Summary of Product Characteristics
last updated on the eMC:
25/01/2012
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 25/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 01-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 - reference to the excipient 'Sunset yellow (E110)' removed
Section 3 - description of capsule shell amended
Section 4.4 - reference to the excipient 'Sunset yellow (E110)' removed
Section 6.1 - reference to the excipient 'Sunset yellow (E110)' removed and details of the imprinting ink added
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Updated on 05/07/2010 and displayed until 25/01/2012
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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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