Summary of Product Characteristics
last updated on the eMC:
24/09/2008
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 24/09/2008 and displayed until Current
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 4.3 - Contraindications
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 03-Jan-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Completely updated version of SmPC reflecting changes to sections 4.3, 4.5 and 4.8 as well as change in MAH and update of format to QRD template.
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Updated on 12/09/2005 and displayed until 24/09/2008
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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 25/02/2003 and displayed until 12/09/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 29/08/2001 and displayed until 25/02/2003
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 29/08/2001
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Reasons for adding or updating:
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