile: +44 (0)1628 635 072
Summary of Product Characteristics last updated on medicines.ie: 17/04/2008
SPC REVAXIS

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

Updated on 17/04/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of 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:   prescription only

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 24/04/2007 and displayed until 17/04/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 7 - updated the address of the Marketing Authorisation Holder.

Section 10 - changed date of revision to March 2007
Updated on 10/08/2005 and displayed until 24/04/2007
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Updated on 06/08/2004 and displayed until 10/08/2005
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 23/06/2003 and displayed until 06/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share