Summary of Product Characteristics
last updated on the eMC:
14/04/2010
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 14/04/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 31-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to sections 7, 8 and 10 following approval of change of ownership.
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Updated on 12/03/2008 and displayed until 14/04/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 10/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change of MAH
Change of MA Number
Change of Date of Revision of Text
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Updated on 13/09/2006 and displayed until 12/03/2008
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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| Date of revision of text on the SPC: 07/2005 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.3 Contra-indications Add Gout as conra-indication at request of MHRA
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Updated on 22/08/2006 and displayed until 13/09/2006
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Pending awaiting re-submission
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Pending awaiting re-submission
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Pending awaiting re-submission
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Pending awaiting re-submission
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| Date of revision of text on the SPC: 07/2005 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.3 Add contra-indication of gout
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Updated on 18/09/2002 and displayed until 22/08/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 28/08/2002 and displayed until 18/09/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 07/08/2002 and displayed until 28/08/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 17/07/2002 and displayed until 07/08/2002
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Reasons for adding or updating:
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Change from datasheet to SPC
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Updated on 04/09/2001 and displayed until 17/07/2002
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Reasons for adding or updating:
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