MYLAN-DARUNAVIR TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

DARUNAVIR

Предлага се от:

MYLAN PHARMACEUTICALS ULC

АТС код:

J05AE10

INN (Международно Name):

DARUNAVIR

дозиране:

150MG

Лекарствена форма:

TABLET

Композиция:

DARUNAVIR 150MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

HIV PROTEASE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0151656005; AHFS:

Статус Оторизация:

CANCELLED PRE MARKET

Дата Оторизация:

2022-01-27

Данни за 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
..........................................................