AURO-DARUNAVIR TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE)

Disponible depuis:

AURO PHARMA INC

Code ATC:

J05AE10

DCI (Dénomination commune internationale):

DARUNAVIR

Dosage:

600MG

forme pharmaceutique:

TABLET

Composition:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE) 600MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HIV PROTEASE INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2020-01-02

Résumé des caractéristiques du produit

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