Summary of Product Characteristics
last updated on the eMC:
03/02/2010
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 03/02/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic 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: 28-Jan-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 5.2 - Pharmacokinetic properties
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re-written to provide more detail
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Change to section 10 – Date of revision of the text
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Changed to 28 Jan 10
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Updated on 14/01/2010 and displayed until 03/02/2010
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 24-Dec-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 6.3 – Shelf Life
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Reduction in shelf life from 5 years to 3 years
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Change to section 10 – Date of revision of the text
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Changed to 24 Dec 09
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Updated on 05/01/2010 and displayed until 14/01/2010
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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: 23-Dec-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 5.1 - Addition of ATC code
Change to section 10 - Changed to 23 Dec 09
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Updated on 01/05/2009 and displayed until 05/01/2010
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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: 28-Apr-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 7 – Marketing Authorisation Holder
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Address change of MAH
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Change to section 10 – Date of revision of the text
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28 April 2009
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Updated on 28/02/2006 and displayed until 01/05/2009
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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Change to section 10 (date of (partial) revision of the text
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Updated on 16/02/2006 and displayed until 28/02/2006
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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 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 10 (date of (partial) revision of the text
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Updated on 20/09/2002 and displayed until 16/02/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 27/08/2002 and displayed until 20/09/2002
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 22/08/2002 and displayed until 27/08/2002
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 04/09/2001 and displayed until 22/08/2002
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Reasons for adding or updating:
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