Summary of Product Characteristics
last updated on the eMC:
20/07/2011
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 20/07/2011 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: 01-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 6.5 Nature and contents of container, changed to read:6.5 Nature and contents of container
Blisters of standard 200 μm and 250 μm Ineos AquaBa 130 and 20μm aluminium foil in cartons with 7 or 10 or 14 capsules per blister
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Updated on 29/09/2009 and displayed until 20/07/2011
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Reasons for adding or updating:
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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: 01-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The following information has been added or changed:
4.8
Undesirable Effects
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2Not Known (cannot be estimated from the available data)
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- hallucinations
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Psychiatric
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10. DATE OF REVISION OF THE TEXT
August 2008
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Updated on 18/09/2007 and displayed until 29/09/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 18/08/2006 and displayed until 18/09/2007
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Reasons for adding or updating:
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