PROSTIN E2 Vaginal tablet Ref.[9746] Active ingredients: Dinoprostone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Product name and form

Prostin E2 Vaginal Tablets 3mg.

Pharmaceutical Form

Vaginal tablet.

White, biconvex, oblong tablet, embossed with Upjohn 715 on one side and plain on the other.

Qualitative and quantitative composition

Each tablet contains 3 mg dinoprostone.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dinoprostone
List of Excipients

Lactose
Microcrystalline cellulose
Colloidal silicon dioxide
Maize starch
Magnesium stearate

Pack sizes and marketing

Amber glass bottle with screw cap and tac seal. Each bottle contains a desiccant capsule and 4 tablets.

Aluminium foil strip of 4 tablets, each box containing 4 or 8 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Marketing authorization dates and numbers

PL 00057/1516

Date of first authorisation: 15 March 1982
Date of last renewal: 28 October 2004

Drugs

Drug Countries
PROSTIN E2 Austria, Canada, Cyprus, Hong Kong, Ireland, Israel, Malta, Netherlands, New Zealand, Singapore, United Kingdom, United States

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