Summary of Product Characteristics
last updated on the eMC:
15/11/2010
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 15/11/2010 and displayed until Current
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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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| Date of revision of text on the SPC: 01-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SmPC (Section 6.5 – Pack size amended to refer number of units instead of number of blisters)
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Updated on 20/02/2009 and displayed until 15/11/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Type II variation to update section 4.8
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Updated on 04/12/2008 and displayed until 20/02/2009
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- Minor change to section 4.5 to include an additional iso-enzyme.
- Update to section 4.8 to include additional side effects within the table and discuss impact on dementia.
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Updated on 29/11/2007 and displayed until 04/12/2008
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.8 – Changes to side effects section including addition of new side effects
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Updated on 14/06/2007 and displayed until 29/11/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 21/05/2007 and displayed until 14/06/2007
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.8 - Undesirable Effects
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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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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections changed: 4.2, 4.8, 5.1, 5.2
The SPC was updated in line with the text agreed during the EU Worksharing procedure for paediatric data for this product.
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Updated on 09/11/2005 and displayed until 21/05/2007
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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 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic 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 22/12/2004 and displayed until 09/11/2005
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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 5.1 - Pharmacodynamic Properties
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Change to section 7 - Marketing Authorisation Holder
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Updated on 02/12/2003 and displayed until 22/12/2004
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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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 4.8 - Undesirable Effects
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Change to section 6.1 - List of Excipients
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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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Updated on 30/09/2003 and displayed until 02/12/2003
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 25/09/2003 and displayed until 30/09/2003
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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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 4.8 - Undesirable Effects
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 01/10/2001 and displayed until 25/09/2003
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Reasons for adding or updating:
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