Summary of Product Characteristics
last updated on the eMC:
07/04/2010
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 07/04/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 13-Jan-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.6 for pregnancy
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Updated on 29/03/2010 and displayed until 07/04/2010
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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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: 13-Jan-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The reasons for change are the following:
Section 4.1 – new indication
Section 4.2 – change to dosing regimen
Section 4.4 change to special warnings to include information on lung disease
Section 4.5 – updated information on pregnancy
Section 5.1 – inclusion of statement regarding weight control
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Updated on 02/03/2009 and displayed until 29/03/2010
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Reasons for adding or updating:
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Addition of Legal Category
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| Date of revision of text on the SPC: 01-Feb-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| This is not an addition of legal status this is a change from P to GSL
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Updated on 17/04/2008 and displayed until 02/03/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to MA as a result of integration.
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Updated on 18/01/2006 and displayed until 17/04/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 17/01/2006 and displayed until 18/01/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 30/11/2005 and displayed until 17/01/2006
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Updated on 09/09/2005 and displayed until 30/11/2005
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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 30/09/2004 and displayed until 09/09/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 19/08/2002 and displayed until 30/09/2004
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 15/08/2002 and displayed until 19/08/2002
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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 08/08/2001 and displayed until 15/08/2002
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 17/07/2001 and displayed until 08/08/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 30/04/2001 and displayed until 17/07/2001
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Updated on 19/12/2000 and displayed until 30/04/2001
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Updated on 06/09/1999 and displayed until 19/12/2000
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