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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: 13/06/2011
SPC TYPHIM Vi

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 13/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.5 Nature and contents of container has changed to include bromobutyl or chlorobutyl
In section 10 date of revision of text has changed to 7th April 2011 
Updated on 13/06/2011 and displayed until 13/06/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 6.5 (nature and contents of container), bromobutyl & chlorobutyl have been added
In section 10 (date of revision of the text), the date 27th January 2011 has been added replacing the last revised date
Updated on 15/09/2009 and displayed until 13/06/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 4.8 (undesirable effects) - Data from post marketing experience, immune system disorders.  Update of Anaphylactoid reactions to Anaphylactic/anaphylactoid reactions, including shock

Updated on 14/11/2007 and displayed until 15/09/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 1 – Updated generic name (Typhoid Polysaccharide Vaccine) in line with Ph. Eur

 

Section 3 – Updated in line with current guidance

 

Section 4.1 – Increased age of indication in children to 2 years.

 

Section 4.2 - Increased age of indication in children to 2 years.

 

Section 4.4 – Updated to include warning on administration to people who are: allergic to formaldehyde, immunosuppressed, or have a bleeding disorder.

 

Section 4.5 – Updated to include list of vaccines that can administered concomitantly with Typhim Vi®.

 

Section 4.7 – Updated to include warning on tiredness.

Section 4.8 - Updated in line with current guidance.

 

Section 6.1 – Updated in line with Ph.Eur.

 

Section 6.4 – An instruction to keep the syringe in the carton has been added.
Updated on 04/09/2006 and displayed until 14/11/2007
Reasons for adding or updating:
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   03/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
  • Section 6.5 - updated to include the addition of a prefilled syringe presentation with 1 or 2 separate needles.
  • Section 6.6 - sentence added to describe needle attachment.
  • Section 10 - update to date of revision of the text.
Updated on 30/08/2005 and displayed until 04/09/2006
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 30/08/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Addition of Legal Category
Updated on 25/09/2003 and displayed until 29/09/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 23/08/2001 and displayed until 25/09/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  typhoid vaccine