Summary of Product Characteristics
last updated on the eMC:
11/05/2011
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 11/05/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Apr-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| hypersensitivity reported to glycerin, change to 4.8
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Updated on 29/06/2010 and displayed until 11/05/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 01-Jan-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 2 - changed liquid sugar demin to liquid sugar$0Section 6.5 - Add a 100ml pack size$0
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Updated on 21/11/2002 and displayed until 29/06/2010
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Reasons for adding or updating:
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Change to section 1 - trade name
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Updated on 11/11/2002 and displayed until 21/11/2002
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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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