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Daktarin 2% w/w Cutaneous Powder

*
Pharmacy Only: Non-prescription

  • Company:

    Kenvue

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Miconazole Nitrate

    *Additional information is available within the SPC or upon request to the company

  • updated_daktarin_powder_20g.jpeg

Updated on 09 June 2024

File name

ie-pl-daktarin-powder-2414.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 09 June 2024

File name

ie-spc-v6-daktarin-powder-2414.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 17 June 2019

File name

DKE02 1668 SPC V5.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Updated on 25 January 2018

File name

PIL_10432_381.pdf

Reasons for updating

  • New PIL for new product

Updated on 25 January 2018

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 23 January 2018

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 23 January 2018

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

 

PA Transfer from McNeil Healthcare (Ireland) Ltd to Johnson & Johnson (Ireland) Ltd. Change in PA number. Note the address and contact details remain the same.

Updated on 19 January 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.8

 

 

Angioedema moved from SOC "Immune System Disorders" to Skin and "subcutaneous Tissue Disorders"

Updated on 19 November 2015

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.3

Hypersensitivity to the active substance, other imidazole derivatives or to any of the excipients listed in section 6.1.

Section 4.4

Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with miconazole topical formulations. If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued. Daktarin Powder must not come into contact with the mucosa of the eyes.

Miconazole PRAC updates SNAS 1409

Section 4.8- addition of AE reporting details

Updated on 18 November 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Addition of information on reporting a side effect.

Updated on 24 June 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Additonal side effects and revised overdosage section.

Updated on 18 April 2013

Reasons for updating

  • Change due to user-testing of patient information

Updated on 12 August 2010

Reasons for updating

  • Change of manufacturer

Updated on 02 November 2009

Reasons for updating

  • Change to marketing authorisation holder

Updated on 29 October 2009

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

MA Holder changed to McNeil Healthcare Ireland Limited. MA Number changed to PA 823/59/2

Updated on 12 May 2009

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text
  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company



1.

NAME OF THE MEDICINAL PRODUCT

Changed to Daktarin  2% w/w Cutaneous Powder from Daktarin Powder

 

 

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Addition of 20mg/g

 

Full statement  added: For a full list excipients, see section 6.1.

6.1

List of excipients

 E number added to talc

Name corrected : Silica, colloidal anhydrous

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Renewal of product licence  March 2008

10.

DATE OF REVISION OF THE TEXT

 

Changed to May 2009 November 2006

 

Updated on 11 May 2009

Reasons for updating

  • Change to date of revision
  • Change of trade or active ingredient name
  • Change of inactive ingredient
  • Change to storage instructions

Updated on 04 October 2007

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Change to section 6.3 - shelf life - reduced from 5 to 3 years.
Change to section 10 - date of revision - September 2007

Updated on 11 April 2006

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 20 March 2006

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Legal category:Supply through pharmacy only

Updated on 05 October 2005

Reasons for updating

  • Change of manufacturer
  • Correction of spelling/typing errors

Updated on 22 September 2005

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Updated on 22 September 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 05 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only