Summary of Product Characteristics
last updated on the eMC:
07/04/2010
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 07/04/2010 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-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Please note that we need to make a minor change to the EMC SPC.
The approval date should be February 2010.
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Updated on 03/12/2009 and displayed until 07/04/2010
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.6 – Use during pregnancy and lactation to add “Naloxone rapidly crosses the placental barrier so that some therapeutic effect may be anticipated in the neonate”
In section 4.8 – Undesirable Effects to add "violent behaviour as a symptom of abrupt reversal of narcotic depression and the rare occurrence of seizure from the administration of Naloxone"
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Updated on 04/09/2007 and displayed until 03/12/2009
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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: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Shelf-life increased from 2-3 years.
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Updated on 24/11/2005 and displayed until 04/09/2007
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 3 - pharmaceutical form
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 03/10/2003 and displayed until 24/11/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 28/06/2001 and displayed until 03/10/2003
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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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