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:
2024-04-17
Original market date: See footnote 1
2017-07-26
Product name:
CERDELGA
DIN:
02463261
Product Monograph/Veterinary Labelling:
Date:
2024-04-17
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SANOFI-AVENTIS CANADA INC
1755 Steeles Avenue West
Toronto
Ontario
Canada
M2R 3T4
Class:
Human
Dosage form(s):
Capsule
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
92:92.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
A16AX10 ELIGLUSTAT
Active ingredient group (AIG) number:See footnote5
0158970001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ELIGLUSTAT (ELIGLUSTAT TARTRATE) | 84 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |
| Patient Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Drug Utilisation Study (DUS) |