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Dermal Laboratories Limited
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR , UK
Telephone: +44 (0)1462 458 866
Fax: +44 (0)1462 420 565
Summary of Product Characteristics last updated on medicines.ie: 22/07/2009
SPC Emulsiderm Emollient Bath Additive/Cutaneous Emulsion

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 22/07/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
In section 4.8 (Undesirable effects) the following text has been added: "Although the emollient has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction discontinue treatment.  These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic/hypersensitive in nature.  Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area."

In section 10 (Date of revision of the text) the date has changed to: "June 2009"
Updated on 29/05/2009 and displayed until 22/07/2009
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Apr-2009
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
In section 1 (Name of the medicinal product) : the name has changed from "Emulsiderm Emollient" to "Emulsiderm Emollient Bath Additive/Cutaneous Solution"

In section 9 (Renewal of the Authorisation) : the date has changed to "21 February 2009"

In section 10 (Date of revision of the text) : the date has changed to "April 2009"
Updated on 13/08/2007 and displayed until 29/05/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   08/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Special warnings and precautions for use: Text has changed from 'Keep out of the reach of children' to 'Keep out of the reach and sight of children'
 
Section 6.5 - Nature and contents of container: The text 'These are supplied as original packs (OP)' has been removed.
Updated on 28/04/2004 and displayed until 13/08/2007
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 12/06/2003 and displayed until 28/04/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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