Summary of Product Characteristics
last updated on the eMC:
03/04/2008
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 03/04/2008 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: 03/2008 |
| Legal Category: GSL/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 03/04/2008 and displayed until 03/04/2008
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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: 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 13/09/2006 and displayed until 03/04/2008
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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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| Date of revision of text on the SPC: 02/2005 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10 Change to date of revision of text
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Updated on 14/09/2005 and displayed until 13/09/2006
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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 09/09/2005 and displayed until 14/09/2005
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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 08/09/2005 and displayed until 09/09/2005
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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 28/09/2004 and displayed until 08/09/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 16/01/2004 and displayed until 28/09/2004
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 26/09/2002 and displayed until 16/01/2004
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 16/09/2002 and displayed until 26/09/2002
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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 28/08/2001 and displayed until 16/09/2002
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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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