Summary of Product Characteristics
last updated on the eMC:
20/03/2009
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 20/03/2009 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: 09-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| License renewal & date of revision
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Updated on 10/03/2008 and displayed until 20/03/2009
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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: 02/2008 |
| 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 21/04/2005 and displayed until 10/03/2008
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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 28/09/2004 and displayed until 21/04/2005
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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 7 - Marketing Authorisation Holder
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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 24/08/2001 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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