Summary of Product Characteristics
last updated on the eMC:
25/04/2012
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 25/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 05-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update the container closure system by adding an additional package
presentation; HDPE bottle in an aluminium foil pouch in a carton with shelf-life of
24 months. Section 6.5 (Nature and content of container) and section 6.3 (shelf life)
of the SmPC has been updated. Leaflet and labelling have not been
assessed/ approved as part of this variation.
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Updated on 18/01/2012 and displayed until 25/04/2012
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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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: 05-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Type II variation resulting from CCSI update.
To update SmPC’s and PIL’s in line with Core Company Safety Information (CCSI) Version 2.
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Updated on 22/07/2011 and displayed until 18/01/2012
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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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