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Reckitt Benckiser Ireland Limited
7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299
Summary of Product Characteristics last updated on medicines.ie: 30/03/2011
SPC E45 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 30/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Mar-2011
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
In section 4.1 (therapeutic indication), "use as emollient adjunctive therapy in the treatment of dry cases of psoriasis" has been added.

In section 10, revison of text date changed to March 2011
Updated on 05/02/2010 and displayed until 30/03/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • 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:   25-Jan-2010
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
All changes as a result of license renwal
Updated on 21/08/2008 and displayed until 05/02/2010
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   02/2008
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Update to section 6.5 Nature and Contents of Containers
Updated on 24/04/2008 and displayed until 21/08/2008
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   02/2008
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Change to section 6.5 addition of 500g pump pack with pump piston airless dispenser.
Updated on 21/08/2007 and displayed until 24/04/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Change of MA holder and PA numer to Reckitt Benckiser Irelang Ltd
Updated on 09/06/2005 and displayed until 21/08/2007
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
Updated on 27/06/2003 and displayed until 09/06/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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