AURO-DARUNAVIR TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE)

Fáanlegur frá:

AURO PHARMA INC

ATC númer:

J05AE10

INN (Alþjóðlegt nafn):

DARUNAVIR

Skammtar:

600MG

Lyfjaform:

TABLET

Samsetning:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE) 600MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

HIV PROTEASE INHIBITORS

Vörulýsing:

Active ingredient group (AIG) number: 0151656003; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2020-01-02

Vara einkenni

Auro-Darunavir Product Monograph
Page 1 of 96
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-DARUNAVIR
Darunavir Tablets
Tablets, 400 mg, 600 mg, 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:
December 7, 2023
Submission Control Number: 276175
Auro-Darunavir Product Monograph
Page 2 of 96
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization
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
............................................