Summary of Product Characteristics
last updated on the eMC:
22/09/2010
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 22/09/2010 and displayed until Current
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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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| Date of revision of text on the SPC: 12-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change is to the title as SPC appears on eMC to reflect new name of product. The SPC itself has not changed since last revision.
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Updated on 17/08/2010 and displayed until 22/09/2010
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 12-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Sections 1 and 2 updated in line with NPSA guidance. Section 10 - new date of revision.
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Updated on 17/09/2007 and displayed until 17/08/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 (Marketing Authorisation Holder): Change to MA Holder's details
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Updated on 20/09/2006 and displayed until 17/09/2007
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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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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of active ingredient from BP to EUR
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Updated on 10/08/2006 and displayed until 20/09/2006
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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| Date of revision of text on the SPC: 12/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of marketing authorisation holder
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