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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 Emollient 63.4% w/w 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:   14-Jan-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 11/05/2010 and displayed until 18/08/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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:   01-Mar-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


Section 6.1 has been updated to include Macrogol 400 dilaurate instead of polyethylene glycol 400.

section 4.2 is updated to include special populations (elderly, children) "Oilatum Emollient is indicated for use in adults (including the elderly), children and infants’.

Section 4.4:  the following statements have been added : Patients should be advised to use care to avoid slipping in the bath. Avoid contact with eyes. If a rash or skin irritation should occur, stop using the product and consult your doctor

4.3 Contraindications: ‘Hypersensitivity to the active substance or any of the excipients’

 

 

 
Updated on 15/08/2009 and displayed until 11/05/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Jul-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
In section 7, the address of the Marketing Authorisation Holder has been changed.

In section10, the date of approval has been updated.
Updated on 17/03/2007 and displayed until 15/08/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 30/08/2006 and displayed until 17/03/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • 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:   07/2006
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
section 2 A reference has been inserted "For excipients, see 6.1"
 
section 3 From "Liquid Bath Additive" to "Bath Additive". A description of the product's appearance has also been added.
 
section 6.2 Wording has been changed but the meaning stays the same.
 
section 6.4 Wording has been changed but the meaning stays the same. 
 
section 9 Date updated after a recently approved renewal.
 
section 10 Date updated after a recently approved renewal. 
Updated on 24/06/2003 and displayed until 30/08/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Light Liquid Paraffin