TEVA-ATAZANAVIR CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ATAZANAVIR (ATAZANAVIR SULFATE)

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

J05AE08

INN (International Adı):

ATAZANAVIR

Doz:

300MG

Farmasötik formu:

CAPSULE

Kompozisyon:

ATAZANAVIR (ATAZANAVIR SULFATE) 300MG

Uygulama yolu:

ORAL

Paketteki üniteler:

10/30/60

Reçete türü:

Prescription

Terapötik alanı:

HIV PROTEASE INHIBITORS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2017-04-18

Ürün özellikleri

_ _
_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
......................................................................................................