Summary of Product Characteristics
last updated on the eMC:
14/09/2009
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 14/09/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 29-Feb-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Added 20 and 60 sachet packs
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Updated on 22/01/2008 and displayed until 14/09/2009
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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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: 12/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to add once daily dosage for acute treatment of ulcerative colitis.
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Updated on 09/08/2007 and displayed until 22/01/2008
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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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: 03/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| "In sachets" has been removed from the name of the product, peripheral neuropathy and oligospermia has been added to section 4.8.
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Updated on 13/09/2006 and displayed until 09/08/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 07/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| cholestatic hepatitis has been added to section 4.8
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Updated on 29/09/2005 and displayed until 13/09/2006
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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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