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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:

Approved

Current status date:

2021-05-26

Product name:

ABECMA

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:

02516233

Product Monograph/Veterinary Labelling:

Date: 2021-07-30 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):

Suspension

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Schedule D,  Prescription  

American Hospital Formulary Service (AHFS): See footnote 3

26:12.00   GENE THERAPY

Anatomical Therapeutic Chemical (ATC): See footnote 4

L01X  OTHER ANTINEOPLASTIC AGENTS

Active ingredient group (AIG) number:See footnote 5

0162927001

List of active ingredient(s)
Active ingredient(s) Strength
IDECABTAGENE VICLEUCEL 520000000 CELLS

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