Product information

From Health Canada

New search

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:

2014-05-02

Product name:

PROCHYMAL

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:

02386380

Product Monograph/Veterinary Labelling:

Date: 2014-03-06 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

MESOBLAST INTERNATIONAL SARL
505 Fifth Avenue, Level 3
New York
New York
United States  10017

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription,  Schedule D  

 

Anatomical Therapeutic Chemical (ATC): See footnote 4

UNASSIGN  UNASSIGNED

Active ingredient group (AIG) number:See footnote 5

0153160001

List of active ingredient(s)
Active ingredient(s) Strength
REMESTEMCEL-L 100000000 UNIT / 15 ML

Risk Management Plans See footnote 7

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

Application information

Related information

Contact us

Version 3.9.2
Date modified: