Summary of Product Characteristics
last updated on the eMC:
01/06/2010
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 01/06/2010 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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 25-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SmPC: Section 4.4 (Special Warnings): W
ording update for phenytoin-related Stevens Johnson Syndrome (SJS) and association with HLA-B*1502.
ording update for phenytoin-related Stevens Johnson Syndrome (SJS) and association with HLA-B*1502.
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Updated on 01/12/2008 and displayed until 01/06/2010
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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 28/04/2008 and displayed until 01/12/2008
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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-Jan-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 6.3 Reduction in Shelf Life from 36 months to 30 months
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Updated on 06/03/2008 and displayed until 28/04/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 19/09/2007 and displayed until 06/03/2008
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Reasons for adding or updating:
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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: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10 - Change to date of revision and change to version code.
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Updated on 11/07/2006 and displayed until 19/09/2007
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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 2 - qualitative and quantitative composition
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Reason for Submission: Change to section 3 - pharmaceutical form, Change to section 2 - qualitative and quantitative composition
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Updated on 06/07/2006 and displayed until 11/07/2006
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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 3 - pharmaceutical form
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| Date of revision of text on the SPC: 07/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2. changed from 'Phenytoin sodium 250mg/ 5ml (50mg/ml) to 250 mg (50mg/ml).
Section 3. changed from 'Clear, colourless, sterile solution for injection to 'Clear, colourless, sterile solution'
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Updated on 17/05/2006 and displayed until 06/07/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 09/05/2006 and displayed until 17/05/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Pending awaiting re-submission
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Updated on 13/12/2005 and displayed until 09/05/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 06/12/2005 and displayed until 13/12/2005
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Reasons for adding or updating:
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Updated on 30/03/2005 and displayed until 06/12/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 23/03/2004 and displayed until 30/03/2005
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Reasons for adding or updating:
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