Land: Kanada
Språk: engelska
Källa: Health Canada
GLECAPREVIR; PIBRENTASVIR
ABBVIE CORPORATION
J05AP57
GLECAPREVIR AND PIBRENTASVIR
50MG; 20MG
GRANULES
GLECAPREVIR 50MG; PIBRENTASVIR 20MG
ORAL
15G/50G
Prescription
HCV Protease Inhibitors
For pediatric use.; Active ingredient group (AIG) number: 0259390002; AHFS:
APPROVED
2021-11-29
_ _ _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 ....................... Läs hela dokumentet