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Oilatum Emollient 63.4% w/w Bath Additive

  • Name:

    Oilatum Emollient 63.4% w/w Bath Additive

  • Company:
    info
  • Active Ingredients:

    Light Liquid Paraffin

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/10/19

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Summary of Product Characteristics last updated on medicines.ie: 10/7/2015
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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

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1 - 0 of 53 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 3 October 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 29 April 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 April 2016 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 10 July 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 10 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 22 May 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.8 - Addition of HPRA reporting statement

Updated on 22 May 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 8 July 2014 PIL

Reasons for updating

  • Change of licence holder

Updated on 6 December 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Changes to Section 7 MA Holder -

Current:

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Previous:

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Section 8: New PA no:

PA 0678/113/001   

Updated on 7 June 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

This approval was for the official addition of ‘Trading as Stiefel’ to the end of the MAH address in section 7.

Updated on 18 August 2011 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 August 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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 May 2010 SmPC

Reasons for 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

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 August 2009 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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 March 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Updated on 30 August 2006 SmPC

Reasons for 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

Legal category: Supply through pharmacy only

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 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only