Summary of Product Characteristics
last updated on the eMC:
09/05/2012
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 09/05/2012 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-May-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SPC update to section 5.1. Pharmacodynamic Properties
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Updated on 22/02/2012 and displayed until 09/05/2012
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 01-Feb-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SPC change to section 5.2 Pharmacokinetic Properities of the SPC.
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Updated on 02/02/2012 and displayed until 22/02/2012
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 01-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 06/01/2012 and displayed until 02/02/2012
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Reasons for adding or updating:
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 01-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to section 4.7 of the SPC
Update to section 4.9 of the SPC
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Updated on 26/04/2011 and displayed until 06/01/2012
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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: 01-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to Section 6.5 involving addition of a new 30ml bottle presentation.
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Updated on 09/03/2011 and displayed until 26/04/2011
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 01-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.3 – Shelf-life
Changed from 36 months to 24 months.
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Updated on 27/01/2011 and displayed until 09/03/2011
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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: 01-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 6.5
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Updated on 09/09/2009 and displayed until 27/01/2011
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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: 01-Sep-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Renewal Approval received August 2009 so dates of renewal and date of last update have been updated.
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Updated on 23/01/2009 and displayed until 09/09/2009
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 01-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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update section 4.3 - Text amended to align with CDS
update section 4.5 - New interations warning text (previously none)
update section 4.8 - New adverse effects information added
update section 4.9 - New overdose information added
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Updated on 23/10/2007 and displayed until 23/01/2009
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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: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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7. Marketing Authorisation Holder
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Updated on 31/01/2005 and displayed until 23/10/2007
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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 5 - Pharmacological Properties
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Updated on 07/01/2003 and displayed until 31/01/2005
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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 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 17/07/2001 and displayed until 07/01/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 24/08/2000 and displayed until 17/07/2001
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Reasons for adding or updating:
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