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Ricesteele Manufacturing Ltd

Ricesteele Manufacturing Ltd
Unit 31, Cookstown Industrial Estate, Tallaght, Dublin 24,
Telephone: +353 1 451 0144
Fax: +353 1 452 1875
Summary of Product Characteristics last updated on medicines.ie: 23/08/2007
SPC Pedamed 100mg/g Cream

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 23/08/2007 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

NAME OF THE MEDICINAL PRODUCT Pedamed 100mg/g Cream


QUALITATIVE AND QUANTITATIVE COMPOSITION
 
Each gram of cream contains 100 mg zinc undecylenate equivalent to zinc undecylenate 10% w/w.
 
Excipients:        Bronopol 0.500 mg/g.
            Ethyl, Methyl and Propyl parahydroxybenzoates (E214, E218, E216) 1.5 mg/g.
 
For full list of excipients, see section 6.1.

PHARMACEUTICAL FORM  
Cream.  Smooth, white cream.
 
Section 6.1 Addition of Purified Water
Section 6.3 Written as 3 years
Section 10 October 2006
Updated on 25/05/2005 and displayed until 23/08/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Updated on 10/06/2003 and displayed until 25/05/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Zinc undecylenate

Versions

 
23/08/2007 to Current
25/05/2005 to 23/08/2007
10/06/2003 to 25/05/2005
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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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