Summary of Product Characteristics
last updated on the eMC:
11/09/2008
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 11/09/2008 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-2006 |
| 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 "31 July 2008"
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Updated on 16/03/2007 and displayed until 11/09/2008
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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 6.1 - List of Excipients
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| Date of revision of text on the SPC: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Special warnings and special precautions for use: Addition of new text, as follows: "The excipients, chlorocresol and cetostearyl alcohol may on rare occasions give rise to allergice or local skin reactions (eg. contact dermatitis) in sensitive people."
Section 6.1 - List of excipients: Change of text from "Sodium Lauryl Sulphate" to "Sodium laurilsulfate."
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Updated on 17/08/2005 and displayed until 16/03/2007
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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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Updated on 03/08/2004 and displayed until 17/08/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 24/09/2003 and displayed until 03/08/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 02/07/2003 and displayed until 24/09/2003
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 3 - Shelf Life
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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 02/07/2003
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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 18/07/2001 and displayed until 17/09/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 18/07/2001
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