Summary of Product Characteristics
last updated on the eMC:
05/07/2011
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 05/07/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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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 4.9 - Overdose
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 21-Jun-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| This UK licence has been updated to remove the term ‘Enteric-coated’ from the product name and replace it with ‘gastro-resistant’ in accordance with the BP monograph.
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Updated on 19/04/2011 and displayed until 05/07/2011
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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: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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