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Dithrocream

  • Name:

    Dithrocream

  • Company:
    info
  • Active Ingredients:

    Dithranol

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/12/14

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Summary of Product Characteristics last updated on medicines.ie: 31/8/2018

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Dermal Laboratories Limited

Dermal Laboratories Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Dithrocream Active Ingredients Dithranol
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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 31 August 2018 SPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

File format updated to PDF

Updated on 10 July 2015 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 10 July 2015 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.8 Undesirable effects, the following text has been added: "Some skin irritation and/or a feeling of warmth at the site of application is normally associated with dithranol therapy."

In section 10 Date of revision of the text, the date has changed to "June 2015".

Updated on 15 December 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 December 2014 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.8 Undesirable effects, the following text has been added:

"Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.  Website: www.hpra.ie; E-mail:medsafety@hpra.ie."

In section 10 Date of revision of the text, the date has changed to "October 2014"

Updated on 15 December 2014 PIL

Reasons for updating

  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.
  • Removal/change of distributor

Updated on 8 February 2013 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.4 (Special warnings and precautions for use), the following text has been added:

"After use on the scalp, a shampoo may be used to remove the Dithrocream residue.  Great care must be taken when washing out the shampoo (which may contain some Dithrocream residue), to ensure that it does not get into the eyes or on the face.  This is particularly important when the higher strengths of Dithrocream have been used".

In section 10 (Date of revision of the text), the date has changed to "January 2013".

Updated on 20 December 2012 SPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 9 (Renewal of the Authorisation) the date for 1.0% has changed to "17 April 2010"

In section 10 (Date of revision of the text) the date has changed to "October 2012"

Updated on 19 December 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 25 August 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 29 August 2007 SPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 9 - Renewal of the Authorisation - The date has changed from '3 July 2002' to '3 July 2007'
 
Section 10 - Date of Revision of the Text - The date has changed from 'August 2006' to 'July 2007'

Updated on 29 August 2007 PIL

Reasons for updating

  • Change to date of revision

Updated on 13 August 2007 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.5 - Nature and contents of container: The text 'These are supplied as original packs (OP)' has been removed.

Updated on 25 August 2006 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.1 - Therapeutic Indications: Text added "Dithrocream has been developed as a cream formulation of dithranol for particular convenience for home treatment, and is especially suitable for the exposed surfaces and hairy regions of the body."
 

Updated on 7 February 2006 SPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 16 August 2005 SPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 27 July 2005 SPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 7 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)