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Stiefel Ireland
GlaxoSmithKline (Ireland) Ltd, Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: +353 1 800 244 255
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 15/05/2012
SPC Duac

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   23-Apr-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
The new SPC includes changes to section ‘6.5 Nature and Contents of Container’ where a new pack size has been added
Updated on 18/08/2011 and displayed until 15/05/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   27-May-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
 Transfer of Marketing Authorisation from Stiefel Laboratories (UK) Ltd to GSK (Ireland) Ltd (Trading as Stiefel).
Updated on 12/10/2009 and displayed until 18/08/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In Section 7.0 address of MAH has been amended to:

Stiefel Laboratories (UK) Ltd
Eurasia Headquarters
Concorde Road
Maidenhead
Berks SL6 4BY
United Kingdom
Updated on 08/02/2009 and displayed until 12/10/2009
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 1: Name changed from "Duac Once Daily Gel" to  "Duac Once Daily 10mg/g + 50mg/g Gel"
 
Section 9: Renewal date added (16 September 2008)
 
Section 10: Date updated to January 2009
 
 
Updated on 28/08/2007 and displayed until 08/02/2009
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Amended:
1) Pack sizes available
2) Date of Revision of the text
 
Updated on 06/07/2007 and displayed until 28/08/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Added:
In the post-marketing environment there have been isolated instances of allergic reactions which can be sudden and severe.
Updated on 17/03/2007 and displayed until 06/07/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 01/09/2006 and displayed until 17/03/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   07/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 2 Changed 10mg clindamycin phosphate to 10mg clindamycin
Section 5.1 Changed ATC code.  Added paragraph starting "The prevalence...
Updated on 16/08/2005 and displayed until 01/09/2006
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Clindamycin Phosphate
  Benzoyl Peroxide, hydrous