Summary of Product Characteristics
last updated on the eMC:
04/03/2009
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 04/03/2009 and displayed until Current
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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: 23-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 9 - Changed to 23 February 2009
Change to section 10 - Changed to 23 February 2009
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Updated on 07/05/2008 and displayed until 04/03/2009
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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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-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change
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eMC - Summary of Change Details Per Section
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Change to section 6.3 – Shelf Life
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Changed from 3 to 2 years
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Change to section 6.4 – Special Precautions for Storage
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Changed from 25C to 30C
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Change to section 10 – Date of revision of the text
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Changed to ‘April 2008’
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Updated on 01/03/2006 and displayed until 07/05/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Change to section 10 (date of (partial) revision of the text
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Updated on 30/09/2004 and displayed until 01/03/2006
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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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Change from the BAN of the active substance to the rINN
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Updated on 19/08/2004 and displayed until 30/09/2004
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 10 (date of (partial) revision of the text
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Updated on 16/01/2002 and displayed until 19/08/2004
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 09/01/2002 and displayed until 16/01/2002
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 29/08/2001 and displayed until 09/01/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 24/08/2001 and displayed until 29/08/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 13/02/2001 and displayed until 24/08/2001
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Reasons for adding or updating:
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Updated on 16/10/2000 and displayed until 13/02/2001
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Reasons for adding or updating:
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Updated on 03/08/2000 and displayed until 16/10/2000
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 03/08/2000
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Reasons for adding or updating:
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