Summary of Product Characteristics
last updated on the eMC:
28/03/2012
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 28/03/2012 and displayed until Current
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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: 09-Mar-2012 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.4
Change from Store below 30°C to Store below 25°C.
Section 10
Date change from 5 January 2012 to 9 March 2012
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Updated on 10/01/2012 and displayed until 28/03/2012
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 05-Jan-2012 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.3
Change from 36 months to 24 months.
Section 10
Date change from 18 August 2010 to 5 January 2012
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Updated on 20/08/2010 and displayed until 10/01/2012
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 18-Aug-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5
Delete: Polyethylene/aluminium/polyethylene laminate tube with screw cap
Addition: Polyethylene/aluminium/polyethylene laminate tube with a multi-layer peel-off tamper evident seal composed of lacquer, aluminium and internal ionomer, closed screw cap.
Section 10
Date change from 12 July 2006 to 18 August 2010.
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Updated on 04/08/2008 and displayed until 20/08/2010
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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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