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Dovonex Cream

Last Updated on eMC 05-Nov-2010 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 05-Nov-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-Dec-2009 and displayed until 05-Nov-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-Oct-2008 and displayed until 08-Dec-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-May-2007 and displayed until 28-Oct-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: 01-Feb-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-Aug-2005 and displayed until 18-May-2007

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 27-Jul-2005 and displayed until 30-Aug-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-Nov-2003 and displayed until 27-Jul-2005

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Updated on 01-May-2002 and displayed until 10-Nov-2003

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Updated on 24-Jul-2001 and displayed until 01-May-2002

Reasons for adding or updating:

  • Transferred from eMC version 1

Updated on 25-Feb-2000 and displayed until 24-Jul-2001

Reasons for adding or updating:

  • No reasons supplied

Updated on 28-Jan-2000 and displayed until 25-Feb-2000

Reasons for adding or updating:

  • No reasons supplied

Updated on 06-Sep-1999 and displayed until 28-Jan-2000

Reasons for adding or updating:

  • No reasons supplied

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

calcipotriol hydrate

Legal categories

POM - Prescription Only Medicine

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