MAVIRET GRANULES

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

GLECAPREVIR; PIBRENTASVIR

Dostupné z:

ABBVIE CORPORATION

ATC kód:

J05AP57

INN (Medzinárodný Name):

GLECAPREVIR AND PIBRENTASVIR

Dávkovanie:

50MG; 20MG

Forma lieku:

GRANULES

Zloženie:

GLECAPREVIR 50MG; PIBRENTASVIR 20MG

Spôsob podávania:

ORAL

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

HCV Protease Inhibitors

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2021-11-29

Súhrn charakteristických

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