Summary of Product Characteristics
last updated on the eMC:
13/05/2011
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 13/05/2011 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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Change in co-marketing arrangement
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| Date of revision of text on the SPC: 20-Apr-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10
Change of date from 27 April 2009 to 20 April 2011
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Updated on 20/05/2009 and displayed until 13/05/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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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: 27-Apr-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4
Addition of the words :
‘In case of accidental contact with the eyes, rinse the eyes thoroughly with running water.’
Section 4.6
Addition of the words :
‘Infants should also not be allowed to come into contact with any treated skin, including the breast.’
Section 10
Date change from 10 February 2009 to 27 April 2009
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Updated on 01/08/2008 and displayed until 20/05/2009
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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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