Summary of Product Characteristics
last updated on the eMC:
21/09/2011
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 21/09/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Introduction of new pack/pack size
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| Date of revision of text on the SPC: 01-Nov-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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To introduce additional pack sizes of 20g and 35g
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Updated on 28/10/2009 and displayed until 21/09/2011
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Reasons for adding or updating:
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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-Jun-2006 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change in manufacturing process
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Updated on 12/09/2006 and displayed until 28/10/2009
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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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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 09/2005 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.5 b) 40g pack has been added
Section 10 changed to September 2005
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Updated on 09/05/2006 and displayed until 12/09/2006
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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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Updated on 16/02/2005 and displayed until 09/05/2006
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Updated on 07/08/2001 and displayed until 16/02/2005
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 15/03/2001 and displayed until 07/08/2001
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Reasons for adding or updating:
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