Summary of Product Characteristics
last updated on the eMC:
19/04/2012
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 19/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 04-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| update on pregnancy
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Updated on 26/07/2011 and displayed until 19/04/2012
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 30-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Change of the year of Annual strain
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Updated on 23/03/2011 and displayed until 26/07/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.2 - Posology and method of administration
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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 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 24-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Update of the SmPC to be in line with the new guidelines
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Updated on 27/08/2010 and displayed until 23/03/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 18-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Anuual Strain change
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Updated on 27/05/2010 and displayed until 27/08/2010
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 19-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Marketing Authorisation Numbers Revised
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Updated on 21/05/2009 and displayed until 27/05/2010
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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