Skip to content
SPC Logo

Dovobet gel

Last Updated on eMC 09-Dec-2016 View document  | Leo Laboratories Limited 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 09-Dec-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 08-Dec-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2 - minor typographical correction.
Section 4.8 Undesirable Effects - "
hair colour changes" added with frequency "Not known" and comment "
Transient discolouration of the hair at scalp application site, to a yellowish colour in white or grey hair, has been reported."   
Section 10 Date of revision updated

Updated on 21-Dec-2015 and displayed until 09-Dec-2016

Reasons for adding or updating:

  • Change to section 6.1 - List of excipients
  • 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-Dec-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- In section 6.1 (list of excipients), the number "11" has been removed from the excipient Polyoxypropylene stearyl ether
- In Section 6.5 (nature and contents of container), new pack sizes 80 g and 2 x 80 g have been added
- the date of revision is updated

Updated on 06-Aug-2015 and displayed until 21-Dec-2015

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 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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: 10-Feb-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:


  • In Sections 2, 4.2, 6.3, 6.4 and 6.5, information on the Dovobet Gel Applicator has been added.
  • In Section 10 the date of revision has been updated.

Updated on 29-Oct-2014 and displayed until 06-Aug-2015

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 19-Oct-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.3 - contraindications in syphilis, perianal and genital pruritus are removed (but warning about use on genitals remains)

Section 4.4 - local adverse reactions in relation to accidental administration to the eye have been removed (they are included in         section 4.8).  No experience of concurrent use with other antipsoriatic drugs amended to "limited experience". 
Section 4.6 - new statement that "less than 300 pregnancy outcomes" have been studied

Section 4.8 - section fully revised in line with study/post marketing data and new table of adverse events included.  Number of           patients treated and % experiencing an AE is no longer included (not required in SmPC guideline).  Adverse event are grouped          under new subheadings in the tables. New uncommon side effect: Skin infection.  New rare side effects: hypersensitivity, skin striae, skin exfoliation, rebound effect
Section 4.9 - symptoms of hypercalcaemia revised

Section 5.3 - statements regarding new non-clinical carcinogenicity studies (showing no special risk to humans) added
Section 10 - revision date updated

Updated on 17-Jul-2014 and displayed until 29-Oct-2014

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 14-Jul-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- In Section 4.2, 4.8 and 5.1 statements regarding use in adolescents have been added
- In Section 10 the date of revision has been updated

Updated on 07-Nov-2013 and displayed until 17-Jul-2014

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 03-Oct-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- In section 2 butylated hydroxytoluene is renamed to buylhydroxytoluene (E321) and QRD template changes are made.
- In section 4.4 butylated hydroxytoluene is renamed to buylhydroxytoluene.
- In section 4.8 a statement regarding reporting side effects is added.
- In section 6.1 polyoxypropylene-15 stearyl ether is renamed to polyoxypropylene-11 stearyl ether
- The revision date is updated.

Updated on 21-May-2013 and displayed until 07-Nov-2013

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: 13-May-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- In section 6.5 (nature and contents of container), a new pack size of 3x60g has been added.

Updated on 28-Mar-2012 and displayed until 21-May-2013

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: 27-Jan-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:


  • In section 7 the Marketing Authorisation Holder name has been changed from LEO Pharmaceutical Products Ltd. A/S to LEO Pharma A/S.
  • In section 10 the Date of Revision of the Text has been updated.

Updated on 22-Dec-2010 and displayed until 28-Mar-2012

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - 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. 6 - Instructions for use, handling and disposal

Date of revision of text on the SPC: 12-Dec-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

changes to SmPC following harmonisation procedure

Updated on 15-Sep-2010 and displayed until 22-Dec-2010

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Leo Laboratories Limited

Company image
Address

Horizon, Honey Lane, Hurley, Berkshire, SL6 6RJ, UK

Medical Information e-mail
Telephone

+44 (0)1844 347 333

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

betamethasone dipropionate, calcipotriol monohydrate

Legal categories

POM - Prescription Only Medicine

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue