Summary of Product Characteristics
last updated on the eMC:
22/05/2012
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 22/05/2012 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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 08-May-2012 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update sections 4.3 (Contraindications) and 4.4 (Special warnings and precautions for use) as requested and recommended by MHRA in a previous submission (Article 61 submission 0028).
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Updated on 17/01/2011 and displayed until 22/05/2012
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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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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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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.1 - Therapeutic indications
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| Date of revision of text on the SPC: 23-Dec-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 2, 4.1, 4.2, 4.4, 4.6, 4.9 and 5.1 have been updated in line with the CCSI.
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Updated on 26/05/2010 and displayed until 17/01/2011
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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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| Date of revision of text on the SPC: 04-May-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To change the name of the product for Boots Own Label Supplier from Boots Lip and Cold Sore Cream to Lip and Cold Sore Relief Cream
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Updated on 19/09/2008 and displayed until 26/05/2010
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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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