Summary of Product Characteristics
last updated on the eMC:
08/08/2011
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 08/08/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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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: 08-Jul-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.3 , the text 'Hypersensitivity to the active substance or any of the excipients' has been included.
In section 4.4, sucrose warnings have been included.
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Updated on 27/01/2011 and displayed until 08/08/2011
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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 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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| Date of revision of text on the SPC: 18-Jan-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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To update section 4.2 (Posology and method of administration) and 4.3 (Contraindications) of the SPC, to introduce a minimum age limit of 1 year on the product.
Glycerol, Honey, Citric acid monohydrate, Lemon oil terpeneless, Syrup list of actives had been neglected in line with the current MHRA approved version.
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Updated on 28/07/2010 and displayed until 27/01/2011
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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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