Summary of Product Characteristics
last updated on the eMC:
12/10/2010
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 12/10/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 30-Sep-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To extend the indications to include ‘harm reduction’ following advice from the CHM, with updates made to sections 4.1 (Therapeutic indications), 4.2 (Posology and method of administration) and 4.6 (Pregnancy and lactation)
Section 4.1 now includes an indication for pregnant and lactating women, and people who wish to cut down with no immediate plans to quit
Section 4.2 now includes directions for use for a reduction in smoking for smokers who wish to cut down with no immediate plans to quit
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Updated on 28/08/2009 and displayed until 12/10/2010
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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: 10-Jul-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to section 4.8 to include anaphylactic reactions
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Updated on 21/09/2007 and displayed until 28/08/2009
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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 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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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: 06/2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - 'CQ' removed from Trade name
Section 4.1 - Addition of indication for temporary abstinence
Section 4.2 - Addition of directions for use for temporary abstinence
Section 10 - Date of revision of text updated to June 2007
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Updated on 05/01/2007 and displayed until 21/09/2007
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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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: 12/2006 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 Therapeutic Indications - addition of a new indication, gradual smoking cessation (i.e. cut down to quit)
Section 4.2 Posology and the method of administration - addition of the section on gradual smoking cessation
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Updated on 25/01/2006 and displayed until 05/01/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 23/01/2006 and displayed until 25/01/2006
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 10 (date of (partial) revision of the text
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Updated on 23/12/2003 and displayed until 23/01/2006
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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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