AURO-DARUNAVIR TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE)

Tilgængelig fra:

AURO PHARMA INC

ATC-kode:

J05AE10

INN (International Name):

DARUNAVIR

Dosering:

800MG

Lægemiddelform:

TABLET

Sammensætning:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE) 800MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

HIV PROTEASE INHIBITORS

Produkt oversigt:

Active ingredient group (AIG) number: 0151656006; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2020-01-02

Produktets egenskaber

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