MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Доступна з:

MYLAN PHARMACEUTICALS ULC

Код атс:

J05AR06

ІПН (Міжнародна Ім'я):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

Дозування:

600MG; 200MG; 300MG

Фармацевтична форма:

TABLET

Склад:

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

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

30

Тип рецепту:

Prescription

Терапевтична области:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2017-07-26

Характеристики продукта

PAGE 1 OF 75
PRODUCT MONOGRAPH
PR MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLETS
600 MG EFAVIRENZ
200 MG EMTRICITABINE
300 MG TENOFOVIR DISOPROXIL FUMARATE
MYLAN STD.
ANTIRETROVIRAL AGENT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision: July 27, 2020
Submission Control No: 241548
PAGE 2 OF 75
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
.......................................................................................................................................
24
DOSAGE
AND
ADMINISTRATION....................................................................................................................
40
OVERDOSAGE
.....................................................................................................................................................
41
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................
42
STORAGE
AND
STABILITY
.......................................................................................................................