MYLAN-DARUNAVIR TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

DARUNAVIR

Доступна с:

MYLAN PHARMACEUTICALS ULC

код АТС:

J05AE10

ИНН (Международная Имя):

DARUNAVIR

дозировка:

75MG

Фармацевтическая форма:

TABLET

состав:

DARUNAVIR 75MG

Администрация маршрут:

ORAL

Штук в упаковке:

100

Тип рецепта:

Prescription

Терапевтические области:

HIV PROTEASE INHIBITORS

Обзор продуктов:

Active ingredient group (AIG) number: 0151656004; AHFS:

Статус Авторизация:

CANCELLED PRE MARKET

Дата Авторизация:

2022-01-27

Характеристики продукта

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MYLAN-DARUNAVIR
Darunavir Tablets
75 mg, 150 mg, 300 mg, 400 mg, 600 mg and 800 mg
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Preparation:
June 21, 2019
Date of Revision:
Jan 2, 2020
Submission Control No: 163712, 187980, 205319, 213903, 218251, 228649
2 | 90
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...................................................................
3
SUMMARY PRODUCT INFORMATION
.................................................................................
3
CONTRAINDICATIONS
............................................................................................................
4
WARNINGS AND
PRECAUTIONS...........................................................................................
5
ADVERSE REACTIONS
..........................................................................................................
10
DRUG INTERACTIONS
...........................................................................................................
21
DOSAGE AND ADMINISTRATION
...........................................................................................
OVERDOSAGE
.............................................................................................................................
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
STORAGE AND
STABILITY.......................................................................................................
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................................
PART II: SCIENTIFIC INFORMATION
.............................................................................................
PHARMACEUTICAL INFORMATION
......................................................................................
CLINICAL TRIALS
..........................................................