Summary of Product Characteristics
last updated on the eMC:
25/07/2011
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 25/07/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 24-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Renewal of Marketing Authorisation
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Updated on 18/11/2010 and displayed until 25/07/2011
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 23-Feb-2009 |
| 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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Updated on 17/12/2008 and displayed until 18/11/2010
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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: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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