ATRIPLA TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Предлага се от:

GILEAD SCIENCES, LLC

АТС код:

J05AR06

INN (Международно Name):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

дозиране:

600MG; 200MG; 300MG

Лекарствена форма:

TABLET

Композиция:

EFAVIRENZ 600MG; EMTRICITABINE 200MG; TENOFOVIR DISOPROXIL FUMARATE 300MG

Начин на приложение:

ORAL

Броя в опаковка:

30

Вид предписание :

Prescription

Терапевтична област:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0352327001; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2021-12-22

Данни за продукта

PRODUCT MONOGRAPH
PR
ATRIPLA
®
(EFAVIRENZ/EMTRICITABINE/
TENOFOVIR DISOPROXIL FUMARATE) TABLETS
600 MG EFAVIRENZ
200 MG EMTRICITABINE
300 MG TENOFOVIR DISOPROXIL FUMARATE
ANTIRETROVIRAL AGENT
Gilead Sciences, LLC.
Foster City, CA 94404
USA
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
www.gilead.ca
Submission Control No.: 235076_ _
Date of Revision:
February 12, 2020
ATRIPLA
®
(efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets
Product Monograph
Page 2
TABLE OF CONTENTS
PART I.
HEALTH PROFESSIONAL INFORMATION
................................................................................
3
SUMMARY PRODUCT INFORMATION
..................................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................................
3
CONTRAINDICATIONS
.............................................................................................................................
3
WARNINGS AND PRECAUTIONS
............................................................................................................
5
ADVERSE REACTIONS
............................................................................................................................
15
DRUG INTERACTIONS
............................................................................................................................
25
DOSAGE AND ADMINISTRATION
........................................................................................................
44
OVERDOSAGE
..........................................................................................................................................
45
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................................
46
STORAGE AND STABILITY
....................................................................................................................
50
SPECIAL HANDLING
INSTRUCTIONS........