Updated on 16/08/2011 and displayed until Current
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Reasons for adding or updating:
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-
Change to section 2 - Qualitative and quantitative composition
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| 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
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| change of the annual year of the strain
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Updated on 16/05/2011 and displayed until 16/08/2011
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Reasons for adding or updating:
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-
Change to section 6. 6 - Instructions for use, handling and disposal
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| 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
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| New plungestopper
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Updated on 10/08/2010 and displayed until 16/05/2011
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Reasons for adding or updating:
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-
Change to section 2 - Qualitative and quantitative composition
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| 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
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Change to flu strain
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Updated on 29/07/2010 and displayed until 10/08/2010
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Reasons for adding or updating:
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-
Change to section 2 - Qualitative and quantitative composition
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| 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
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| Annual strain change
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Updated on 19/07/2010 and displayed until 29/07/2010
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Reasons for adding or updating:
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-
Change to section 2 - Qualitative and quantitative composition
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Change to section 4.3 - Contraindications
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| 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.
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Updated on 14/08/2009 and displayed until 19/07/2010
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Reasons for adding or updating:
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-
Change to section 2 - Qualitative and quantitative composition
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| 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
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| Section 2- Influenza strains updated
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Updated on 23/06/2009 and displayed until 14/08/2009
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Reasons for adding or updating:
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-
Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instructions for use, handling and disposal
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| 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’
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Updated on 29/08/2008 and displayed until 23/06/2009
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Reasons for adding or updating:
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-
Change to section 2 - Qualitative and quantitative composition
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SPC Retired pending re-submission
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| 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
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| Revision due to annual strain change.
Section 2
Strain changes
Season detail changes
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Updated on 08/08/2008 and displayed until 29/08/2008
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Reasons for adding or updating:
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-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| 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
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Updated on 17/08/2007 and displayed until 08/08/2008
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Reasons for adding or updating:
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-
Change to section 2 - Qualitative and quantitative composition
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| 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.
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Updated on 18/09/2006 and displayed until 17/08/2007
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Reasons for adding or updating:
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-
Change to section 2 - qualitative and quantitative composition
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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| 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.
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Updated on 09/09/2005 and displayed until 18/09/2006
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Reasons for adding or updating:
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-
Change to section 2 - qualitative and quantitative composition
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 29/09/2004 and displayed until 09/09/2005
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Reasons for adding or updating:
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-
Change to section 2 - qualitative and quantitative composition
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Addition of Legal Category
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Addition of new strength
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Updated on 25/09/2003 and displayed until 29/09/2004
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Reasons for adding or updating:
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-
Change to section 2 - qualitative and quantitative composition
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Updated on 25/09/2002 and displayed until 25/09/2003
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Reasons for adding or updating:
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-
Correction of spelling/typing errors
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Addition of new strength
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Updated on 22/08/2001 and displayed until 25/09/2002
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Reasons for adding or updating:
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-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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