Updated on 19/12/2008 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
-
Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 10-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.4 – Special Warnings and Precautions for Use
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Update to implement warnings on suicidal thoughts and behaviour associated with antiepileptic medicines
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Change to section 10 – Date of revision of the text
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10 Dec 2008
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Updated on 01/09/2008 and displayed until 19/12/2008
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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: 14-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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6.1
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List of excipients
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Change the excipient name of polyethylene glycol to Macrogol 400.
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10.
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DATE OF REVISION OF THE TEXT
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14 August 2008
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Updated on 10/07/2008 and displayed until 01/09/2008
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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: 18-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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7.
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MARKETING AUTHORISATION HOLDER
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Change of address
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10.
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DATE OF REVISION OF THE TEXT
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June 2008
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Updated on 14/02/2008 and displayed until 10/07/2008
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Reasons for adding or updating:
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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 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.5 –Interaction with other medicinal products and other forms of interaction
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Addition of – Lithium, glyburide, valproic acid, dilitiazem, venlafaxine
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Change to section 5.2 - Pharmacokinetic properties
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risperidone.
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Updated on 15/11/2006 and displayed until 14/02/2008
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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 4.8 - Undesirable Effects
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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: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 4.7 - Updated - visual disturbances/blurred vision
Section 4.8 - Major update - post marketing data
Section 10 - Updated to 12.11.2006
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Updated on 13/07/2006 and displayed until 15/11/2006
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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 6.1 - List of Excipients
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
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Change to section 4.4 -
Special Warnings and Precautions for Use - Providing more information on withdrawing treatment of Topamax to reduce the potential for drug withdrawal convulsions and
Change to section 6.1 -
List of Excipients - Hypromellose (excipient name change)
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Updated on 20/04/2006 and displayed until 13/07/2006
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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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Change to section 10 (date of (partial) revision of the text
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Updated on 14/11/2005 and displayed until 20/04/2006
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Reasons for adding or updating:
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Addition of Black Triangle
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Updated on 03/08/2005 and displayed until 14/11/2005
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Reasons for adding or updating:
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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 4.4 - 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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Updated on 03/09/2004 and displayed until 03/08/2005
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Reasons for adding or updating:
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-
Change to section 10 (date of (partial) revision of the text
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Updated on 24/08/2004 and displayed until 03/09/2004
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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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 10 (date of (partial) revision of the text
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Updated on 30/07/2004 and displayed until 24/08/2004
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Reasons for adding or updating:
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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 10 (date of (partial) revision of the text
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Updated on 24/02/2004 and displayed until 30/07/2004
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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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Updated on 22/01/2004 and displayed until 24/02/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 10/12/2003 and displayed until 22/01/2004
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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 10 (date of (partial) revision of the text
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Updated on 24/09/2003 and displayed until 10/12/2003
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Reasons for adding or updating:
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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 10 (date of (partial) revision of the text
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Updated on 14/05/2003 and displayed until 24/09/2003
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Reasons for adding or updating:
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Change to section 1 - trade name
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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 4.2 - Posology and Method of Administration
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Change to section 4.8 - Undesirable Effects
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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. 4 - Special Precautions for Storage
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Change to section 10 (date of (partial) revision of the text
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Updated on 19/06/2002 and displayed until 14/05/2003
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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 4.8 - Undesirable Effects
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Updated on 18/06/2002 and displayed until 19/06/2002
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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 4.8 - Undesirable Effects
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Updated on 10/10/2001 and displayed until 18/06/2002
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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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Updated on 28/08/2001 and displayed until 10/10/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 23/08/2001 and displayed until 28/08/2001
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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