Maa: Kanada
Kieli: englanti
Lähde: Health Canada
CYPROTERONE ACETATE
LABORATOIRE RIVA INC.
G03HA01
CYPROTERONE
50MG
TABLET
CYPROTERONE ACETATE 50MG
ORAL
60
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0116806001; AHFS:
APPROVED
2012-11-01
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 Lue koko asiakirja