Summary of Product Characteristics
last updated on the eMC:
20/02/2012
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 20/02/2012 and displayed until Current
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Reasons for adding or updating:
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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: 27-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1st June 2011
10 DATE OF REVISION OF THE TEXT
27th July 2011
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Updated on 10/02/2012 and displayed until 20/02/2012
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 11-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to MAH
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Updated on 19/03/2009 and displayed until 10/02/2012
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 01-Nov-2003 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Name of Marketing Authorisation Holder updated to reflect company name change
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Updated on 28/02/2007 and displayed until 19/03/2009
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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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| Date of revision of text on the SPC: 03/2000 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Correction of typing error in section 4.4 Special Warnings and Precautions for Use.
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Updated on 23/02/2007 and displayed until 28/02/2007
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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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| Date of revision of text on the SPC: 03/2000 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Correction of typing error in Section 4.4.
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Updated on 15/10/2001 and displayed until 23/02/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 06/07/2001 and displayed until 15/10/2001
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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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Updated on 06/09/1999 and displayed until 06/07/2001
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Reasons for adding or updating:
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