MAR-DARUNAVIR TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DARUNAVIR

Available from:

MARCAN PHARMACEUTICALS INC

ATC code:

J05AE10

INN (International Name):

DARUNAVIR

Dosage:

400MG

Pharmaceutical form:

TABLET

Composition:

DARUNAVIR 400MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

HIV PROTEASE INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2020-09-01

Summary of Product characteristics

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_MAR-DARUNAVIR _ _Page 1 of 105 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-DARUNAVIR
Darunavir tablets
Tablets, 400 mg, 600 mg and 800 mg,
Oral
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Marcan Pharmaceuticals Inc.
2 Gurdwara Rd, Suite #112
Ottawa, Ontario K2E 1A2
Date of Initial Authorization:
September 1, 2020
Date of Revision:
January 5, 2023
Submission Control Number: 270480
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_MAR-DARUNAVIR _ _Page 2 of 105 _
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
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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
..........................