Summary of Product Characteristics
last updated on the eMC:
07/08/2008
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 07/08/2008 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: POM |
| 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 22 May 2008.
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Updated on 18/02/2008 and displayed until 07/08/2008
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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: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Setion 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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 09/2007 |
| Legal Category: POM |
| 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 - Text deleted 'This is supplied as an original pack (OP)'
Section 10 - Date of revision of the text - Date changed to 'June 2005'
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Updated on 14/09/2006 and displayed until 11/09/2007
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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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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 10/2004 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 9 - Renewal of the Authorisation: The date has changed from "3 March 2000" to "2 March 2005"
Section 10 - Date of Revision of the Text: The date has changed from "October 2002" to "October 2004"
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Updated on 03/08/2004 and displayed until 14/09/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 09/01/2003 and displayed until 03/08/2004
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Updated on 17/09/2002 and displayed until 09/01/2003
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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 10/08/2001 and displayed until 17/09/2002
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Transferred from eMC version 1
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Updated on 27/06/2000 and displayed until 10/08/2001
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Reasons for adding or updating:
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