Summary of Product Characteristics
last updated on the eMC:
24/08/2010
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 24/08/2010 and displayed until Current
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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 4.8 - Undesirable Effects
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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: 28-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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The changes made have brought the SPC in line with the Company Core Data Sheet. Adaptations were made in the following SmPC sections:
· Section 4.4 'Special warnings and precautions for use':
inclusion of a statement on possible adherence of the ring to vaginal tissue
update of the section on cervical cancer
· Section 4.8 'Undesirable effects':
additional grouping of several preferred terms
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Updated on 23/01/2009 and displayed until 24/08/2010
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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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