PAT-DARUNAVIR TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Available from:

PATRIOT A DIVISION OF JANSSEN INC

ATC code:

J05AE10

INN (International Name):

DARUNAVIR

Dosage:

75MG

Pharmaceutical form:

TABLET

Composition:

DARUNAVIR (DARUNAVIR ETHANOLATE) 75MG

Administration route:

ORAL

Units in package:

480

Prescription type:

Prescription

Therapeutic area:

HIV PROTEASE INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2012-11-19

Summary of Product characteristics

_ _
_Page 1 of 78 _
PRODUCT
MONOGRAPH
PR
PAT-DARUNAVIR
darunavir tablets 75 mg, 150 mg, 400 mg, 600 mg, 800 mg
(as darunavir ethanolate)
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Patriot, a division of Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Date of Preparation:
November 30, 2012
www.patriot-canada.ca
Submission Control No: 159996
© JANSSEN Inc. 2012
All trademarks used under license.
Draft Date: Oct 26, 2012
_ _
_Page 2 of 78 _
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
...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
20
DOSAGE AND ADMINISTRATION
.....................................................................................
32
OVERDOSAGE
.......................................................................................................................
35
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 35
STORAGE AND STABILITY
.................................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 38
PART II: SCIENTIFIC INFORMATION
..............................................................................
40
PHARMACEUTICAL INFORMATION
.............................