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:
2019-09-12
Original market date: See footnote 1
2019-09-12
Product name:
PMS-EMTRICITABINE-TENOFOVIR
DIN:
02461110
Product Monograph/Veterinary Labelling:
Date:
2020-11-26
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
PHARMASCIENCE INC
100
6111 Royalmount Ave
Montreal
Quebec
Canada
H4P 2T4
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
J05AR03 TENOFOVIR DISOPROXIL AND EMTRICITABINE
Active ingredient group (AIG) number:See footnote5
0251568001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| EMTRICITABINE | 200 MG |
| TENOFOVIR DISOPROXIL FUMARATE | 300 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |
| Healthcare Professional Checklist |
| Patient Wallet Card |
| Patient Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Registry |