Summary of Product Characteristics
last updated on the eMC:
29/07/2010
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 29/07/2010 and displayed until Current
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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: 07-Jul-2010 |
| 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 5 years to 3 years.
Section 10
Date change from 30 June 2009 to 7 July 2010
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Updated on 09/03/2010 and displayed until 29/07/2010
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 30-Jun-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5
Change of wording from Amber glass bottle with wadless polypropylene cap in cardboard carton to Amber glass bottle with a tamper evident cap made of polypropylene in cardboard carton.
Section 10
Date of revision changed to 30 June 2009
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Updated on 28/09/2007 and displayed until 09/03/2010
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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