GlaxoSmithKline UK

Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

Summary of Product Characteristics last updated on the eMC: 25/03/2010
SPC Bactroban 2% 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 25/03/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   08-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 1 - 2% added to name

Section 4.2- Details regarding children under 1 year of age added

Section 4.4- Whole section updated
Updated on 21/05/2009 and displayed until 25/03/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   28-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.3 - Wording change to whole section

 

Section 5.1 - Additional Wording on ATC classification
Section 10 - New date

 

 

Updated on 13/12/2007 and displayed until 21/05/2009
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 6.5: To change this to:

"Squeezable aluminium tubes with a screw cap containing 15 g of white cream." (i.e. to remove reference to 1 g or 30 g tube sizes)
 
Section 10: To change from "2 May 2006" to "30 November 2007"
Updated on 16/06/2006 and displayed until 13/12/2007
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   05/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441

Updated on 14/06/2005 and displayed until 16/06/2006
Reasons for adding or updating:
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 10/03/2003 and displayed until 14/06/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 19/12/2002 and displayed until 10/03/2003
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 05/08/2001 and displayed until 19/12/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 03/05/2000 and displayed until 05/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   mupirocin calcium