Summary of Product Characteristics
last updated on the eMC:
21/03/2012
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 21/03/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 01-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Shelf Life changed from 18 months to 24 months
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Updated on 16/04/2010 and displayed until 21/03/2012
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 01-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| - in section 4.2 new information about booster doses is now added
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Updated on 20/08/2009 and displayed until 16/04/2010
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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 8 - MARKETING AUTHORISATION NUMBER(S)
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| Date of revision of text on the SPC: 01-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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- In section 6.5 , the availability of the suspension with AND without a needle has been clarified
- In section 8, two marketing authorisation numbers are now included which incorporate a reference to the suspension being available either with or without a needle
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Updated on 08/05/2009 and displayed until 20/08/2009
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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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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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