Summary of Product Characteristics
last updated on the eMC:
24/11/2010
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 24/11/2010 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 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 01-Nov-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to Section 1 to add new name 'Boots Mouth Ulcer Gel'. $0$0$0$0Subsequent changes to Sections 4.4, 4.6 and 4.9 to remove the product name and replace with 'this medicine' or similar.$0 |
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Updated on 26/05/2006 and displayed until 24/11/2010
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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: 31/07/05 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.1 Anise oil is now Star anise oil.
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Updated on 26/05/2006 and displayed until 26/05/2006
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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| Date of revision of text on the SPC: 31/07/05 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2 Changed format of section as requested by MHRA
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Updated on 26/05/2006 and displayed until 26/05/2006
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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: 31/07/05 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.1 Anise oil is now Star anise oil.
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Updated on 11/11/2002 and displayed until 26/05/2006
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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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