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CASODEX Film-coated tablets (2018)

Active ingredients: Bicalutamide

Product Name and Form

Casodex 150 mg film-coated tablets.

Pharmaceutical form

Film-coated tablet (tablet).

White.

Qualitative and Quantitative Composition

Each tablet contains 150 mg bicalutamide (INN).

For the full list of excipients, see section 6.1.

Chemical substance
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

Tablet Core:

Lactose monohydrate
Magnesium stearate
Povidone
Carboxymethyl amidon sodium

Film-coating material:

Hypromellose
Macrogol 300
Titanium dioxide

Pack sizes and Marketing

PVC/Aluminium foil blister pack comprising strips of 5, 10 and 14 tablets to give pack sizes of 10, 20, 30, 40, 50, 80, 90, 100, 200 or 14, 28, 56, 84, 140 and 280 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK

Date of first authorisation: 18th June 2000

Date of latest renewal: 16th June 2004

Marketing authorization number:

PL 17901/0006