Summary of Product Characteristics
last updated on the eMC:
10/05/2007
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 10/05/2007 and displayed until Current
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 01/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| pharmacotherapeutic group added
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Updated on 28/09/2006 and displayed until 10/05/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 27/09/2006 and displayed until 28/09/2006
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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 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: 03/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - Change to MA holder
Section 8 - Change to MA number in lin with above
Section 9 - Grant date in line with above
Section 10 - Change to text as per above
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Updated on 19/09/2003 and displayed until 27/09/2006
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 03/07/2001 and displayed until 19/09/2003
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Reasons for adding or updating:
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Updated on 09/04/2001 and displayed until 03/07/2001
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Reasons for adding or updating:
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