PREZISTA TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Disponible des:

JANSSEN INC

Codi ATC:

J05AE10

Designació comuna internacional (DCI):

DARUNAVIR

Dosis:

75MG

formulario farmacéutico:

TABLET

Composición:

DARUNAVIR (DARUNAVIR ETHANOLATE) 75MG

Vía de administración:

ORAL

Unidades en paquete:

480

tipo de receta:

Prescription

Área terapéutica:

HIV PROTEASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0151656004; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2009-12-02

Fitxa tècnica

_Non Ann PM PRZ SNDS 268362 02232023.docx _
_EDMS-RIM-841119 v8.0 _
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_Page 1 of 93_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PREZISTA
®
darunavir tablets 75 mg, 150 mg, 600 mg, 800 mg
darunavir oral suspension 100 mg/mL
(as darunavir ethanolate)
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Initial Authorization:
July 27, 2006
Date of Revision:
March 3, 2023
Submission Control Number: 268362
© 2023 Janssen Inc.
All trademarks used under license
_Non Ann PM PRZ SNDS 268362 02232023.docx _
_EDMS-RIM-841119 v8.0 _
_ _
_Page 2 of 93_
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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
........