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McNeil Healthcare (Ireland) Ltd
Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 5316
Summary of Product Characteristics last updated on medicines.ie: 29/10/2009
SPC Daktarin 2% w/w Cutaneous Powder

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 29/10/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   31-Aug-2009
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 12/05/2009 and displayed until 29/10/2009
Reasons for adding or 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
Date of revision of text on the SPC:   01-May-2009
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 04/10/2007 and displayed until 12/05/2009
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2007
Legal Category:   prescription 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 20/03/2006 and displayed until 04/10/2007
Reasons for adding or 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
Updated on 22/09/2005 and displayed until 20/03/2006
Reasons for adding or 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
Updated on 05/06/2003 and displayed until 22/09/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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