Summary of Product Characteristics
last updated on the eMC:
05/03/2010
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 05/03/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.9 - Overdose
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Change to section 10 date of revision of the text
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Change to section 1 -Name of the Medicinal product
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 01-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - Name changed 2% added
Section 4.4 - Whole section updated
Section 4.6 - Whole section updated
Section 4.9 - whole section updated
Section 10 - Date of approval added
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Updated on 04/06/2008 and displayed until 05/03/2010
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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: 21-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 9 - 21 May 2008
Section 10 - 21 May 2008
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Updated on 19/05/2004 and displayed until 04/06/2008
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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 17/05/2004 and displayed until 19/05/2004
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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 10/03/2003 and displayed until 17/05/2004
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 12/11/2002 and displayed until 10/03/2003
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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 26/09/2002 and displayed until 12/11/2002
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 29/07/2002 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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Updated on 05/08/2001 and displayed until 29/07/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 14/03/2000 and displayed until 05/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 14/03/2000
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