Summary of Product Characteristics
last updated on the eMC:
12/10/2011
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 12/10/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products 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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| Date of revision of text on the SPC: 06-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.2, starting treatment, missed tablets and vomiting and diarrhoea has been updated.
In section 4.3, contraindicatioin have been removed, now only two contraindications
Section 4.4 , information moved to section 4,2 and breast cancer infomration has been moved from section 4.8, Warnings and precatuions have been updated.
Section 4.5- new interaction sadded.
Section 4.6, general update.
Sectiomn 4.8 only change breast cancer information moved to section 4.4.
Section 4.9, general update.
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Updated on 19/02/2009 and displayed until 12/10/2011
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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: 11-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 7 - New MAH address
Change to section 10 - Changed to 11 February 2009
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Updated on 09/12/2008 and displayed until 19/02/2009
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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: 04-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 9 – Date of Renewal of Authorisation
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Addition of:
Renewal of Authorisation: 4 December 2008
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Change to section 10 – Date of revision of the text
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Changed to 4th December 2008
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Updated on 22/08/2001 and displayed until 09/12/2008
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 16/10/2000 and displayed until 22/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 16/10/2000
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Reasons for adding or updating:
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