Summary of Product Characteristics
last updated on the eMC:
27/01/2010
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 27/01/2010 and displayed until Current
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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 6.2 - Incompatibilities
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| Date of revision of text on the SPC: 24-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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To update Section 4.5 of the SPC to include interaction with terbinafine.
To update Section 6.2 of the SPC to align with the Company Core Data Sheet.
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Updated on 02/05/2008 and displayed until 27/01/2010
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 25-Mar-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SECTIONS 4.4 and 4.8:
Updated to include suicidal thoughts and behaviour
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Updated on 28/09/2006 and displayed until 02/05/2008
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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 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SECTION 4.2:
- Paragraph on treatment discontinuation added
SECTION 4.4:
- Paragraph on "use in children and adolescents (0-17 years of age)" added
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Updated on 27/09/2004 and displayed until 28/09/2006
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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 4.4 - 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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Updated on 19/09/2003 and displayed until 27/09/2004
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 20/08/2001 and displayed until 19/09/2003
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 12/01/2001 and displayed until 20/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 12/01/2001
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Reasons for adding or updating:
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