NIZORAL Shampoo Ref.[6933] Active ingredients: Ketoconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK

Product name and form

Nizoral 2% shampoo.

Pharmaceutical Form
Pink viscous shampoo.

Qualitative and quantitative composition

Ketoconazole 2% w/w (each gram contains 20 mg).

For a full list of excipients, see 6.1.

Active Ingredient	Description
Ketoconazole	Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes.

List of Excipients
Sodium lauryl ether sulfate Disodium monolauryl ether sulphosuccinate Coconut fatty acid diethanolamide Laurdimonium hydrolysed animal collagen Macrogol 120 methyl glucose dioleate Sodium chloride Concentrated hydrochloric acid Imidurea Sodium hydroxide Erythrosine sodium Water purified (Ph. Eur)

Pack sizes and marketing

High density polyethylene bottles, containing 120 ml shampoo.

Marketing authorization holder

Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK

Marketing authorization dates and numbers

PL 00242/0139

Date of first authorisation: 18 April 1988
Date of renewal of authorisation: 24 June 2008

Drugs

Drug	Countries
NIZORAL	Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Finland, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States

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