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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: 19/04/2012
SPC Inactivated Influenza Vaccine (Split Virion) BP

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 19/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   29-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Core SmPC changes
Updated on 16/08/2011 and displayed until 19/04/2012
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   21-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
change of the annual year of the strain
Updated on 16/05/2011 and displayed until 16/08/2011
Reasons for adding or updating:
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

New plungestopper
Updated on 10/08/2010 and displayed until 16/05/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   29-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to flu strain
Updated on 29/07/2010 and displayed until 10/08/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   22-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Annual strain change
Updated on 19/07/2010 and displayed until 29/07/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


re-wording of section 4.3

Section 6.6 moving place of a senctence.
Updated on 14/08/2009 and displayed until 19/07/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   06-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2- Influenza strains updated
Updated on 23/06/2009 and displayed until 14/08/2009
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Flu strains for season 2008/09
Section 6.5: Removal of following: ‘and a tip cap (chlorobromobutyl)’

Section 6.6: Addition of sentence ‘The vaccine should not be used if foreign particles are present in the suspension’
Updated on 29/08/2008 and displayed until 23/06/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • SPC Retired pending re-submission
Date of revision of text on the SPC:   01-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Revision due to annual strain change.

Section 2

Strain changes

Season detail changes
Updated on 08/08/2008 and displayed until 29/08/2008
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   30-Dec-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 9 (Date of first authorisation/renewal of the authorisation), has been updated to reflect renewal on 30 December 2007
Updated on 17/08/2007 and displayed until 08/08/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - updated to include the strains recommended by the WHO for 2007-2008.
Updated on 18/09/2006 and displayed until 17/08/2007
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) 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
Section 2 - updated to include the strains recommended by the WHO for 2006-2007.
 
Section 4.8 - updated to include angiodema.
 
Section 10 - updated date of revision of text.
Updated on 09/09/2005 and displayed until 18/09/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • 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 09/09/2005
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Addition of Legal Category
  • Addition of new strength
Updated on 25/09/2003 and displayed until 29/09/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
Updated on 25/09/2002 and displayed until 25/09/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Addition of new strength
Updated on 22/08/2001 and displayed until 25/09/2002
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

 
  influenza vaccine