Summary of Product Characteristics
last updated on the eMC:
17/02/2009
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 17/02/2009 and displayed until Current
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 11-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 7 - New MAH address
Change to section 10 - Changed to 11 February 2009
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Updated on 14/01/2009 and displayed until 17/02/2009
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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: 07-Jan-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 - Date of the Renewal Authorisation
Change to section 10 - Changed to 07th January 2009
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Updated on 27/08/2004 and displayed until 14/01/2009
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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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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 10 (date of (partial) revision of the text
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Updated on 02/07/2002 and displayed until 27/08/2004
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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 29/08/2001 and displayed until 02/07/2002
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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 31/10/2000 and displayed until 24/08/2001
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Updated on 11/08/2000 and displayed until 31/10/2000
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