Summary of Product Characteristics
last updated on the eMC:
20/11/2009
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 20/11/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 10-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update of overdose section to include the symptoms of overdose, as well as advice concerning hypokalaemia.
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Updated on 03/04/2009 and displayed until 20/11/2009
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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: 01-Nov-2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Shelf life information updated to 3 years
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Updated on 11/02/2009 and displayed until 03/04/2009
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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| Date of revision of text on the SPC: 01-Nov-2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 8: Licence number updated
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Updated on 11/08/2008 and displayed until 11/02/2009
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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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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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