Summary of Product Characteristics
last updated on the eMC:
14/11/2008
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 14/11/2008 and displayed until Current
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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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| Date of revision of text on the SPC: 01-Oct-2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 9 (Renewal of the Authorisation) : the date has changed to "2 September 2007".
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Updated on 18/02/2008 and displayed until 14/11/2008
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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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| Date of revision of text on the SPC: 10/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.5 - Interaction with other medicinal products and other forms of interaction: Additional text in bold has been added, as follows: " ... blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote."
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Updated on 11/09/2007 and displayed until 18/02/2008
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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: 09/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5 - Nature and contents of container - Deletion of text 'This is supplied as an original pack (OP)'
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Updated on 03/08/2004 and displayed until 11/09/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 19/06/2003 and displayed until 03/08/2004
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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 4.3 - Contra-indications
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Change to section 10 (date of (partial) revision of the text
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Updated on 17/09/2002 and displayed until 19/06/2003
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 4.2 - Posology and Method of Administration
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Change to section 10 (date of (partial) revision of the text
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Updated on 11/02/2002 and displayed until 17/09/2002
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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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Updated on 01/02/2002 and displayed until 11/02/2002
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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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Updated on 19/07/2001 and displayed until 01/02/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 08/02/2001 and displayed until 19/07/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 08/02/2001
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Reasons for adding or updating:
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