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:

Cancelled Post Market

Current status date:

2022-01-14

Original market date: See footnote 1

2019-02-27

Lot number: See footnote 2

CKMHK

Expiry date: See footnote 2

2023-09-30

Product name:

IDHIFA

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:

02485435

Product Monograph/Veterinary Labelling:

Date: 2020-11-30 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

CELGENE INC
300 2344 Alfred-Nobel Boulevard
Saint-Laurent
Quebec
Canada H4S 0A4

Class:

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

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

L01XX59 ENASIDENIB

Active ingredient group (AIG) number:See footnote5

0161190002

List of active ingredient(s)
Active ingredient(s) Strength
ENASIDENIB (ENASIDENIB MESYLATE) 100 MG

Risk Management Plans See footnote 7

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

Additional Risk Minimization Measures
Patient Wallet Card
Version 4.0.2
Date modified: