AURO-DARUNAVIR TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE)

Dostępny od:

AURO PHARMA INC

Kod ATC:

J05AE10

INN (International Nazwa):

DARUNAVIR

Dawkowanie:

400MG

Forma farmaceutyczna:

TABLET

Skład:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE) 400MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

HIV PROTEASE INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0151656002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2020-01-02

Charakterystyka produktu

_Auro-Darunavir Product Monograph _Page 1 of 88
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-DARUNAVIR
Darunavir Tablets
Tablets, 400 mg, 600 mg and 800 mg darunavir (as darunavir propylene
glycolate), Oral
Human Immunodeficiency Virus (HIV) Protease Inhibitor
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Initial Authorization:
January 2, 2020
Date of Revision:
January 4, 2023
Submission Control Number: 270155
_Auro-Darunavir Product Monograph _Page 2 of 88
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.........................................................................................
2
TABLE OF CONTENTS
...........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 4
1 INDICATIONS
....................................................................................................................
4
1.1 Pediatrics
....................................................................................................................
4
1.2 Geriatrics
....................................................................................................................
4
2 CONTRAINDICATIONS
.......................................................................................................
4
4 DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1 Dosing Considerations
................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
........................................................... 5
4.5 Missed Dose
................................................................................................................
8
5 OVE