CERVAGEM Vaginal pessary Ref.[11079] Active ingredients: Gemeprost

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Cervagem 1mg Pessary.

Pharmaceutical Form

White to yellowish-white spindle shaped vaginal pessary.

Qualitative and quantitative composition

Each pessary contains gemeprost 1.0mg.

Active Ingredient Description
Gemeprost

Gemeprost (16, 16-dimethyl-trans-delta2 PGE1 methyl ester) is a prostaglandin E1 analogue. Both in pregnant and non-pregnant animals, it causes contraction of the uterus and causes softening and decreases resistance of cervical tissue. Gemeprost depresses placental and uterine blood flow but those actions are secondary to the main uterine stimulation.

List of Excipients

Witepsol S 52
Dehydrated ethanol

Pack sizes and marketing

Container of 5 or 10 unit dose foil pessaries.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0373

16 September 2005

Drugs

Drug Countries
CERVAGEM Singapore, United Kingdom

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