MAVIRET TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

PIBRENTASVIR; GLECAPREVIR

Disponible desde:

ABBVIE CORPORATION

Código ATC:

J05AP57

Designación común internacional (DCI):

GLECAPREVIR AND PIBRENTASVIR

Dosis:

40MG; 100MG

formulario farmacéutico:

TABLET

Composición:

PIBRENTASVIR 40MG; GLECAPREVIR 100MG

Vía de administración:

ORAL

Unidades en paquete:

21/84

tipo de receta:

Prescription

Área terapéutica:

HCV Protease Inhibitors

Resumen del producto:

Active ingredient group (AIG) number: 0259390001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2017-08-16

Ficha técnica

_ _
_MAVIRET (glecaprevir/pibrentasvir) _
_ Date of Revision: APR 7, 2022 _
_Submission Control No. 252251 _
_Page 1 of 82_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MAVIRET®
glecaprevir/pibrentasvir tablets and granules
Tablets, glecaprevir 100 mg / pibrentasvir 40 mg, oral
Granules, glecaprevir 50 mg / pibrentasvir 20 mg per sachet, oral
Antiviral Agent (ATC Code: J05AP57)
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Qc H4S 1Z1
Date of Initial Authorization:
AUG 16, 2017
Date of Revision:
APR 7, 2022
Submission Control Number: 252251
_ _
_MAVIRET (glecaprevir/pibrentasvir) _
_ Date of Revision: APR 7, 2022 _
_Submission Control No. 252251 _
_Page 2 of 82_
RECENT MAJOR LABEL CHANGES
Indication (1)
11/2021
Indication (1), Pediatrics (1.1)
11/2021
Dosage and Administration (4), Recommended Dose and Dosage
Adjustment (4.2)
11/2021
Warnings and Precautions (7), Special Populations (7.1), Pediatrics
(7.1.3)
11/2021
Warnings and Precautions (7), Monitoring and Laboratory Tests
06/2020
Warnings and Precautions (7), Hepatic Decompensation and
Hepatic Failure
03/2021
TABLE OF CONTENTS
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................