Summary of Product Characteristics
last updated on the eMC:
12/04/2011
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 12/04/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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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: 04-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To remove the printed tablet markings from the finished product, in order to reduce the risk of potential supply problems. Consequentially, the finished
product specification, manufacturing process, section 3 and 6.1 of the SPC, label and leaflet have been updated.
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Updated on 03/02/2011 and displayed until 12/04/2011
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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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