Summary of Product Characteristics
last updated on the eMC:
06/06/2011
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 06/06/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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| Date of revision of text on the SPC: 10-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.7 wording has been updated in line with standard terminology and now reads:
No observed effects.
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Updated on 21/04/2009 and displayed until 06/06/2011
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 9
Date of First Authorisation/Renewal of the Authorisation
04 November 1981/ 16 March 2009-04-08
Section 10
Date of Revision of the Text
March 2009
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Updated on 20/03/2006 and displayed until 21/04/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 30/09/2002 and displayed until 20/03/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 21/08/2001 and displayed until 30/09/2002
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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