Summary of Product Characteristics
last updated on the eMC:
13/03/2009
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 13/03/2009 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: 27-Feb-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Nature of change: Renewal of product licence. No changes to artwork as a result of this renewal. The SPC has been updated to reflect this renewal date and date of revision.
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Updated on 19/05/2008 and displayed until 13/03/2009
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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: 11-Apr-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 26/08/2005 and displayed until 19/05/2008
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Reasons for adding or updating:
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 24/08/2005 and displayed until 26/08/2005
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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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