DARUNAVIR TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

DARUNAVIR

Disponible desde:

JAMP PHARMA CORPORATION

Código ATC:

J05AE10

Designación común internacional (DCI):

DARUNAVIR

Dosis:

400MG

formulario farmacéutico:

TABLET

Composición:

DARUNAVIR 400MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

HIV PROTEASE INHIBITORS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2021-10-18

Ficha técnica

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_ Darunavir _ _Page 1 of 95 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DARUNAVIR
Darunavir tablets
Tablets, 400 mg, 600 mg and 800 mg,
Oral
Manufacturer's Standard
Human Immunodeficiency Virus (HIV) Protease Inhibitor
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control Number: 274675
Date
of
Initial
Authorization:
OCT 18, 2021
Date of Revision:
MAY 10,
2023
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_ Darunavir _ _Page 2 of 95 _
RECENT MAJOR LABEL CHANGES
NOT APPLICABLE
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.................................................................................................................