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The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2017-09-13

Original market date: See footnote 1

2017-09-13

Product name:

MAVIRET

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02467550

Product Monograph/Veterinary Labelling:

Date: 2021-03-17 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ABBVIE CORPORATION
8401 Trans-Canada Highway
Saint-Laurent
Quebec
Canada  H4S 1Z1

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

2

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

08:18.40.20   HCV Protease Inhibitors ,  08:18.40.24   HCV Replication Complex Inhibitors

Anatomical Therapeutic Chemical (ATC): See footnote 4

J05AP57  GLECAPREVIR AND PIBRENTASVIR

Active ingredient group (AIG) number:See footnote 5

0259390001

List of active ingredient(s)
Active ingredient(s) Strength
GLECAPREVIR 100 MG
PIBRENTASVIR 40 MG

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

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