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Stiefel
Stockley Park West, , Uxbridge, Middlesex, UB11 1BT , UK
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: 25/01/2011
SPC Brevoxyl 4% 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 25/01/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Jan-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 -

GlaxoSmithKline UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS

Trading as Stiefel
Stockley Park West
Uxbridge
Middlesex
UB11 1BT


Section 8 - PL 19494/0067
Section 10 - 19 January 2011
Updated on 21/07/2010 and displayed until 25/01/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   16-Jul-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 - Reduction of shelf life from 24 months to 18 months
Updated on 23/11/2009 and displayed until 21/07/2010
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:   17-Nov-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7: Change to address of MAH

Section 10: Date updated.
Updated on 15/01/2009 and displayed until 23/11/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   28-May-2006
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 (special warnings and special precautions for use): correction of typo

Section 4.8 (Undesirable effects): Correction: insertion of missing word (pruritus)

Section 6.1 (List of excipients): Correction: Promulgen G (Stearyl alcohol and macrogol cetostearyl ether)

Section 6.2 (incompatibilities): Correction: Not applicable 

Section 6.3 (Shelf life): Correction:after first opening statement deleted

Section 6.6 (instructions for use and handling): Correction: No special requirements

Section 9 (date of first authorisation......): Date of first authorisation was missing and has been inserted.
Updated on 21/09/2006 and displayed until 15/01/2009
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 Name corrected to Brevoxyl 4% Cream
 
Section 4.4 Addition of missing warning 'Propylene glycol alginate may cause skin irritation. Steryl alcohol and cetyl alcohol may cause local skin reaction (e.g. contact dermatitis).'
 
Section 4.8 Deletion of pruritis as an undesirable effect as it does not appear in the licenced SPC
 
Section 6.1 Macrogol cetostearyl ether corrected to Ceteareth-20
 
Section 6.3 Addition of shelf life instruction to comply with expiry date
 
Section 6.5 Correction of 'Lacquered aluminium or laminated (aluminium/plastic) tubes...' as per licenced SPC
 
Section 9 Last renewal was 28 May 2006
 
Section 10 Revision of text was 28 May 2006
Updated on 27/09/2005 and displayed until 21/09/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 3 - pharmaceutical form
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 20/08/2001 and displayed until 27/09/2005
Reasons for adding or updating:
  • No reasons supplied
Updated on 23/08/2000 and displayed until 20/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
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