Summary of Product Characteristics
last updated on the eMC:
08/07/2009
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 08/07/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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| Date of revision of text on the SPC: 01-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 8 (Marketing Authorisation Number) : Change to Marketing Authorisation Number.
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Updated on 11/09/2008 and displayed until 08/07/2009
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Reasons for adding or updating:
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SPC Retired pending re-submission
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Change to section 4.4 - Special warnings and precautions for Use
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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: 01-Jul-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.4 (Special warnings and precautions for use) : The following text has been added "Keep all medicines out of the reach of children"
In section 9 (Renewal of the authorisation) : The date has changed to "29 July 2008"
In section 10 (Date of revision of the text) : The date has changed to "July 2008"
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Updated on 26/01/2007 and displayed until 11/09/2008
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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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