Summary of Product Characteristics
last updated on the eMC:
15/12/2010
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 15/12/2010 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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| Date of revision of text on the SPC: 01-Mar-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 9 (Renewal of Authorisation) the date has changed to "7 December 2010"
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Updated on 14/08/2008 and displayed until 15/12/2010
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 date of revision of the text
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 01-Mar-2008 |
| Legal Category: GSL |
| 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: "Because it contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine".
In section 6.5 (nature and contents of container) : The following text has been deleted: "This is supplied as an original pack (OP)".
In section 10 (date of revision of the text) : The date has changed to "March 2008".
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Updated on 26/01/2007 and displayed until 14/08/2008
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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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