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:

2023-08-17

Original market date: See footnote 1

2017-10-04

Product name:

ONIVYDE

Description:

LIPOSOMES FOR INJECTION. SINGLE USE 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:

02467135

Product Monograph/Veterinary Labelling:

Date: 2023-08-17 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

IPSEN BIOPHARMACEUTICALS CANADA INC
SUITE 500 5050 Satellite Drive
Mississauga
Ontario
Canada L4W 0G1

Class:

Human

Dosage form(s):

Suspension

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

L01CE02 IRINOTECAN

Active ingredient group (AIG) number:See footnote5

0159330001

List of active ingredient(s)
Active ingredient(s) Strength
IRINOTECAN (IRINOTECAN SUCROSE OCTASULFATE) 4.3 MG / ML

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

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