VANIQA Cream Ref.[9693] Active ingredients: Eflornithine

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain

Product name and form

Vaniqa 11.5% cream.

Pharmaceutical Form

Cream.

White to off white cream.

Qualitative and quantitative composition

Each gram of cream contains 115 mg of eflornithine (as hydrochloride monohydrate).

Excipients with known effect: Each gram of cream contains 47.2 mg of cetostearyl alcohol, 14.2 mg of stearyl alcohol, 0.8 mg of methyl parahydroxybenzoate and 0.32 mg of propyl parahydroxybenzoate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Eflornithine

Eflornithine irreversibly inhibits ornithine decarboxylase, an enzyme involved in the production of the hair shaft by the hair follicle. Eflornithine has been shown to reduce the rate of hair growth.

List of Excipients

Cetostearyl alcohol
Macrogol cetostearyl ether
Dimeticone
Glyceryl stearate
Macrogol stearate
Methyl parahydroxybenzoate (E218)
Liquid paraffin
Phenoxyethanol
Propyl parahydroxybenzoate (E216)
Purified water
Stearyl alcohol
Sodium hydroxide (E524) (to adjust pH)

Pack sizes and marketing

High density polyethylene tube with a polypropylene screw cap containing 15 g, 30 g or 60 g of cream. Not all pack sizes may be marketed.

Marketing authorization holder

Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain

Marketing authorization dates and numbers

EU/1/01/173/001-003

Date of first authorisation: 20 March 2001
Date of latest renewal: 07 March 2011

Drugs

Drug Countries
VANIQA Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.