Summary of Product Characteristics
last updated on the eMC:
10/02/2010
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 10/02/2010 and displayed until Current
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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-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Date of Revisio of Text: August 2009
This has been amended to reflect that there were two separate updates - one in July 2009 reflecting the pack type and one in August 2009 regarding the storage condition.
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Updated on 03/08/2009 and displayed until 10/02/2010
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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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: 28-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 6.4 (Special precautions for storage), 'Do not store above 30C. Store in the original package' has been changed to 'Do not store above 25C'.
In section 10. Date of Revision of Text has been updated to July 2009.
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Updated on 28/07/2009 and displayed until 03/08/2009
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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 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 23-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.5 Nature and contents of container
White opaque PVC/PE/Aclar blister or white opaque PVC/Aclar/PVC blister with aluminium foil in packs of 28 tablets.
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Updated on 10/07/2009 and displayed until 28/07/2009
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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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: 07-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.4 Special precautions for storage
For blister packs
Do not store above 30°C. Store in the original package.
10. DATE OF (PARTIAL) REVISION OF TEXT
July 2009June 2008
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Updated on 23/07/2008 and displayed until 10/07/2009
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 02-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| No special precautions for storage
Do not store above 30°C. Store in the original package.
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Updated on 26/10/2005 and displayed until 23/07/2008
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 26/10/2005 and displayed until 26/10/2005
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 14/09/2005 and displayed until 26/10/2005
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 30/08/2002 and displayed until 14/09/2005
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Updated on 29/05/2002 and displayed until 30/08/2002
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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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