Summary of Product Characteristics
last updated on the eMC:
17/10/2011
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 17/10/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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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 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 03-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to sections 2, 4.2 – 4.4, 4.6, 4.8, 5.1, 6.4, 6.5 & 6.6 to bring SPC in line with QRD SPC template
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Updated on 01/04/2010 and displayed until 17/10/2011
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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: 01-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Amendment to sections 7 and 10 following change of ownership approval
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Updated on 15/05/2009 and displayed until 01/04/2010
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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| Date of revision of text on the SPC: 01-Jul-2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 3. PHARMACEUTICAL FORM
amended to read : engraved with V
Bet
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Updated on 07/03/2007 and displayed until 15/05/2009
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 05/03/2007 and displayed until 07/03/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 02/03/2007 and displayed until 05/03/2007
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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| Date of revision of text on the SPC: 07/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 3 - The version on the emc has not yet been implemented so it has been replaced by the previous version
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Updated on 08/12/2006 and displayed until 02/03/2007
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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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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White, round, flat, with a score mark on one side and engraved with V
on the other side. Bet
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Updated on 01/08/2005 and displayed until 08/12/2006
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Reasons for adding or updating:
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Change to section 1 - trade name
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Updated on 20/07/2004 and displayed until 01/08/2005
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 20/07/2004 and displayed until 20/07/2004
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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 07/08/2001 and displayed until 20/07/2004
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Reasons for adding or updating:
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