CYPROSTAT Tablet Ref.[27754] Active ingredients: Cyproterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Product name and form

Cyprostat 50 mg.

Pharmaceutical Form

Tablet.

White, round tablet, scored on one side and embossed with the letters “BV” in a regular hexagon on the other side.

Qualitative and quantitative composition

Each white, scored tablet contains 50 mg cyproterone acetate.

Excipient with known effect: lactose 108.75 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cyproterone

Cyproterone acetate acts as an antiandrogen by blocking androgen receptors. It also has progestogenic activity, which exerts a negative feedback effect on hypothalamic receptors, so leading to a reduction in gonadotrophin release, and hence to diminished production of testicular androgens. Sexual drive and potency are reduced and gonadal function is inhibited.

List of Excipients

Maize starch
Povidone 25 000
Magnesium stearate (E572)
Lactose
Colloidal anhydrous silica

Pack sizes and marketing

Original packs containing 160 tablets (16 blister strips of 10 tablets), 80 tablets (8 blister strips of 10 tablets) or 60 tablets (6 blister strips of 10 tablets).

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Marketing authorization dates and numbers

PL 00010/0525

Date of first authorisation: 01 May 2008
Date of Renewal of the Authorisation: 08 August 2003

Drugs

Drug Countries
CYPROSTAT Australia, Malta, United Kingdom

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