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:
Approved
Current status date:
2026-01-15
Product name:
ZIIHERA
DIN:
02564610
Product Monograph/Veterinary Labelling:
Date:
2026-01-15
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
JAZZ PHARMACEUTICALS IRELAND LIMITED
5th Floor, Waterloo Exchange, Waterloo Rd.
Dublin
Dublin
Ireland
D04 E5W7
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
PRESCRIPTION , SCHEDULE D
American Hospital Formulary Service (AHFS): See footnote 3
10:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01FD07 ZANIDATAMAB
Active ingredient group (AIG) number:See footnote5
0168053001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ZANIDATAMAB | 300 MG / VIAL |