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:
2021-12-06
Original market date: See footnote 1
2021-12-06
Product name:
ZEPZELCA
DIN:
02520834
Product Monograph/Veterinary Labelling:
Date:
2024-03-05
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
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
10:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01XX69 LURBINECTEDIN
Active ingredient group (AIG) number:See footnote5
0163176001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| LURBINECTEDIN | 4 MG / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.