ANDROCUR TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-05-2021
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Active ingredient:
CYPROTERONE ACETATE
Available from:
BAYER INC
ATC code:
G03HA01
INN (International Name):
CYPROTERONE
Dosage:
50MG
Pharmaceutical form:
TABLET
Composition:
CYPROTERONE ACETATE 50MG
Administration route:
ORAL
Units in package:
60
Prescription type:
Prescription
Therapeutic area:
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0116806001; AHFS:
Authorization status:
APPROVED
Authorization date:
2007-03-21
Summary of Product characteristics
_ANDROCUR Product Monograph_
Page 1 of 32
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ANDROCUR
®
cyproterone acetate tablets
50 mg
PR
ANDROCUR
® DEPOT
Cyproterone acetate injection
100 mg/mL
Antiandrogen
Bayer Inc.
2920 Matheson Blvd East,
Mississauga, Ontario
L4W 5R6
www.bayer.ca
Date of Initial Approval:
April 26, 1985
Date of Revision:
May 13, 2021
Submission Control No: 245903
©
2021, Bayer Inc.
® TM see www.bayer.ca/tm-mc.
_ANDROCUR Product Monograph_
Page 2 of 32
Sections or subsections that are not applicable at the time of
authorization are not listed.
TABLE OF CONTENTS ...................................................................................................................2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................................................................
3
1.
INDICATIONS
................................................................................................................................................................
3
2.
CONTRAINDICATIONS
.................................................................................................................................................
3
3.
SERIOUS
WARNINGS
AND
PRECAUTIONS
.................................................................................................................
3
4.
DOSAGE
AND
ADMINISTRATION................................................................................................................................
3
4.1 Dosing Considerations
..........................................................................................................................................
3
4.2 Recommended Dose and Dosage
Adjustment....................................................................................................
3
4.3 Reconstitution
.......................................................................................................................................................
4
4.4 Administration
.........
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