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McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
Medical Information Direct Line: 01344 864042
Medical Information e-mail: medinfo@its.jnj.com

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: 28/04/2011
SPC Nizoral Dandruff Shampoo

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 28/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • 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:   15-Apr-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To make a minor change to section 4.8 (Undesirable effects) and to update section 4.6 (Pregnancy and lactation) to remove reference to section 5.3.
Updated on 13/04/2011 and displayed until 28/04/2011
Reasons for adding or updating:
  • 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:   22-Mar-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


update to SPC section 5.3 Preclinical safety data
Updated on 21/03/2011 and displayed until 13/04/2011
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08-Mar-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to section 4.6 Pregnancy and lactation of the SmPC

Ketoconazole

Updated on 26/08/2010 and displayed until 21/03/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Aug-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Nature of change: To update section 4.8 (Undesirable effects) of the SPC, to include hypersensitivity and angioedema.
Updated on 17/06/2010 and displayed until 26/08/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Jun-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change:

Update to section 4.8 (Undesirable effects) of the SPC.
Updated on 30/03/2010 and displayed until 17/06/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-Feb-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to 6.5 removal of sachets.
Updated on 22/03/2010 and displayed until 30/03/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-Feb-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Changes to section 4.4 and 4.9
Updated on 26/01/2010 and displayed until 22/03/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Jan-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change – to section 6.5 nature and contents of container – deletion of all reference to sachets
Updated on 05/02/2009 and displayed until 26/01/2010
Reasons for adding or updating:
  • Joint SPC superseded by SPCs for individual presentations
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   21-Jan-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
To update section 4.8 in line with SmPC guidelines.
To provide separate SmPCs for Nizoral Dandruff Shampoo (P) and Nizoral Antidandruff Shampoo (GSL).
Updated on 15/12/2008 and displayed until 05/02/2009
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2008
Legal Category:   P, GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 10 – Date of revision of the text

December 2008

Change to section 4.6 – Pregnancy and Lactation

New information:

There are no adequate and well-controlled studies in pregnant or lactating women. To date, no other relevant epidemiological data are available. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity following oral administration of ketoconazole. (see Preclinical safety data, section 5.3). No effects on the breastfed newborn/infant are anticipated. See Pharmacokinetic properties, section 5.2

 

 

 

 
Updated on 20/10/2008 and displayed until 15/12/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   01-Sep-2008
Legal Category:   P, GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


X

Change to section 4.3 – Contra-indications
Updated information
Updated on 23/09/2008 and displayed until 20/10/2008
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2008
Legal Category:   P, GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


X

Change to section 5.2 - Pharmacokinetic properties
Updated information

X

Change to section 10 – Date of revision of the text

September 2008
Updated on 18/06/2007 and displayed until 23/09/2008
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 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 1 –Name of the medicinal product

Removed TM

Change to section 2 – quantitative and qualitative composition

For excipients, see 6.1

Change to section 3 – pharmaceutical form

Shampoo

Change to section 10 – Date of revision of the text

June 2007
Updated on 27/11/2006 and displayed until 18/06/2007
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 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • 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:   11/2006
Legal Category:   GSL/P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.4

Special Warnings and Precautions for Use

Add in new paragraph about gradual withdrawal.

4.5

Interaction with other medicinal products and other forms of interaction

Delete paragraph replace with None Known

4.8

Undesirable effects

Add sentence about alopecia

6.4

Special precautions for storage

Change heading

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of Renewal 16th September 2005

10.

DATE OF REVISION OF THE TEXT

The date here should be November 2006

 
Updated on 27/02/2006 and displayed until 27/11/2006
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
  • Correction of spelling/typing errors
Updated on 20/02/2003 and displayed until 27/02/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text

Active Ingredients/Generics

 
  ketoconazole