PREZISTA TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Available from:

JANSSEN INC

ATC code:

J05AE10

INN (International Name):

DARUNAVIR

Dosage:

400MG

Pharmaceutical form:

TABLET

Composition:

DARUNAVIR (DARUNAVIR ETHANOLATE) 400MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

HIV PROTEASE INHIBITORS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-09-01

Summary of Product characteristics

_Approved Product Monograph 1.doc _
_Page 1 of 90 _
PRODUCT
MONOGRAPH
PR
PREZISTA
®
darunavir tablets 75 mg, 150 mg, 400 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 Preparation:
July 27, 2006
Date of Revision:
August 15, 2016
Submission Control No: 188263
© 2016 Janssen Inc.
All trademarks used under license.
_Approved Product Monograph 1.doc _
_Page 2 of 90 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
22
DOSAGE AND ADMINISTRATION
.....................................................................................
38
OVERDOSAGE
.......................................................................................................................
41
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 42
STORAGE AND STABILITY
.................................................................................................
45
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 46
PART II: SCIENTIFIC INFORMATION
..........................................................