Summary of Product Characteristics
last updated on the eMC:
05/12/2011
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 05/12/2011 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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 15-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| indication for adjuvant treatment for breast cancer now includes 'operable node-negative breast cancer'. changes in section 4.8 undesirable effects are as a consequence of this addition.
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Updated on 15/03/2011 and displayed until 05/12/2011
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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):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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