GYNOXIN Vaginal capsule, soft Ref.[49938] Active ingredients: Fenticonazole

Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Recordati Industria Chimica e Farmaceutica SpA, Via Matteo Civitali, 20148, Milan, Italy

Product name and form

Gynoxin 200 mg Vaginal Capsules.

Pharmaceutical Form
Vaginal capsule, soft. (Vaginal capsule) Ivory white, opaque, soft gelatin capsules.

Qualitative and quantitative composition

Each vaginal capsule contains 200 mg of the active ingredient fenticonazole nitrate.

Excipients with known effect: also includes ethyl parahydroxybenzoate sodium (E215) 800 micrograms per vaginal capsule, and sodium propyl parahydroxybenzoate (E217) 400 micrograms per vaginal capsule.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Fenticonazole	Fenticonazole is a broad-spectrum antimycotic agent.

List of Excipients
Medium chain triglycerides Colloidal anhydrous silica Shell constituents: Gelatin Glycerol Titanium dioxide Ethyl Parahydroxybenzoate Sodium (E215) Sodium Propyl Parahydroxybenzoate (E217)

Pack sizes and marketing

Blister pack of PVC/PVdC + aluminium foil, in packs of 3.

Marketing authorization holder

Recordati Industria Chimica e Farmaceutica SpA, Via Matteo Civitali, 20148, Milan, Italy

Marketing authorization dates and numbers

PA0812/004/001

Date of first authorisation: 24^th February 1992
Date of last renewal: 23^rd February 2007

Drugs

Drug	Countries
GYNOXIN	Ireland, Poland

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