Summary of Product Characteristics
last updated on the eMC:
14/11/2008
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 14/11/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 01-Aug-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 9 (Renewal of the Authorisation) : the date has changed to "29 August 2008".
In section 10 (Date of revision of the text) : the date has changed to "August 2008".
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Updated on 18/09/2007 and displayed until 14/11/2008
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 11/09/2007 and displayed until 18/09/2007
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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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| Date of revision of text on the SPC: 09/2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 - Special warnings and precautions for use - Addition of the text 'Keep out of the reach of children'
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Updated on 07/09/2004 and displayed until 11/09/2007
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 03/08/2004 and displayed until 07/09/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 22/04/2004 and displayed until 03/08/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 23/09/2002 and displayed until 22/04/2004
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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 10 (date of (partial) revision of the text
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Updated on 17/09/2002 and displayed until 23/09/2002
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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 10 (date of (partial) revision of the text
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Updated on 19/07/2001 and displayed until 17/09/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 23/08/2000 and displayed until 19/07/2001
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Reasons for adding or updating:
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