Summary of Product Characteristics
last updated on the eMC:
17/10/2011
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 17/10/2011 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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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 26-Jan-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 updated to include a warning regarding the levels of sucrose and glucose per lozenge, to update the warning 'Keep out of the reach and sight of children' and to add the statement 'Do not exceed the stated dose'
Section 4.8 updated to add local site irritation and inflammation in the mouth and throat as side effects
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Updated on 18/03/2009 and displayed until 17/10/2011
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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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| Date of revision of text on the SPC: |
| 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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