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Stiefel Ireland
GlaxoSmithKline (Ireland) Ltd, Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: +353 1 800 244 255
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 18/08/2011
SPC Oilatum Junior Emollient Bath Additive

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 18/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   04-Mar-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
 Transfer of Marketing Authorisation from Stiefel Laboratories (UK) Ltd to GSK (Ireland) Ltd (Trading as Stiefel).
Updated on 31/05/2011 and displayed until 18/08/2011
Reasons for adding or updating:
  • Change to section 8 - MA number
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   04-Mar-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


The reason for change is the transfer of the licence from ‘Stiefel Laboratories (UK) Ltd’ to ‘GlaxoSmithKline (Ireland) Ltd, Trading as Stiefel’, affecting Section 7 of the SPC, and the change of the PA number from ‘PA 144/22/4’ to ‘PA 1077/125/3’, affecting section 8
Updated on 18/02/2010 and displayed until 31/05/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 7 - Marketing authorisation holder
  • 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:   27-Nov-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 1: Name updated to Oilatum Junior Emollient Bath Additive
Section 7: Change of MAH address
Section 9: Date of renewal updated
Section 10: Date of revision of text updated.
Updated on 01/09/2006 and displayed until 18/02/2010
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   06/2005
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 6.1 Changed Acetylated Wool Alcohols to Acetylated Lanolin Alcohols
Updated on 16/08/2005 and displayed until 01/09/2006
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Light liquid paraffin