Summary of Product Characteristics
last updated on the eMC:
04/05/2011
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 04/05/2011 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 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 01-Nov-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Codeine breastfeeding warnings.
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Updated on 24/11/2010 and displayed until 04/05/2011
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 01-Jun-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to the printing ink in the list of excipients in Section 6.1. |
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Updated on 28/09/2010 and displayed until 24/11/2010
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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 4.1 - Therapeutic indications
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| Date of revision of text on the SPC: 01-Sep-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to Section 4.1 and 4.4 with regarding to codeine warnings |
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Updated on 13/01/2009 and displayed until 28/09/2010
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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| Date of revision of text on the SPC: |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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