Summary of Product Characteristics
last updated on the eMC:
14/03/2008
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 14/03/2008 and displayed until Current
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 25/09/2007 and displayed until 14/03/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 12/09/2006 and displayed until 25/09/2007
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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 (partial) revision of the text
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Reason for change: Variation to add a new fill volume:
10. DATE OF REVISION OF THE TEXT
October 200423/06/2006
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Updated on 20/01/2005 and displayed until 12/09/2006
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Updated on 11/11/2004 and displayed until 20/01/2005
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 25/09/2002 and displayed until 11/11/2004
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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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Updated on 19/09/2002 and displayed until 25/09/2002
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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 (partial) revision of the text
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Updated on 20/07/2001 and displayed until 19/09/2002
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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