REYATAZ CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ATAZANAVIR (ATAZANAVIR SULFATE)

Available from:

BRISTOL-MYERS SQUIBB CANADA

ATC code:

J05AE08

INN (International Name):

ATAZANAVIR

Dosage:

150MG

Pharmaceutical form:

CAPSULE

Composition:

ATAZANAVIR (ATAZANAVIR SULFATE) 150MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

HIV PROTEASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0149741002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-04-28

Summary of Product characteristics

_ _
_ _
_Page 1 of 77_
PRODUCT MONOGRAPH
PR REYATAZ
®
Atazanavir capsules
150, 200 and 300 mg
(as atazanavir sulfate)
Azapeptide Inhibitor of HIV-1 Protease
Bristol-Myers Squibb Canada Co.
Date of Preparation:
Montreal, Canada
December 3, 2003
Date of Revision:
April 28, 2020
®
Registered trademark of Bristol-Myers Squibb Holdings Ireland used
under licence by Bristol-Myers Squibb
Canada Co.
CONTROL NUMBER: 236039
_ _
_ _
_Page 2 of 77_
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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................39
OVERDOSAGE
.................................................................................................................41
ACTION AND CLINICAL PHARMACOLOGY
............................................................42
STORAGE AND STABILITY
..........................................................................................46
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................47
PART II : SCIENTIFIC INFORMATION
...............................................................................48
PHARMACEUTICAL INFORMATION
..........................................................................48
CLINICAL TRIALS
...........................................