Country: Canada
Language: English
Source: Health Canada
ATAZANAVIR (ATAZANAVIR SULFATE)
TEVA CANADA LIMITED
J05AE08
ATAZANAVIR
300MG
CAPSULE
ATAZANAVIR (ATAZANAVIR SULFATE) 300MG
ORAL
10/30/60
Prescription
HIV PROTEASE INHIBITORS
Active ingredient group (AIG) number: 0149741004; AHFS:
APPROVED
2017-04-18
_ _ _Teva-Atazanavir _ _Page 1 of 73_ PRODUCT MONOGRAPH PR TEVA-ATAZANAVIR Atazanavir capsules 150 mg, 200 mg and 300 mg (as atazanavir sulfate) Azapeptide Inhibitor of HIV-1 Protease Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 www.tevacanada.com Date of Revision: April 12, 2021 Submission Control No: 240892 _ _ _Teva-Atazanavir _ _Page 2 of 73_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................................... 3 SUMMARY PRODUCT INFORMATION ........................................................................ 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS ................................................................................. 5 ADVERSE REACTIONS ................................................................................................. 12 DRUG INTERACTIONS ................................................................................................. 23 DOSAGE AND ADMINISTRATION ............................................................................. 35 OVERDOSAGE ................................................................................................................ 38 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 39 STORAGE AND STABILITY ......................................................................................... 43 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 44 PART II: SCIENTIFIC INFORMATION .................................................................................... 45 PHARMACEUTICAL INFORMATION ......................................................................... 45 CLINICAL TRIALS ...................................................................................................... Read the complete document