Summary of Product Characteristics
last updated on the eMC:
10/12/2007
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 10/12/2007 and displayed until Current
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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: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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update section 4.8 of the SPC to reflect the MedDRA SOC format and frequencies assigned according to CIOMS, as per current guidance
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Updated on 03/04/2007 and displayed until 10/12/2007
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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: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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7. Marketing Authorisation Holder Glaxo Wellcome UK Ltd
trading as
Glaxo Laboratories and/or GlaxoSmithKline UK
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Updated on 22/02/2007 and displayed until 03/04/2007
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Reasons for adding or updating:
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Change to section 6. 6 - Instructions for use, handling and disposal
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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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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 14/02/2007 and displayed until 22/02/2007
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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 4.9 - Overdose
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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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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 22/09/2004 and displayed until 14/02/2007
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 10/03/2003 and displayed until 22/09/2004
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 11/08/2001 and displayed until 10/03/2003
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Reasons for adding or updating:
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Updated on 12/07/2000 and displayed until 11/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 12/07/2000
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Reasons for adding or updating:
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