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
Product name:
LUTATHERA
Description:
SINGLE-DOSE VIAL
DIN:
02484552
Product Monograph/Veterinary Labelling:
Date:
2024-09-16
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
NOVARTIS PHARMACEUTICALS CANADA INC
100
700 Rue Saint-Hubert
Montreal
Quebec
Canada
H2Y 0C1
Class:
Radiopharmaceutical
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Schedule C
American Hospital Formulary Service (AHFS): See footnote 3
10:00.00 , 78:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
V10XX04 LUTETIUM (177Lu) OXODOTREOTIDE
Active ingredient group (AIG) number:See footnote5
0161130001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| LUTETIUM (177LU) OXODOTREOTIDE | 370 MBq / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Patient Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |