Summary of Product Characteristics
last updated on the eMC:
19/04/2012
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 19/04/2012 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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 28-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 6.3 (Shelf life) the closed bottle shelf life has been increased from 18 months to 24 months.
In section10 (Date of revision of the text) the date has been updated to 28-Mar-2012.
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Updated on 13/01/2012 and displayed until 19/04/2012
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 16-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 6.5 (Nature and contents of container), The dosing device has been updated to read LDPE body, purple polystyrene plunger with a capacity of 10ml. The following text has also been added: Bottle adaptor: low density polyethylene
In section 10 (Date of revision of the text), the date has been updated to 16th Dec 2011
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Updated on 06/12/2010 and displayed until 13/01/2012
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Reasons for adding or updating:
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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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