Summary of Product Characteristics
last updated on the eMC:
21/12/2009
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 21/12/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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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: 02-Dec-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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To register an additional name on the licence
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Updated on 03/04/2008 and displayed until 21/12/2009
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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: 03/2008 |
| Legal Category: P |
| 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 13/12/2007 and displayed until 03/04/2008
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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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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 6.5: Nature and Contents of container
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Updated on 14/09/2006 and displayed until 13/12/2007
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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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| Date of revision of text on the SPC: 07/2005 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10 Change in date of revision of text
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Updated on 28/09/2004 and displayed until 14/09/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 19/09/2002 and displayed until 28/09/2004
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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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Change to section 7 - Marketing Authorisation Holder
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Updated on 24/08/2001 and displayed until 19/09/2002
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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