Summary of Product Characteristics
last updated on the eMC:
07/08/2009
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 07/08/2009 and displayed until Current
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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 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 31-Jul-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Reason for change:
To remove reference to 'child resistant tear through' and 'rectangular shaped blisters' from section 6.5 of the SPC.
Update of SPC section 6.6 to include waste disposal statement
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Updated on 17/04/2008 and displayed until 07/08/2009
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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: 01/2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to MA as a result of integration
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Updated on 05/02/2008 and displayed until 17/04/2008
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Reasons for adding or updating:
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