NAT-DARUNAVIR TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DARUNAVIR

Disponible depuis:

NATCO PHARMA (CANADA) INC

Code ATC:

J05AE10

DCI (Dénomination commune internationale):

DARUNAVIR

Dosage:

400MG

forme pharmaceutique:

TABLET

Composition:

DARUNAVIR 400MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HIV PROTEASE INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2020-10-21

Résumé des caractéristiques du produit

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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
......................................................................