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Diomed Developments Limited
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
Telephone: +44 (0)1462 458 866
Fax: +44 (0)1462 420 565
WWW: http://www.dermal.co.uk

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: 18/08/2009
SPC 4head Cutaneous Stick

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 18/08/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jan-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 9 (Renewal of the Authorisation) the date has changed to "12 January 2009"

In section 10 (Date of revision of the text) the date has changed to "January 2009"
Updated on 01/12/2008 and displayed until 18/08/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • 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 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-Aug-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects), the following text has been added: "Because levomenthol is volatile, in rare cases it may cause temporary, mild watering of the eyes".

In section 6.3 (shelf-life), the text has changed to "60 months".

In section 6.4 (special precautions for storage), the following text has been added: "(Melts at about 43 degrees C)".

In section 6.5 (nature and contents of container), the following text has been deleted: "This is supplied as an original pack (OP)".

In section 6.6 (special precautions for disposal and other handling), the following text has been added: "For single patient use only".

In section 10 (date of revision of the text), the date has changed to "August 2008".
Updated on 29/01/2007 and displayed until 01/12/2008
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  levomenthol