NAT-DARUNAVIR TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

DARUNAVIR

Tilgjengelig fra:

NATCO PHARMA (CANADA) INC

ATC-kode:

J05AE10

INN (International Name):

DARUNAVIR

Dosering :

400MG

Legemiddelform:

TABLET

Sammensetning:

DARUNAVIR 400MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

HIV PROTEASE INHIBITORS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2020-10-21

Preparatomtale

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_NAT-DARUNAVIR _
_Page 1 of 83_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
NAT-DARUNAVIR
Darunavir tablets
400 mg, 600 mg and 800 mg, Oral
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, Suite 200
Mississauga, Ontario
L5N 1P7
Date of Initial Authorization:
OCT 20, 2020
Date of Revision:
MAY 03, 2023
Submission Control Number: 270484
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_NAT-DARUNAVIR _
_Page 2 of 83_
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
......................................................................