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Galderma (U.K) Ltd
Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, UK
Telephone: +44 (0) 1923 208950
Fax: +44 (0) 1923 208998
Summary of Product Characteristics last updated on medicines.ie: 03/06/2011
SPC Acnecide Gel 5%

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 03/06/2011 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:   31-May-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Addition of 30g pack size.
Updated on 04/03/2011 and displayed until 03/06/2011
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Feb-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
The shelf life of the product has been reduced from 36 months to 24 months.
Updated on 02/02/2011 and displayed until 04/03/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   25-Jan-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
The adverse events listed in section 4.8 have been presented in a table accroding to system organ class and frequency of occurence. Some additional adverse events have also been added to the table in section 4.8.
Updated on 25/02/2008 and displayed until 02/02/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update to section 4.4 - Special Warnings and Special Precautions for Use
Updated on 30/08/2006 and displayed until 25/02/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   05/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 7 Change of office address from Galderma House, Church Lane, Kings Langley, Herts, WD4 8 JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS
Updated on 16/06/2003 and displayed until 30/08/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Benzoyl Peroxide, hydrous