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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:

2015-08-21

Original market date: See footnote 1

2015-08-21

Product name:

ICLUSIG

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:

02437333

Product Monograph/Veterinary Labelling:

Date: 2019-08-09 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ARIAD PHARMACEUTICALS INC
40 Landsdowne Street
Cambridge
Massachusetts
United States  02139

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

10:00.00   ANTINEOPLASTIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

L01EA05  PONATINIB

Active ingredient group (AIG) number:See footnote 5

0156590001

List of active ingredient(s)
Active ingredient(s) Strength
PONATINIB (PONATINIB HYDROCHLORIDE) 15 MG

Risk Management Plans See footnote 7

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

Additional Risk Minimization Measures
Controlled Distribution Program
Healthcare Professional Education
Patient Consent
Patient Wallet Card

Application information

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