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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: 01/07/2010
SPC Inactivated Influenza Vaccine (Split Virion) BP

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 01/07/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


section 4.3 - rewording of the section

6.6 moving the place of a sentence

updating the authorisation year so it matches IE
Updated on 24/08/2009 and displayed until 01/07/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10-Aug-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
In Section 2, the Influenza strains have been changed.

Date of revision of the text has changed
Updated on 06/07/2009 and displayed until 24/08/2009
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
Date of revision of text on the SPC:   01-May-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

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 25/10/2005 and displayed until 06/07/2009
Reasons for adding or updating:
  • New SPC for medicines.ie

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