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

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

DIN:

02484552

Product Monograph/Veterinary Labelling:

Date: 2024-02-28 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

List of active ingredient(s)
Active ingredient(s) 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
Version 4.0.2
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