Summary of Product Characteristics
last updated on the eMC:
14/10/2009
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 14/10/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 14-Aug-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To register a reduction of caramel E150 from 0.10% w/w to 0.07% w/w, to compensate this loss the amount of Purified Water BP has increased from 43.31% w/w to 43.34% w/w. Consequentially section 6.1 of the SPC has been updated to reflect the change.
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Updated on 18/08/2009 and displayed until 14/10/2009
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 26-Nov-2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.1 updated to include excipient composition.
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Updated on 28/07/2009 and displayed until 18/08/2009
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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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