Oilatum Plus Bath Additive

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: 26/10/2017
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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 26 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 26 October 2017 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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In section 6.5, urea cap has been replaced by a polypropylene cap
In section 10, the date of revision has been updated

Updated on 3 May 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 May 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 22 May 2015 PIL

Reasons for updating

  • Change to side-effects

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 8 July 2014 PIL

Reasons for updating

  • Change of licence holder

Updated on 27 February 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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 7 has been changed from GlaxoSmithKline (Ireland) Ltd. to GlaxoSmithKline Consumer Healthcare Limited

Section 8 has been changed from PA 1077/126/2 to PA 678/115/2

Section 10 has been updated to February 2013

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 23 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 19 August 2011 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 14 September 2010 SmPC

Reasons for 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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 1 Name of the medicinal Product the following actives were added:

 

1.     NAME OF THE MEDICINAL PRODUCT

 

Oilatum Plus Bath Additive

Light liquid paraffin 52.5% w/w

Benzalkonium chloride 6.0% w/w

Triclosan 2.0% w/w

In section 7 the address of the MAH was updated:

7.     MARKETING AUTHORISATION HOLDER

 

        Stiefel Laboratories (UK) Ltd

        Eurasia Headquarters

        Concorde Road

        Maidenhead

        Berks  SL6 4BY

        United Kingdom

In section 9 the date of renewal was updated

9.     DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION

 

        Date of first authorisation: 25 May 1989

 

        Date of last renewal: 25 May 2009


In section 10 the date of revision of the text

 

10.   DATE OF REVISION OF THE TEXT

 

        August 2010

 

 

 

 

 

 

Updated on 28 August 2007 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change of word from persists to persistent in Section 4.9

Updated on 30 August 2006 SmPC

Reasons for 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 6.1 - List of excipients
  • 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 1 From Oilatum Plus to Oilatum Plus Bath Additive

 

Section 2 Benzalkonium chloride is now quoted as neat rather than 50% solution, formulation remains exactly the same. Also a reference to section 6.1 is inserted.

 

Section 4.6 Wording correction “Pregnancy or …” becomes “pregnancy and lactation”

 

Section 6.1 ingredients lowercased, composition remains the same.

 

Section 6.2 Wording change, meaning remains the same.

 

Section 6.4 Wording change, meaning remains the same.

 

Section 9 Dates changed following recent renewals/ variations

 

Section 10 Dates changed following recent renewals/ variations

Updated on 24 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only