PEVARYL Topical cream Ref.[8009] Active ingredients: Econazole

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

Product name and form

Pevaryl 1% Topical Cream.

Pharmaceutical Form

Cream.

Qualitative and quantitative composition

Econazole nitrate – 1.0% w/w.

Each gram of cream contains 10 mg econazole nitrate.

Excipients: each gram of cream contains 2 mg benzoic acid and 52 micrograms butylhydroxyanisole

For a full list of excipients, see section 6.1.

Active Ingredient Description
Econazole

Econazole nitrate is a broad spectrum antimycotic with activity against dermatophytes, yeasts and moulds. A clinically relevant action against Gram positive bacteria has also been found.

List of Excipients

Macrogols (PEG-6 and PEG-32) / glycol stearate
Oleoyl macrogolglycerides
Liquid paraffin
Butylhydroxyanisole (E320)
Benzoic acid (E210)
Flower Perfume 4074
Purified water

Pack sizes and marketing

Resin lined, aluminium tubes containing 15 g or 30 g of cream.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00242/0259

Date of first authorisation: 01 March 1995

Renewal of authorisation: 18 March 2009

Drugs

Drug Countries
PEVARYL Austria, France, New Zealand, Poland, United Kingdom, South Africa

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