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 reduce before quitting
Section 4.2 now includes directions for use for a reduction in smoking
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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 12/08/2009 and displayed until 28/08/2009
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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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