Summary of Product Characteristics
last updated on the eMC:
03/02/2012
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 03/02/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.6 - Pregnancy and Lactation
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 19-Dec-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update in line with MA holder company core information.
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Updated on 16/06/2011 and displayed until 03/02/2012
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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: 31-Mar-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of MA holder, Solvay to Abbott.
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Updated on 09/08/2010 and displayed until 16/06/2011
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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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