Summary of Product Characteristics
last updated on the eMC:
17/04/2008
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 17/04/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 01/2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to MA as a result of integration.
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Updated on 30/11/2005 and displayed until 17/04/2008
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Updated on 28/09/2005 and displayed until 30/11/2005
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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 13/09/2005 and displayed until 28/09/2005
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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 30/09/2004 and displayed until 13/09/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 16/08/2002 and displayed until 30/09/2004
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 07/08/2001 and displayed until 16/08/2002
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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