Source: Health Products and Food Branch (CA) Revision Year: 2021
ANDROCUR.
Cyproterone acetate tablets 50 mg.
Cyproterone acetate injection 100 mg/mL.
Antiandrogen.
Table 1. Dosage forms, Strengths, Compositions and Packaging:
| Route of Administration | Dosage Form/ Strength/ Composition | Non-medicinal ingredients |
|---|---|---|
| Oral | Tablet, 50 mg | Colloidal anhydrous silica, lactose monohydrate, |
| Intramuscular | Intramuscular solution, 100 mg/mL | benzyl benzoate in a castor oil solution |
ANDROCUR (cyproterone acetate) 50 mg tablet is presented as white to faintly yellowish, round, flat-sided tablet with bevelled edges, imprinted on one side with “BV” in a regular hexagon, the other side is scored.
ANDROCUR DEPOT 3 mL (300 mg) ampoules.
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
Bayer Inc., 2920 Matheson Blvd East, Mississauga, Ontario, L4W 5R6 245903 |
Date of approval:
April 26, 1985 May 13, 2021 |
| 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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