MAR-DARUNAVIR TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DARUNAVIR

Διαθέσιμο από:

MARCAN PHARMACEUTICALS INC

Φαρμακολογική κατηγορία (ATC):

J05AE10

INN (Διεθνής Όνομα):

DARUNAVIR

Δοσολογία:

400MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

DARUNAVIR 400MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HIV PROTEASE INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2020-09-01

Αρχείο Π.Χ.Π.

_ _
___________________________________________________________________________________________________
_ _
_ _
_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
_ _
___________________________________________________________________________________________________
_ _
_ _
_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
............................................................................................
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
..........................