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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: 24/10/2011
SPC Rozex Cream

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 24/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Details regarding average period of treatment and continued periods of treatment added.
Section 4.4 - Cross-reference to Section 5.3 regarding carcinogenic effects added.
Section 4.5 - Details regarding disulfiram-like reactions added.
Section 4.7 - Standard wording updated
Section 4.8 - Changed formatting
Section 10 - Date updated
Updated on 09/04/2009 and displayed until 24/10/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update to section 4.2, 4.4 and 4.5.
Updated on 01/03/2007 and displayed until 09/04/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   05/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 7 - Change of address of marketing authorisation holder.
Updated on 01/09/2006 and displayed until 01/03/2007
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:   02/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 7 - Change of office address from Galderma House, Church Lane, Kings Langley, Hertfordshire, WD4 8JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS
Updated on 20/08/2003 and displayed until 01/09/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.2 - Incompatibilities
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 16/06/2003 and displayed until 20/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Metronidazole