Summary of Product Characteristics
last updated on the eMC:
29/06/2009
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 29/06/2009 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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| Date of revision of text on the SPC: 16-Jun-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Inclusion of additional name to existing PL.
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Updated on 08/06/2009 and displayed until 29/06/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 16-Jun-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 7 MAH change to address details.
In section 10 revision date update.
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Updated on 17/05/2005 and displayed until 08/06/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 07/10/2003 and displayed until 17/05/2005
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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 07/10/2003
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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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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