Summary of Product Characteristics
last updated on the eMC:
29/03/2012
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 29/03/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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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: 12-Mar-2012 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to SPC sections 1 (Name of the Medicinal Product) and 10 (Revision date).
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Updated on 09/02/2012 and displayed until 29/03/2012
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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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: 01-Jan-2012 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 3 (Pharmaceutical Form) - include the EDQM short term '(Tablets)'
Section 10 - Date change
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Updated on 09/11/2010 and displayed until 09/02/2012
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Reasons for adding or updating:
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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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