Summary of Product Characteristics
last updated on the eMC:
26/10/2011
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 26/10/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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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: 01-Aug-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 6.1 (List of excipients) the following text has been added: "(trolamine lauril sulfate)", "Ammonium Sulphate" and "Purified Water"
In section 10 (Date of Revision of the Text) the date has changed to "August 2011"
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Updated on 14/09/2007 and displayed until 26/10/2011
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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 4.4 - Special warnings and precautions for Use
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Change to section 6.1 - List of Excipients
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 3 - Pharmaceutical Form - Addition of word 'Viscous'
Section 4.4 - Special warnings and precautions for use - Addition of text 'Keep out of the reach of children'
Section 6.1 - List of Excipients - Deletion of word 'Water'
Section 9 - Renewal of the Authorisation - Date changed to '29 January 2006'
Section 10 - Date of revision of the text - Date changed to 'July 2006'
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Updated on 07/09/2004 and displayed until 14/09/2007
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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 03/08/2004 and displayed until 07/09/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 17/09/2002 and displayed until 03/08/2004
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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 19/07/2001 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 31/01/2001 and displayed until 19/07/2001
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Updated on 06/09/1999 and displayed until 31/01/2001
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