Summary of Product Characteristics
last updated on the eMC:
26/03/2012
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 26/03/2012 and displayed until Current
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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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Change to section 4.6 - Pregnancy and Lactation
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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: 14-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| A result of a Core Company Safety Information (CCSI) review, an update was made to section 4.2 of the SmPC to include reference to renal failure and use in children.
The heading of SPC section 4.6 was also updated in line with SPC guidelines
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Updated on 02/08/2011 and displayed until 26/03/2012
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.3 - Contraindications
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Change to section 5.1 - Pharmacodynamic Properties
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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: 22-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The sections have been updated to bring them in line with the brand leader Lipantil.
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Updated on 09/12/2010 and displayed until 02/08/2011
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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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