MYLAN-DARUNAVIR TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

DARUNAVIR

Dostupné z:

MYLAN PHARMACEUTICALS ULC

ATC kód:

J05AE10

INN (Medzinárodný Name):

DARUNAVIR

Dávkovanie:

150MG

Forma lieku:

TABLET

Zloženie:

DARUNAVIR 150MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

HIV PROTEASE INHIBITORS

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2022-01-27

Súhrn charakteristických

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
..........................................................