Summary of Product Characteristics
last updated on the eMC:
01/12/2011
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 01/12/2011 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 6.1 - List of Excipients
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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: 01-Apr-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Flavour changed from apricot to blackcurrant, subsequent changes to section 1, 6.1 and 6.5
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Updated on 11/05/2009 and displayed until 01/12/2011
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 01-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Marketing authorisation number has changed
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Updated on 08/08/2007 and displayed until 11/05/2009
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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: 03/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 marketing authorisation holder - changed to sanofi-aventis
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Updated on 20/11/2006 and displayed until 08/08/2007
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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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