Summary of Product Characteristics
last updated on the eMC:
06/08/2010
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 06/08/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 6.3 (Shelf life) the following text has been added: "Discard 4 weeks after first opening."
In section 9 (Renewal of the authorisation) the date has changed to "24 June 2007."
In section 10 (Date of revision of the text) the date has changed to "July 2010."
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Updated on 26/01/2007 and displayed until 06/08/2010
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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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