Summary of Product Characteristics
last updated on the eMC:
13/11/2009
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 13/11/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 16-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| 6.3 Shelf-life has been changed from 24 months to 36 months.
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Updated on 04/07/2008 and displayed until 13/11/2009
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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: 16-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Black triangle added.
In section 4.8 (undesirable effects), disorders including aggression in children.......has been added.
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Updated on 17/07/2007 and displayed until 04/07/2008
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Reasons for adding or updating:
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Addition of joint SPC covering all presentations
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Updated on 26/01/2006 and displayed until 17/07/2007
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Reasons for adding or updating:
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