RIVA-CYPROTERONE TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

CYPROTERONE ACETATE

متاح من:

LABORATOIRE RIVA INC.

ATC رمز:

G03HA01

INN (الاسم الدولي):

CYPROTERONE

جرعة:

50MG

الشكل الصيدلاني:

TABLET

تركيب:

CYPROTERONE ACETATE 50MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

60

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2012-11-01

خصائص المنتج

RIVA-CYPROTERONE - Product Monograph
Page 1 of 32
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
RIVA-CYPROTERONE
Cyproterone Acetate Tablets
Tablets, 50
m
g, Oral
Antiandrogen
Laboratoire Riva Inc.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Date of Initial Authorization:
November 1, 2012
Date of Revision:
April 7, 2022
Submission Control No.: 262595
RIVA-CYPROTERONE - Product Monograph
Page 2 of 32
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
04/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
04/2022
7 WARNINGS AND PRECAUTIONS - Carcinogenesis and Mutagenesis
04/2022
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
................................................................................4
4
DOSAGE AND ADMINISTRATION
............................................................................................4
4.1
Dosing Considerations
...........................................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment
......................................................................
5
5
OVERDOSAGE
........................................................................................................................5
6
D