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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:

2016-02-03

Original market date: See footnote 1

2016-02-03

Product name:

GENVOYA

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:

02449498

Product Monograph/Veterinary Labelling:

Date: 2021-08-06 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

GILEAD SCIENCES CANADA INC
600  6711 Mississauga Road
Mississauga
Ontario
Canada  L5N 2W3

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

4

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

08:18.08.12   HIV INTEGRASE INHIBITORS ,  08:18.08.20   NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Anatomical Therapeutic Chemical (ATC): See footnote 4

J05AR18  EMTRICITABINE,TENOFOVIR ALAFENAMIDE, ELVITEGRAVIR AND COBICISTAT

Active ingredient group (AIG) number:See footnote 5

0457610001

List of active ingredient(s)
Active ingredient(s) Strength
COBICISTAT 150 MG
ELVITEGRAVIR 150 MG
EMTRICITABINE 200 MG
TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) 10 MG

Risk Management Plans See footnote 7

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

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