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Alliance Pharmaceuticals Ireland
United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
Telephone: + 44 (0)1249 466966
Fax: +44 (0)1249 466 977
Medical Information e-mail: medinfo@alliancepharma.co.uk
Summary of Product Characteristics last updated on medicines.ie: 01/08/2007
SPC Pentrax 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 01/08/2007 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 10- date of revision
Updated on 12/01/2007 and displayed until 01/08/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 6.1- Changes requested by the IMB following review
 
List of expients rearranged

Laureth 23 had a hyphen added so it is now Laureth-23
 
Section 9- Changes requested by the IMB following review
 
 

Section 9 was amended to read:

 

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 26 October 1995

 

Date of last renewal: 26 October 2005

 

 

In the previous version it read:

 

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

26 October 1995/26 October 2005
Updated on 05/10/2006 and displayed until 12/01/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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:   04/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 1 should now read:
 
Pentrax 4.3% w/v Shampoo
 
Section 2 should now read:
 
Fractar 5                    7.71% w/v
 
(equivalent to coal tar 4.3% w/v)     
 
For excipients, see Section 6.1
 
Section 3 should now read:
 
A burgundy-brown liquid of medium viscosity and a coal-tar odour.
 
Section 4.6 should now read:
 
The safety of Pentrax has not been established
 
Section 4.8 should now read:
 
There have been no reports of adverse effects following the use of Pentrax Shampoo. However, coal tar may cause irritation to the skin.  Erythema and hypersensitivity to coal tar has been reported.  Although carcinogenicity of coal tar has been demonstrated in animal studies, no studies demonstrating an increased risk of skin cancer with normal therapeutic use in humans have been reported.  There is no unequivocal evidence to link the use of topically applied coal tar products with skin cancer.
 
Section 6.1 should now read:
 
Dioctyl sodium sulphosuccinate
 
Laureth 23

Polyethylene glycol 8

Sodium lauryl sulphate

Cocamide DEA

Lauramine oxide      

Isopropyl myristate

Squalane
 
Section 6.4 should now read:
 
Do not store above 30ºC.
 
Section 6.6 should now read:
 
No special requirements
 
Section 9 should read:
 
26th October 1995/26th October 2005
 
Section 10 should now read:
 
April 2006
Updated on 09/08/2004 and displayed until 05/10/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Fractar 5