ZIDOVAL Vaginal gel Ref.[50031] Active ingredients: Methronidazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Zidoval 7.5 mg/g vaginal gel.

Pharmaceutical Form

Vaginal gel.

A colourless to straw coloured gel.

Qualitative and quantitative composition

Metronidazole 0.75% w/w, 7.5 mg/g.

Excipients with known effect:

Methyl parahydroxybenzoate (E218) 0.8 mg/g.
Propyl parahydroxybenzoate (E216) 0,2 mg/g.
Propylene glycol (E1520) 30.0 mg/g.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Methronidazole

Metronidazole is an anti-infectious drug belonging to the pharmacotherapeutic group of nitroimidazole derivatives, which have effect mainly on strict anaerobes. This effect is probably caused by interaction with DNS and different metabolites.

List of Excipients

Carbomer (Carbopol) 974P
Disodium edetate
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Propylene glycol
Sodium hydroxide
Purified water

Pack sizes and marketing

Aluminium tubes lined with an epoxy phenolic resin with polyethylene screw caps containing 40 g product. The product is packaged with 5 disposable vaginal applicators, each to deliver 5 g of gel.

Marketing authorization holder

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0153

31 January 1997 / 15 February 2010

Drugs

Drug Countries
ZIDOVAL Finland, Israel, Malta, United Kingdom

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