Summary of Product Characteristics
last updated on the eMC:
29/01/2010
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 29/01/2010 and displayed until Current
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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 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-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The MAH has changed from Aventis (Roussel) to Winthrop Pharmaceuticals
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Updated on 09/09/2009 and displayed until 29/01/2010
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to dates in Section 9 and 10 due to renewal of licence
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Updated on 30/08/2005 and displayed until 09/09/2009
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Reasons for adding or updating:
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Change from BAN to rINN
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Change to section 10 (date of (partial) revision of the text
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Updated on 03/06/2004 and displayed until 30/08/2005
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Reasons for adding or updating:
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