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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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Summary of Product Characteristics last updated on the eMC: 21/07/2010
SPC Canesten HC 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 4.3 - Contraindications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   02-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


- To update section 4.3 (Contraindications) of the SPC to add hypersensitivity to cetostearyl alcohol

- To update section 4.8 (Undesirable effects) of the SPC to include blisters, oedema and peeling of skin using MedDRA terminology

- To update section 5.2 (Pharmacokinetic Properties) of the SPC to improve clarity of information

Updated on 02/09/2005 and displayed until 21/07/2010
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/06/2004 and displayed until 02/09/2005
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 02/09/2003 and displayed until 30/06/2004
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/02/2002 and displayed until 02/09/2003
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 25/09/2001 and displayed until 20/02/2002
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 4.1 - Therapeutic Indications
Updated on 25/07/2001 and displayed until 25/09/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 18/12/2000 and displayed until 25/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  hydrocortisone
  clotrimazole