MYLAN-ATAZANAVIR CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

ATAZANAVIR (ATAZANAVIR SULFATE)

から入手可能:

MYLAN PHARMACEUTICALS ULC

ATCコード:

J05AE08

INN（国際名）:

ATAZANAVIR

投薬量:

200MG

医薬品形態:

CAPSULE

構図:

ATAZANAVIR (ATAZANAVIR SULFATE) 200MG

投与経路:

ORAL

パッケージ内のユニット:

60

処方タイプ:

Prescription

治療領域:

HIV PROTEASE INHIBITORS

製品概要:

Active ingredient group (AIG) number: 0149741003; AHFS:

認証ステータス:

APPROVED

承認日:

2017-04-18

製品の特徴

_ _
_Page 1 of 81_
PRODUCT MONOGRAPH
Pr
MYLAN-ATAZANAVIR
atazanavir sulfate capsules
150 mg, 200 mg and 300 mg atazanavir
Azapeptide Inhibitor of HIV-1 Protease
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
May 19, 2021
Submission
Control No: 251525
_ _
_Page 2 of 81 _
_ _
_ _
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
............................................................................................24
DOSAGE AND ADMINISTRATION
.........................................................................40
OVERDOSAGE
.........................................................................................................42
ACTION AND CLINICAL
PHARMACOLOGY.........................................................43
STORAGE AND STABILITY
....................................................................................48
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................48
PART II: SCIENTIFIC INFORMATION
..........................................................................
50
PHARMACEUTICAL INFORMATION
.....................................................................50
CLINICAL TRIALS
...................................................................................................52
DETAILED
PHARMACOLOGY................................................................................58
MICROBIOLOGY
..........................