Summary of Product Characteristics
last updated on the eMC:
06/08/2009
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 06/08/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to Section 7. Marketing Authorisation Holder
Change to Section 10. Date of Revision of Text
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Updated on 30/04/2009 and displayed until 06/08/2009
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Reasons for adding or updating:
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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-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 10. Date of revision of text
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Updated on 05/12/2007 and displayed until 30/04/2009
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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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| Date of revision of text on the SPC: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| There has been a change to the composition of the registered blister packs from PVDC to PVC/Aluminium and registered blister packs containing 30 tablets
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Updated on 07/06/2007 and displayed until 05/12/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 05/08/2005 and displayed until 07/06/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 02/08/2005 and displayed until 05/08/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Pending awaiting re-submission
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Updated on 01/08/2005 and displayed until 02/08/2005
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Reasons for adding or updating:
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Change to section 1 - trade name
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Pending awaiting re-submission
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Updated on 22/03/2005 and displayed until 01/08/2005
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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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