CYPROTERONE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CYPROTERONE ACETATE

Available from:

AA PHARMA INC

ATC code:

G03HA01

INN (International Name):

CYPROTERONE

Dosage:

50MG

Pharmaceutical form:

TABLET

Composition:

CYPROTERONE ACETATE 50MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0116806001; AHFS:

Authorization status:

APPROVED

Authorization date:

2002-09-04

Summary of Product characteristics

_CYPROTERONE (Cyproterone Acetate) _
_ _
_Page 1 of 38 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CYPROTERONE
Cyproterone Acetate Tablets
Tablets, 50 mg, Oral
House Standard
Antiandrogen
AA PHARMA INC.
1165 Creditstone Road Unit# 1
Vaughan, Ontario
L4K 4N7
www.aapharma.ca
Date of Initial Authorization:
SEP 04, 2002
Date of Revision:
JAN 20, 2023
Submission Control Number: 269132
_CYPROTERONE (Cyproterone Acetate) _
_ _
_Page 2 of 38 _
RECENT MAJOR LABEL CHANGES
Not Applicable
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES ..................................................................................................
2
TABLE OF CONTENTS .....................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................................
4
1
INDICATIONS ........................................................................................................................
4
2
CONTRAINDICATIONS ..........................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................................. 4
4
DOSAGE AND ADMINISTRATION ........................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
5
OVERDOSAGE .......................................................................................................................
5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..................................... 6
7
WARNINGS AND PRECAUTIONS ...............................................................................