Summary of Product Characteristics
last updated on the eMC:
09/09/2009
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 09/09/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 10 date of revision of the text
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 01-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- section 2...the strains are revised to take account of those recommended for the 2009/2010 flu season
- in sections 4.1 - 4.6,,,,,the new season (Begrivac 2009/2010) replaces the previous season (2009/2009)
- section 10 provides the date of the latest revision of the text
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Updated on 27/08/2008 and displayed until 09/09/2009
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- In section 2 (qualitative and quanititative composition), antigens updated for 2008-2009 season
- In section 10 (date of partial revision of the text), date updated to incorporate new antigen strains for 2008-2009 season
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Updated on 05/11/2007 and displayed until 27/08/2008
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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section 1: update vaccine season to 2007/2008
Section 2 : update composition of viral strains of influenza vaccine to 2007/2008 season
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Updated on 25/10/2006 and displayed until 05/11/2007
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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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