BICALOX Film-coated tablet Ref.[50310] Active ingredients: Bicalutamide

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2018  Publisher: Douglas Pharmaceuticals Ltd, PO Box 45 027, Auckland 0651, New Zealand, Phone: (09) 835 0660

Product name and form

BICALOX film-coated tablet, 50 mg.

Pharmaceutical Form

BICALOX 50 mg is a white to off-white, round, film coated, biconvex tablets, engraved with ‘BC 50’ on one face and plain on the other.

Qualitative and quantitative composition

Each BICALOX tablet contains bicalutamide 50 mg.

Excipient(s) with known effect: BICALOX tablets contain lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Bicalutamide

Bicalutamide is a non-steroidal antiandrogen, devoid of other endocrine activity. It binds to androgen receptors without activating gene expression, and thus inhibits the androgen stimulus. Regression of prostatic tumours results from this inhibition.

List of Excipients

Lactose, sodium starch glycollate, povidone, magnesium stearate, opadry white Y-1-7000.

Pack sizes and marketing

PVC/PVdC-Aluminium blisters: 28, 30, 56, 98 tablets.

HDPE bottle: 100, 500 tablets.

Not all pack types or sizes may be marketed.

Marketing authorization holder

Douglas Pharmaceuticals Ltd, PO Box 45 027, Auckland 0651, New Zealand, Phone: (09) 835 0660

Marketing authorization dates and numbers

24 April 2008

Drugs

Drug Countries
BICALOX Australia, Hong Kong, New Zealand, Singapore, Tunisia, South Africa

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