Summary of Product Characteristics
last updated on the eMC:
04/03/2009
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 04/03/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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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-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.1 ( List of excipients) -
‘calcium disodisodium edetate’ was changed to ‘sodium calcium edetate’
‘tromethamine’ was changed to ‘trometamol’
Section 10 (Revision Date) - this has been amended to 22 January 2009.
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Updated on 13/05/2008 and displayed until 04/03/2009
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Reasons for adding or updating:
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New individual SPC (was previously included in combined SPC)
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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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