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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:

2019-02-13

Product name:

YESCARTA

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:

02485648

Product Monograph/Veterinary Labelling:

Date: 2019-03-04 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

GILEAD SCIENCES CANADA INC
600  6711 Mississauga Road
Mississauga
Ontario
Canada  L5N 2W3

Class: 

Human

Dosage form(s):

Suspension

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription,  Schedule D  

American Hospital Formulary Service (AHFS): See footnote 3

10:00.00   ANTINEOPLASTIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

UNASSIGN  UNASSIGNED

Active ingredient group (AIG) number:See footnote 5

0161211001

List of active ingredient(s)
Active ingredient(s) Strength
AXICABTAGENE CILOLEUCEL 200000000 CELLS / BAG

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