Summary of Product Characteristics
last updated on the eMC:
02/02/2011
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 02/02/2011 and displayed until Current
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Reasons for adding or updating:
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Improved Electronic Presentation
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| Date of revision of text on the SPC: 30-Nov-2010 |
| 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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Updated on 18/01/2011 and displayed until 02/02/2011
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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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: 30-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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The key changes are:
- To add a new indication, "Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception", to section 4.1 (Indications) of the SPC, with consequential changes to sections 4.8 (Undesirable effects) and 5.1 (Pharmacodynamic properties).
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Updated on 15/05/2009 and displayed until 18/01/2011
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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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