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:
2019-10-17
Original market date: See footnote 1
2019-10-17
Product name:
LOKELMA
DIN:
02490714
Product Monograph/Veterinary Labelling:
Date:
2023-12-07
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ASTRAZENECA CANADA INC
1004 Middlegate Road, Suite 5000
Mississauga
Ontario
Canada
L4Y 1M4
Class:
Human
Dosage form(s):
Powder For Suspension
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
40:18.18
Anatomical Therapeutic Chemical (ATC): See footnote 4
V03AE10 SODIUM ZIRCONIUM CYCLOSILICATE
Active ingredient group (AIG) number:See footnote5
0161670001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| SODIUM ZIRCONIUM CYCLOSILICATE | 5 G / SACHET |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.