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Leo Laboratories Limited
Longwick Road, Princes Risborough, Bucks., HP27 9RR
Telephone: +44 (0)1844 347 333
Fax: +44 (0)1844 276 385
Medical Information e-mail: medical-info.uk@leo-pharma.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: 05/11/2010
SPC Dovonex 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 05/11/2010 and displayed until Current
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 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   01-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updates in line with the company core safety information.
Updated on 08/12/2009 and displayed until 05/11/2010
Reasons for adding or updating:
  • 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:   01-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


6.1                 List of excipients

            Macrogol cetostearyl ether, cetostearyl alcohol, chloroallylhexaminium chloride, disodium edetate, disodium phosphate dihydrate, glycerol 85%, liquid paraffin, sodium hydroxide, purified water, white soft paraffin.

The excipient Sodium Hydroxide has been added to the list of excipients within Section 6.1 of the SPC for Dovonex Cream.

10             DATE OF REVISION OF THE TEXT

          October 2008   March 2009

The date of revision has been changed due to the chnages made in section 6.1 of the SPC.


 
Updated on 28/10/2008 and displayed until 08/12/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.2 - Incompatibilities
  • 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:   01-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.8, undesirable effects have been updated to include frequency details.
Other sections have been updated with the aim of achieving consistency across the product range.
Updated on 18/05/2007 and displayed until 28/10/2008
Reasons for adding or updating:
  • 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 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4: Addition of warning re exposure to sunlight.
Section 4.5: Amendment to wording.
Scetion 5.3: Information from new studies added.
Updated on 30/08/2005 and displayed until 18/05/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 27/07/2005 and displayed until 30/08/2005
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 10/11/2003 and displayed until 27/07/2005
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 01/05/2002 and displayed until 10/11/2003
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 24/07/2001 and displayed until 01/05/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 25/02/2000 and displayed until 24/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 28/01/2000 and displayed until 25/02/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 28/01/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  calcipotriol hydrate