ANDROCUR Tablet Ref.[7210] 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

Androcur 50 mg tablets.

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 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

Lactose
Maize starch
Povidone 25 000
Silicon dioxide (aerosil) (E551)
Magnesium stearate (E572)

Pack sizes and marketing

PVC/Aluminium blister pack.

Pack size: 60 tablets.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL00010/0519

Date of first authorisation: 01 May 2008

Drugs

Drug Countries
ANDROCUR Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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