Summary of Product Characteristics
last updated on the eMC:
27/01/2011
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 27/01/2011 and displayed until Current
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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: 22-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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7.
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GlaxoSmithKline UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
Trading as Stiefel
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
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8.
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PL 19494/0074
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10.
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22 January 2011
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Updated on 21/08/2009 and displayed until 27/01/2011
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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: 17-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7: Update to the address of the MAH
Section 10: Date updated
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Updated on 26/11/2008 and displayed until 21/08/2009
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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 4.1 - Therapeutic indications
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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: 01-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Warticon Solution was previously marketed in two formats: Warticon for male patients and Warticon FEM for female patients. The formulations were identical. The Warticon FEM pack has been discontinued and Warticon will be used for both indications going forward. The SmPC has been amended to delete references to Warticon FEM and to include both male and female indications for Warticon.
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Updated on 27/09/2005 and displayed until 26/11/2008
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 22/08/2001 and displayed until 27/09/2005
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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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