Summary of Product Characteristics
last updated on the eMC:
19/08/2011
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 19/08/2011 and displayed until Current
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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 revision of the text
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| Date of revision of text on the SPC: 15-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.5 Addition of new pack size
10.0 Date of revision updated
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Updated on 25/01/2011 and displayed until 19/08/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 19-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 -
GlaxoSmithKline UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
Trading as Stiefel
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
Section 8 - PL 19494/0075
Section 10 - 19 January 2011
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Updated on 07/09/2009 and displayed until 25/01/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 12-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7.0 Change of address of MAH
Section 10.0 Address updated June 2009
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Updated on 03/12/2008 and displayed until 07/09/2009
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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 9 - Date of first Authorisation/renewal of the Authorisation
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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-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 1, the name has been amended to incorporate the strengths of the actives.
In section 2, text amended to " For a fell list of excipients, see section 6.1".
In section 9, the date of renewal has been added.
In section 10, the latest date of approval has been added.
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Updated on 09/07/2007 and displayed until 03/12/2008
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 27/09/2005 and displayed until 09/07/2007
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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 21/11/2003 and displayed until 27/09/2005
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Reasons for adding or updating:
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