MAVIRET GRANULES

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

GLECAPREVIR; PIBRENTASVIR

Disponible depuis:

ABBVIE CORPORATION

Code ATC:

J05AP57

DCI (Dénomination commune internationale):

GLECAPREVIR AND PIBRENTASVIR

Dosage:

50MG; 20MG

forme pharmaceutique:

GRANULES

Composition:

GLECAPREVIR 50MG; PIBRENTASVIR 20MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HCV Protease Inhibitors

Descriptif du produit:

For pediatric use.; Active ingredient group (AIG) number: 0259390002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2021-11-29

Résumé des caractéristiques du produit

_ _
_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
.......................