Summary of Product Characteristics
last updated on the eMC:
02/06/2011
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 02/06/2011 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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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 07-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Undesirable effects where the frequency was previously unknown have now been classified in the side-effect table
Shelf-life increased to 3 years
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Updated on 20/07/2010 and displayed until 02/06/2011
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 04-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The SPC was revised due to a Type IB variation (approval December 2009):
The scope of the variation was the extension of shelf-life to 30 months
The change affected section 6.3 only.
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Updated on 14/09/2009 and displayed until 20/07/2010
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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