Summary of Product Characteristics
last updated on the eMC:
07/01/2011
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 07/01/2011 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 6.1 - List of Excipients
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Change to section 6.2 - Incompatibilities
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 19-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 - reworded to be more explicit : "each tablet contains.."
Section 3 - information about score line expanded
Section 6.1 - in 1.25 and 10mg Methylhydroxypropylcellulose replaced with hypromellose
Section 6.2 - reworded to not applicable
Section 6.3 - shelf life for 10mg tablets changed from 4 to 5 years
Section 6.4 - reworded to state no specific conditions required
Section 6.5 - reworded to specify available packs
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Updated on 26/11/2009 and displayed until 07/01/2011
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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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