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
Medical Information e-mail: info.uk@galderma.com

Summary of Product Characteristics last updated on the eMC: 21/07/2010
SPC Calmurid Cream

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 21/07/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   01-Dec-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section updated from:

A white cream containing Urea Ph.Eur 10.0 % w/w and Lactic Acid Ph.Eur 5.0% w/w in a stabilising emulsified base.

to:

One gram of cream contains 100 mg of Urea and 50 mg of Lactic acid

Name changed from:

Calmurid Cream


to:

Calmurid 10%/5% w/w Cream
Updated on 13/01/2010 and displayed until 21/07/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Dec-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

The shelf life has been reduced from 30 months to 24 months
Updated on 25/02/2008 and displayed until 13/01/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   07/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Updated to include additional 30g pack size
Updated on 06/09/2006 and displayed until 25/02/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   02/2006
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7 – Change of office address from Galderma House, Church Lane, Kings Langley, Herts, WD4 8JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS

Updated on 19/02/2002 and displayed until 06/09/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 15/08/2001 and displayed until 19/02/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 06/09/1999 and displayed until 15/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   urea
   lactic acid