Summary of Product Characteristics
last updated on the eMC:
15/04/2011
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 15/04/2011 and displayed until Current
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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: 07-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The Date of Revision of Text
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Updated on 26/04/2010 and displayed until 15/04/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 16-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 7 change to marketing authorisation holder
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Updated on 16/10/2009 and displayed until 26/04/2010
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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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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: 13-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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section 4.4 - Inclusion of Stevens-Johnson syndrome and toxic epidermal necrolysis
section 4.8 -Inclusion of Stevens-Johnson syndrome and toxic epidermal necrolysis under Skin and subcutaneous tissue disorders section. Paragraph included on HLA-B*5801 allele
section 10 - Date changed to 13 October 2009
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Updated on 11/06/2009 and displayed until 16/10/2009
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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: 04-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Updated this section of the SmPC with lactose excipient warning. consequential update to section 2 of the PIL.
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Updated on 26/09/2006 and displayed until 11/06/2009
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 09/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 22/05/2006 and displayed until 26/09/2006
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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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| Date of revision of text on the SPC: 22/05/06 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 08/02/2005 and displayed until 22/05/2006
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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 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 22/10/2004 and displayed until 08/02/2005
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 26/04/2004 and displayed until 22/10/2004
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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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Change to section 7 - Marketing Authorisation Holder
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Updated on 09/07/2002 and displayed until 26/04/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 01/07/2002 and displayed until 09/07/2002
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 25/06/2002 and displayed until 01/07/2002
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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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Updated on 16/08/2001 and displayed until 25/06/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 22/05/2002 and displayed until 16/08/2001
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Reasons for adding or updating:
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Updated on 09/04/2001 and displayed until 22/05/2002
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