Summary of Product Characteristics
last updated on the eMC:
18/10/2011
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 18/10/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Nov-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change in the wroding of section 4.8, and addition of some undesirable effects.
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Updated on 18/01/2010 and displayed until 18/10/2011
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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: 01-Jul-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The brand name of the product has been updated to comply with current legislation; the pharmaceutical form ('medicated nail lacquer') has therefore been added to the product name.
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Updated on 01/05/2009 and displayed until 18/01/2010
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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-Nov-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 6.5 - the reference to cleansing swabs and nail files has been removed as these are no longer contained within the pack.
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Updated on 10/05/2007 and displayed until 01/05/2009
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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: 08/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update of section 6.1 - List of excipients
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Updated on 01/03/2007 and displayed until 10/05/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 4.8 - update of undesirble effects
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Updated on 06/09/2006 and displayed until 01/03/2007
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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 (partial) revision of the text
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 – Change of office address from Galderma House, Church Lane, Kings Langley, Herts, WD4 8JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS
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Updated on 24/05/2006 and displayed until 06/09/2006
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Reasons for adding or updating:
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