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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 Polytar Liquid 1% w/w Shampoo

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:   03-Dec-2010
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 20/01/2010 and displayed until 18/08/2011
Reasons for adding or updating:
  • Change to product name
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.3 - Preclinical safety data
  • 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:   31-Dec-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 1.0 Name changed to Polytar Liquid 1% w/w Shampoo, in line with Article 11 of Directive 2001/83 EEC.

Section 2.0 The following were added:

(Arachis Oil*)
* also known as peanut oil added

For a full list of excipients, see section 6.1

Section 4.4 The following warning was added to comply with the requirements of CPMP/463/00 regarding the excipient Arachis Oil:

Polytar Liquid contains Arachis Oil (peanut oil) and should not be applied by patients known to be allergic to peanut.  As there is a possible relationaship between allergy to peanut and Soya, patients with Soya allergy should also avoid Polytar Liquid.

Section 5.3 The abbreviation (PAHs) has been expanded to Polyclclic Hydrocarbons.

Section 9.0 Date of Last renewal is 01 October 2009

Section 10.0 Date of Revision of Text is December 2009.

 

 




 
Updated on 15/08/2009 and displayed until 20/01/2010
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
Section 7: Address of Marketing Authorisation Holder changed

Section 10: Date of revision updated
Updated on 01/09/2006 and displayed until 15/08/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   07/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 3 Added - Clear brownish liquid with an odour of tar.
Section 6.1 Changed Octoxinol to Octylphenoxy Polyethoxy Ethanol
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

 
  Tar Blend