Summary of Product Characteristics
last updated on the eMC:
15/02/2012
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 15/02/2012 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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| Date of revision of text on the SPC: 01-Feb-2012 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 6.5 the pack size of 10g has been removed.
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Updated on 23/06/2011 and displayed until 15/02/2012
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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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| Date of revision of text on the SPC: 20-Nov-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The excipient 'Anise Oil' has been corrected to 'Mint Flavour' in Section 6.1 (List of excipients)
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Updated on 01/12/2010 and displayed until 23/06/2011
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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: 20-Nov-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- In section 6.3, shelf life has been changed from 3 to 2 years.
- In section 6.4, storage condition has been changed from ‘no special precautions for storage’ to ‘Do not store above 25° C’
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Updated on 27/07/2010 and displayed until 01/12/2010
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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: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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