Summary of Product Characteristics
last updated on the eMC:
13/02/2012
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 13/02/2012 and displayed until Current
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Reasons for adding or updating:
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Change of Marketing Authorisation Holder
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| Date of revision of text on the SPC: 07-Jul-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change in the MAH Holder
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Updated on 18/08/2010 and displayed until 13/02/2012
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 10-Aug-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Removal of 40ml pack size.
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Updated on 25/03/2010 and displayed until 18/08/2010
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 10-Mar-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of new 500ml pack
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Updated on 23/08/2007 and displayed until 25/03/2010
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 03/2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 5.1 Addition of ATC code
Section 10 Update to date of revision of text
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Updated on 28/09/2006 and displayed until 23/08/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 05/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 7. Marketing Authorisation Holder to Genus Pharmaceuticals
Change to sectio 6.3. from 2 years to 3 years
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Updated on 24/09/2004 and displayed until 28/09/2006
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 13/11/2003 and displayed until 24/09/2004
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Reasons for adding or updating:
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