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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

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 09/03/2012
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 09/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section

Summary of change

5.1

Added information on Pharmaceutical Group, Mode of Action, Mechanism of Resistance, and Microbiological Susceptibility.

5.3

minor format change – insertion of a dash in heading, Pre-clinical safety data

6.3

minor format change – insertion of a dash in heading, Shelf-life

10.

Updated with new date of revision/approval of text
Updated on 25/03/2010 and displayed until 09/03/2012
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

 
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