Summary of Product Characteristics
last updated on the eMC:
06/11/2009
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 06/11/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 01-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.5 - clozapine added
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Updated on 07/04/2009 and displayed until 06/11/2009
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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: 01-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 8: Change to Marketing Authorisation Number: PL04425/0286
Section 9: Date of Renewal of Authorisation: 6 Febraury 2009
Section 10: Date of Revision of text: February 2009
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Updated on 18/09/2007 and displayed until 07/04/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| 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.
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Updated on 19/09/2006 and displayed until 18/09/2007
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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: 03/2004 |
| 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): Change to MA Holder's address
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Updated on 04/04/2005 and displayed until 19/09/2006
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 04/08/2004 and displayed until 04/04/2005
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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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Updated on 26/09/2002 and displayed until 04/08/2004
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 23/08/2001 and displayed until 26/09/2002
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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