Summary of Product Characteristics
last updated on the eMC:
23/02/2009
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 23/02/2009 and displayed until Current
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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 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: 27-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 8: Change of PL numbers to: Priadel 04425/0325, Priadel 200mg 04425/0322
Section 9: Change of date to 27th January 2009
Section 10: Change of date to 27th January 2009
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Updated on 06/03/2008 and displayed until 23/02/2009
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Reasons for adding or updating:
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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: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Amendment to section 6.5 to reflect containers currently marketed.
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Updated on 04/09/2007 and displayed until 06/03/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7: Market Authorisation Holder
Change to sanofi-aventis from Sanofi-synthelabo
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Updated on 26/09/2006 and displayed until 04/09/2007
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 6.4 (Special precautions for storage): change to wording regarding storage conditions
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Updated on 04/08/2005 and displayed until 26/09/2006
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/11/2004 and displayed until 04/08/2005
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 10 (date of (partial) revision of the text
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Updated on 17/09/2004 and displayed until 24/11/2004
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 10 (date of (partial) revision of the text
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Updated on 03/10/2003 and displayed until 17/09/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 16/07/2002 and displayed until 03/10/2003
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 28/08/2001 and displayed until 16/07/2002
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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