Summary of Product Characteristics
last updated on the eMC:
25/01/2012
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 25/01/2012 and displayed until Current
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Reasons for adding or updating:
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Improved Electronic Presentation
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| Date of revision of text on the SPC: 01-Nov-2011 |
| 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 13/12/2011 and displayed until 25/01/2012
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.1 - Therapeutic indications
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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 4.7 - Effects on Ability to Drive and Use Machines
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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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Change to section 5 - Pharmacological Properties
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6.1 - List of Excipients
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Change to section 6.2 - Incompatibilities
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Change to section 6. 3 - Shelf Life
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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 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-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Updated to
all section of the SPC except for section 7 and 8
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Updated on 06/04/2011 and displayed until 13/12/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SmPC (SECTION 4.8 has been updated)
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Updated on 28/02/2008 and displayed until 06/04/2011
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 23/02/2005 and displayed until 28/02/2008
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 27/01/2004 and displayed until 23/02/2005
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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Updated on 11/07/2001 and displayed until 27/01/2004
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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 4.5 - Interactions with other Medicaments and other forms of Interaction
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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 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 10 (date of (partial) revision of the text
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Updated on 05/04/2000 and displayed until 11/07/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 05/04/2000
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Reasons for adding or updating:
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