Summary of Product Characteristics
last updated on the eMC:
13/02/2012
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 13/02/2012 and displayed until Current
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Reasons for adding or updating:
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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: 05-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.4 (Special Warnings and Special Precautions for Use), a standard warning for sugar intolerance has been added.
Patients with rare hereditary problems of fructose intorlerances, glucose-galactose malabsorption or sucrase-isomaltese insufficiency should not take this medicine.
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Updated on 25/11/2009 and displayed until 13/02/2012
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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: 18-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to address of MAH from Benham Valence to Park View House.
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Updated on 07/09/2009 and displayed until 25/11/2009
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Reasons for adding or updating:
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Improved Electronic Presentation
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| Date of revision of text on the SPC: 19-Feb-2009 |
| Legal Category: POM |
| 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 30/09/2005 and displayed until 07/09/2009
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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 12/12/2003 and displayed until 30/09/2005
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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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