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Galderma (U.K) Ltd

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: 22/09/2009
SPC Differin Gel

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 22/09/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

In section 4.6, The pregnancy warnings have been updated.
Updated on 06/08/2008 and displayed until 22/09/2009
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to the date of revision of the text

Updated on 27/05/2008 and displayed until 06/08/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update to section 4.8 of SPC
 
Update to excipients listing in section 2
Updated on 01/03/2007 and displayed until 27/05/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   10/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 7 - change to office address of marketing authorisation holder
Updated on 28/09/2005 and displayed until 01/03/2007
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Updated on 23/05/2005 and displayed until 28/09/2005
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Updated on 28/05/2004 and displayed until 23/05/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Updated on 16/06/2003 and displayed until 28/05/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Adapalene

Versions

 
22/09/2009 to Current
06/08/2008 to 22/09/2009
27/05/2008 to 06/08/2008
01/03/2007 to 27/05/2008
28/09/2005 to 01/03/2007
23/05/2005 to 28/09/2005
28/05/2004 to 23/05/2005
16/06/2003 to 28/05/2004
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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