JAMP ATAZANAVIR CAPSULE

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ATAZANAVIR (ATAZANAVIR SULFATE)

Disponible desde:

JAMP PHARMA CORPORATION

Código ATC:

J05AE08

Designación común internacional (DCI):

ATAZANAVIR

Dosis:

300MG

formulario farmacéutico:

CAPSULE

Composición:

ATAZANAVIR (ATAZANAVIR SULFATE) 300MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

HIV PROTEASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0149741004; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2021-03-04

Ficha técnica

Page 1 of 77
PRODUCT MONOGRAPH
PR
JAMP ATAZANAVIR
Atazanavir capsules
150, 200 and 300 mg
(as atazanavir sulfate)
House Standard
Azapeptide Inhibitor of HIV-1 Protease
JAMP Pharma Corporation
Date of Preparation:
1310, rue Nobel
February 26, 2021
Boucherville, Québec
J4B 5H3
CONTROL NUMBER: 231176
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
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
...............................................................................37
OVERDOSAGE
.................................................................................................................39
ACTION AND CLINICAL PHARMACOLOGY
.............................................................40
STORAGE AND STABILITY
..........................................................................................45
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................45
PART II : SCIENTIFIC INFORMATION
................................................................................46
PHARMACEUTICAL INFORMATION
..........................................................................46
CLINICAL TRIALS
..........................................................................................................46
DETAILED
PHARMACOLOGY.....................................