Summary of Product Characteristics
last updated on the eMC:
25/03/2011
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 25/03/2011 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 10 date of revision of the text
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| Date of revision of text on the SPC: 20-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- Changes in Section 2:
'Indoramin hydrochloride 20 mg' has been replaced with 'Each film-coated tablet contains indoramin hydrochloride equivalent to 20 mg of indoramin base'.
-Changes in Section 10:
The last revision date has been updated to 20.01.2011
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Updated on 23/09/2009 and displayed until 25/03/2011
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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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