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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: 29/11/2011
SPC ViATIM

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 29/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 4.2 there has been an inclusion of long term immunity
In section 5.1 there has been an insertion of serological data
Updated on 04/12/2009 and displayed until 29/11/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.8 - Undesirable effects

Update to mention both anaphylactic and anaphylactoid reactions (including shock) as immune system disorders

Change to section 10 – Date of partial revision of the text.

09/2009
Updated on 18/01/2007 and displayed until 04/12/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Sections 1-10:  Removal of ® symbol in line with QRD template.

 

Sections 4.3, 4.6, 4.7, 4.8, 5.3, 6.4, and 6.5: Updated in line with QRD template
 
Section 4.8:  Corrected ‘Uncommon (>1000)’ to ‘Uncommon (>1/1000)’

Sections 9 and 10:  Changed to 02/09/2006
Updated on 12/01/2007 and displayed until 18/01/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 1-10: Removal of ® symbol in line with QRD template.
 
Sections 4.3, 4.6, 4.7, 4.8, 5.3, 6.4 and 6.6: Updated in line with QRD template.
 
Sections 9 and 10: Changed to 02/09/2006
Updated on 21/09/2005 and displayed until 12/01/2007
Reasons for adding or updating:
  • 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 21/09/2005
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Updated on 27/09/2002 and displayed until 29/09/2004
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 07/08/2002 and displayed until 27/09/2002
Reasons for adding or updating:
  • New SPC for new product

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