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Dermal Laboratories Limited

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: 24/10/2008
SPC Nicam 4% w/w Gel

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 24/10/2008 and displayed until Current
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:   09/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 6.1 (List of excipients) : The following changes have been made: "Polyoxyethylene Lauryl Ether" has changed to "Macrogol Lauryl Ether" and "Ethanol" has changed to "Ethanol Anhydrous".
 
Section 10 (Date of revision of the text) : The date has changed to "September 2008".
Updated on 22/07/2008 and displayed until 24/10/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   01/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 1 - Name of the medicinal product: The strength and pharmaceutical form have been added to the name, as follows: "Nicam 4% w/w Gel" 
 
Section 9 - Renewal of the Authorisation: The renewal date has changed to: "13 October 2007"
Updated on 13/08/2007 and displayed until 22/07/2008
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   08/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 6.5 - Nature and contents of container: The text 'This is supplied as an original pack (OP)' has been removed.
Updated on 21/07/2005 and displayed until 13/08/2007
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Updated on 12/03/2004 and displayed until 21/07/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Updated on 13/06/2003 and displayed until 12/03/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Nicotinamide

Versions

 
24/10/2008 to Current
22/07/2008 to 24/10/2008
13/08/2007 to 22/07/2008
21/07/2005 to 13/08/2007
12/03/2004 to 21/07/2005
13/06/2003 to 12/03/2004
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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