PREZISTA TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Inapatikana kutoka:

JANSSEN INC

ATC kanuni:

J05AE10

INN (Jina la Kimataifa):

DARUNAVIR

Kipimo:

150MG

Dawa fomu:

TABLET

Tungo:

DARUNAVIR (DARUNAVIR ETHANOLATE) 150MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

240

Dawa ya aina:

Prescription

Eneo la matibabu:

HIV PROTEASE INHIBITORS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0151656005; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2011-07-07

Tabia za bidhaa

_Non Ann PM PRZ SNDS 268362 02232023.docx _
_EDMS-RIM-841119 v8.0 _
_ _
_Page 1 of 93_
_ _
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_
_ _
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
........