Summary of Product Characteristics
last updated on the eMC:
21/06/2011
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 21/06/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 12-Apr-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1
Change from Tixylix Honey, Lemon & Glycerol Syrup to Tixylix Honey, Lemon & Glycerol Oral Solution
Section 4.8
Change of wording from ‘No adverse effects would be anticipated’ to ‘Immune system disorder: hypersensitivity reactions, including anaphylaxis’.
Section 10
Change of date from January 2010 to April 2011
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Updated on 13/05/2011 and displayed until 21/06/2011
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 12-Apr-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1
Change from Tixylix Honey, Lemon & Glycerol Syrup to Tixylix Honey, Lemon & Glycerol Oral Solution
Section 4.8
Change of wording from ‘Immune system disorder: hypersensitivity reactions, including anaphylaxis’ to ‘No adverse effects would be anticipated’.
Section 10
Change of date from January 2010 to April 2011
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Updated on 15/07/2010 and displayed until 13/05/2011
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Reasons for adding or updating:
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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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