Summary of Product Characteristics
last updated on the eMC:
01/12/2008
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 01/12/2008 and displayed until Current
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Reasons for adding or updating:
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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: 18-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Addition of class warning for anti-epileptics regarding suicidal ideation and behaviour
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Updated on 25/03/2008 and displayed until 01/12/2008
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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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: 01/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.1 Spelling of excipient updated from BANs to INNs spelling sodium laurilsulfate
10 Date of revision updated
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Updated on 28/08/2007 and displayed until 25/03/2008
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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 6.1 - List of Excipients
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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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| Date of revision of text on the SPC: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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1. updated to include strength and specify pharmaceutical form
2. text reformatted and required statements added.
6.1. one excipient updated to include hydrate form and text formatted into list. Sodium lauryl sulphate spelling corrected as per Ph Eur monograph nomenclature.
6.3 Packaging description removed
6.4 Storage advice amended in line with CPMP guidance.
6.5. updated to include required statement
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Updated on 02/04/2007 and displayed until 28/08/2007
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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 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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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: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 Updated to include strength and specify pharmaceutical form
Section 2 Text reformatted and required statement added
Section 6.1 One excipient updated to include hydrate form and text formatted into list
Section 6.5 Updated to include required statement
Section 10 Updated date of revision of the text
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Updated on 12/03/2007 and displayed until 02/04/2007
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 6.1 List of excipients - the composition of the printing ink has been changed.
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Updated on 10/08/2005 and displayed until 12/03/2007
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Reasons for adding or updating:
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Change from BAN to rINN
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 03/06/2005 and displayed until 10/08/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 11/04/2005 and displayed until 03/06/2005
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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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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Updated on 06/04/2004 and displayed until 11/04/2005
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Reasons for adding or updating:
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Company name change or merger
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Updated on 30/09/2003 and displayed until 06/04/2004
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Reasons for adding or updating:
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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 10 (date of (partial) revision of the text
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SPC Company name change or merger
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Updated on 19/09/2002 and displayed until 30/09/2003
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Reasons for adding or updating:
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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 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 24/08/2001 and displayed until 19/09/2002
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Reasons for adding or updating:
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