Summary of Product Characteristics
last updated on the eMC:
04/11/2009
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 04/11/2009 and displayed until Current
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Reasons for adding or updating:
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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: 01-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 6.5: Additional pack size added for solution and standard statement that not all pack sizes may be marketed.
Section 10: Updated to reflect inclusion of above in annex issued by EC.
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Updated on 05/03/2009 and displayed until 04/11/2009
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Reasons for adding or updating:
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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: 02-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.4, addition of class wording regarding the monitoing of suicidal ideation and behaviours.
Section 10, updated to reflect approval of variation to include new wording in section 4.4.
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Updated on 12/09/2008 and displayed until 05/03/2009
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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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