Summary of Product Characteristics
last updated on the eMC:
07/09/2010
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 07/09/2010 and displayed until Current
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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: 14-Feb-2007 |
| 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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Updated on 13/06/2007 and displayed until 07/09/2010
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Reasons for adding or updating:
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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: 02/2007 |
| Legal Category: P |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 9 now states 30/11/2005 instead of 18th April 2005
Section 10 now states 14/02/2007 instead of August 2006
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Updated on 19/02/2007 and displayed until 13/06/2007
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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: 08/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The Hard fat excipient has changed from Loders to Biscutine 621
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Updated on 09/05/2005 and displayed until 19/02/2007
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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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