Product information
From Health Canada
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:
2016-06-03
Original market date: See footnote 1
2016-06-03
Product name:
DESCOVY
DIN:
02454416
Product Monograph/Veterinary Labelling:
Date:
2022-08-05
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
GILEAD SCIENCES CANADA INC
400
6925 Century Avenue
Mississauga
Ontario
Canada
L5N 7K2
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
2
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
08:18.08.20
Anatomical Therapeutic Chemical (ATC): See footnote 4
J05AR17 EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Active ingredient group (AIG) number:See footnote5
0258111001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| 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.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Checklist |
| Patient Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Registry |