AURO-DARUNAVIR TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE)

Commercializzato da:

AURO PHARMA INC

Codice ATC:

J05AE10

INN (Nome Internazionale):

DARUNAVIR

Dosaggio:

400MG

Forma farmaceutica:

TABLET

Composizione:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE) 400MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

HIV PROTEASE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2020-01-02

Scheda tecnica

_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
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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