Summary of Product Characteristics
last updated on the eMC:
06/01/2012
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 06/01/2012 and displayed until Current
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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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| Date of revision of text on the SPC: 01-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4, paragraph on 'infections' - text updated in line with originator
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Updated on 19/12/2011 and displayed until 06/01/2012
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Reasons for adding or updating:
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Change to separate SPCs covering individual presentations
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| Date of revision of text on the SPC: 01-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Previously one SPC for all strengths, now single SPC for each strength
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Updated on 14/07/2011 and displayed until 19/12/2011
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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: 23-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.3: Shelf-life increased to 30 months
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Updated on 21/01/2011 and displayed until 14/07/2011
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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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