Summary of Product Characteristics
last updated on the eMC:
08/02/2008
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 08/02/2008 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: 02/2006 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 6.3 shelf life. Change shelf life from 18 to 36 months
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Updated on 22/12/2006 and displayed until 08/02/2008
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 07/2005 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To revert section 4.2 of the SPC (Posology and method of administration) back to the format prior to the approval of variation
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Updated on 02/07/2004 and displayed until 22/12/2006
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Updated on 20/06/2003 and displayed until 02/07/2004
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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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