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Brevoxyl 4% Cream

Last Updated on eMC 08-Apr-2016 View document  | GlaxoSmithKline Consumer Healthcare Contact details

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 08-Apr-2016 and displayed until Current

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: 09-Mar-2016

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to section 7 and 10 of the SPC.

Updated on 19-Aug-2014 and displayed until 08-Apr-2016

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC: 09-Apr-2013

Legal Category:P

Black Triangle (CHM): NO

Updated on 31-Mar-2014 and displayed until 19-Aug-2014

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC: 25-Mar-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 Trading style amended from Stiefel to Beecham Group Plc trading as Stiefel

Updated on 11-Jun-2013 and displayed until 31-Mar-2014

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 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • 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

Date of revision of text on the SPC: 09-Apr-2013

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2 Addition of 'also contains cetyl alcohol, stearyl alcohol and propylene glycol alginate'
Section 4.2 Section reworded and information on what to do if skin peeling occurs, and duration for maximum lesion reduction added. 
Section 4.3 warning reworded
Section 4.4 Addition of warning regarding excessive application and concomitant topical acne therapy  Addition of warning regarding severe irritancy.
Section 4.5 Further information regarding the warning not to use alongside other topical therapy added.  Addition of warning regarding topical sulphonamides.
Section 4.6 Previously section advised safety was not established.  Information on effects during pregnancy and lactation added.
Section 4.8 Section reformatted to classify frequency of adverse events
Section 4.9 Previously no information in this section.  New information added.
Section 5.1 addition of pharmacotherapeutic group.  Section reworded and reformatted
Section 5.2 Section reworded
Section 5.3 Information on rat studies added, and information regarding carcinogenicity.

Updated on 25-Apr-2013 and displayed until 11-Jun-2013

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC: 09-Apr-2013

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.5 - change in the composition for one of the closure systems with an alternative polyethylene cap and the removal of the external coating

Updated on 12-Mar-2013 and displayed until 25-Apr-2013

Reasons for adding or updating:

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC: 01-Mar-2013

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.1 - excipient brand names Promulgen G and DUB SC20G replaced with generic names stearyl alcohol and macrogol cetostearly ether.
Minor editorial error in section 2 corrected.

Updated on 05-Mar-2013 and displayed until 12-Mar-2013

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: 01-Mar-2013

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to sections 7 and 8 to reflect change in MAH to Steifel, 980 Great West Road, Brentford.

Updated on 25-Oct-2012 and displayed until 05-Mar-2013

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 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • 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. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 04-Oct-2012

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

2.     Update to excipient guideline requirements
4.2   Safety update to align with CDS plus additional information on directions for use
4.3   QRD template update
4.4   Safety update to align with CDS
4.5   Safety update to align with CDS
4.6   Safety update to align with CDS
4.8   Safety update to align with CDS
4.9   Safety update to align with CDS
5.1   Safety update to align with CDS
5.2   Safety update to align with CDS
5.3   Safety update to align with CDS
6.5   Editorial changes
6.6   Editorial changes
10.   Updated with new date of revision of text

Updated on 25-Jan-2011 and displayed until 25-Oct-2012

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-Jul-2010 and displayed until 25-Jan-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-Nov-2009 and displayed until 21-Jul-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-Jan-2009 and displayed until 23-Nov-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-Sep-2006 and displayed until 15-Jan-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: 01-Sep-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-Sep-2005 and displayed until 21-Sep-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-Aug-2001 and displayed until 27-Sep-2005

Reasons for adding or updating:

  • No reasons supplied

Updated on 23-Aug-2000 and displayed until 20-Aug-2001

Reasons for adding or updating:

  • No reasons supplied

Company contact details

GlaxoSmithKline Consumer Healthcare

Company image
Address

980 Great West Road, Brentford, Middlesex, TW8 9GS

Medical Information e-mail
Medical Information Direct Line

0800 783 8881

Customer Care direct line

0800 783 8881

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?

Active ingredients

benzoyl peroxide

Legal categories

P - Pharmacy

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