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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 17/12/2008
SPC Daktarin Cream

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 17/12/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08-Dec-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 9 – Date of Renewal of Authorisation

08 December 2008

Change to section 10 – Date of revision of the text

Changed from 26th June 2008 to 08 December 08
Updated on 01/07/2008 and displayed until 17/12/2008
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   26-Jun-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 7 – Marketing Authorisation Holder

New address:

 

50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Change to section 8 – Marketing Authorisation Numbers

 

Change to section 9 – Date of Renewal of Authorisation

 

Change to section 10 – Date of revision of the text

Changed form 10th March 2008 to 26th June 2008
Updated on 18/03/2008 and displayed until 01/07/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 1 –Name of the medicinal product

Daktarin Cream

 

Change to section 2 – quantitative and qualitative composition

Miconazole Nitrate Ph.Eur 2.0% w/w

(Each gram of cream contains 20mg of miconazole nitrate)

 

For excipients, see Section 6.1

 

 

Change to section 3 – pharmaceutical form

Cream

White homogeneous cream

 

Change to section 6.4 – Special Precautions for Storage

 

Change to section 6.5 – Nature and Contents of Container

*Not all pack sizes may be marketed.

Change to section 6.6 –  Instructions for use, handling and disposal

 

Change to section 10 – Date of revision of the text

 10th  March 2008

 

 
Updated on 19/12/2007 and displayed until 18/03/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 6.1 – List of Excipients

 PEG-6, PEG-32 and glycol stearate
 Oleoyl macroglycerides

 

Change to section 10 – Date of revision of the text

 14th December 2007
Updated on 22/01/2007 and displayed until 19/12/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • 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
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

REASON(S) FOR SUBMISSION

 

Change

eMC - Summary of Change Details Per Section

 

Change to section 4.4 – Special Warnings and Precautions for Use

addition of wording re sensitivity

Change to section 4.6 – Pregnancy and Lactation

new sub-heading to paragraph on pregnancy and addition of paragraph re lactation

Change to section 4.7 - Effects on Ability to Drive and Use Machines

minor wording change only

Change to section 4.8 – Undesirable effects

post marketing data added and information expanded

Change to section 4.9 - Overdose

description of symptoms added

Change to section 5.1 - Pharmacodynamic properties

Pharmacotherapeutic classification and ATC code added

Change to section 5.2 - Pharmacokinetic properties

wording changed to present three distinct subparagraphs: ‘Absorption’, ‘Distribution’ and ‘Metabolism and Excretion’

Change to section 5.3 - Preclinical Safety Data

Reference to Preclinical data added

Change to section 10 – Date of revision of the text

12 January 2007
Updated on 20/06/2006 and displayed until 22/01/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 4.3 - Contra-indications 'None' changed to '[Name] is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient in this product.'

Change to section 10 (date of revision of the text)

Updated on 20/06/2006 and displayed until 20/06/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 4.3 - Contra-indications 'None' changed to '[Name] is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient in this product.'

Change to section 10 (date of revision of the text)

Updated on 26/08/2004 and displayed until 20/06/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 6. 3 - Shelf Life
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/08/2001 and displayed until 26/08/2004
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  miconazole nitrate