Summary of Product Characteristics
last updated on the eMC:
01/06/2011
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 01/06/2011 and displayed until Current
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Reasons for adding or updating:
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Change due to harmonisation of SPC
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| Date of revision of text on the SPC: 28-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Renewal of MA
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Updated on 18/09/2008 and displayed until 01/06/2011
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Improved Electronic Presentation
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| Date of revision of text on the SPC: 20-Nov-2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 11/09/2007 and displayed until 18/09/2008
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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 4.8 - Undesirable Effects
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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: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Addition of rare cases of "veno-occlusive disease" to adverse effects.
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Updated on 29/09/2005 and displayed until 11/09/2007
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Reasons for adding or updating:
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 16/07/2001 and displayed until 29/09/2005
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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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Updated on 06/09/1999 and displayed until 16/07/2001
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Reasons for adding or updating:
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