GYNO-PEVARYL Vaginal cream Ref.[8023] Active ingredients: Econazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Product name and form

Gyno-Pevaryl Cream.

Pharmaceutical Form

Vaginal cream.

Qualitative and quantitative composition

Each 100 g of cream contains 1 g econazole nitrate (1% w/w).

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

Tefose 63
Labrafil M 1944 CS
Mineral oil
Butylated hydroxyanisole (E320)
Benzoic acid (E210)
Purified water

Pack sizes and marketing

Aluminium lacquered tubes.

Pack sizes 78 g, 30g, 15g.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00242/0229

22 September 1995 / June 2003

Drugs

Drug Countries
GYNO-PEVARYL Austria, Estonia, France, Ireland, Israel, Lithuania, Poland, Singapore, United Kingdom, South Africa

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