PROVERA Tablet Ref.[7813] Active ingredients: Medroxyprogesterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, CT13 9NJ, UK

Product name and form

Provera 10 mg Tablets.

Pharmaceutical Form

Tablets.

Qualitative and quantitative composition

Each tablet contains 10 mg medroxyprogesterone acetate.

Excipients with known effect: Lactose monohydrate 110 mg, sucrose 2 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Medroxyprogesterone

Medroxyprogesterone acetate exerts anti-oestrogenic, anti-androgenic and antigonadotrophic effects.

List of Excipients

Lactose
Sucrose
Maize starch
Liquid Paraffin
Talc
Calcium Stearate
Purified Water

Pack sizes and marketing

HDPE tamper-evident bottles with LDPE push-fit tamper evident caps, containing 50 tablets.

Aluminium foil/PVC blisters, containing 10, 20, 30, 50, 90 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00057/1033

Date of first authorisation: 21 September 2010

Drugs

Drug Countries
PROVERA Australia, Brazil, Canada, Ecuador, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Japan, Malta, Mexico, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States, South Africa

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