Summary of Product Characteristics
last updated on the eMC:
15/02/2011
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 15/02/2011 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: 26-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 6.3: Shelf life extended to 48 months for unopened ampoules.
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Updated on 28/07/2009 and displayed until 15/02/2011
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 27-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 6.4, the storage condition has changed from stroe at 4-8°C to "2-8°C."
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Updated on 04/07/2008 and displayed until 28/07/2009
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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):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 4.8 (undesirable effects), disorders including aggression in children......has been added.
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Updated on 19/09/2002 and displayed until 04/07/2008
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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 08/08/2001 and displayed until 19/09/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 18/01/2001 and displayed until 08/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 18/01/2001
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Reasons for adding or updating:
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