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:
Approved
Current status date:
2014-05-02
Product name:
PROCHYMAL
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
American Hospital Formulary Service (AHFS): See footnote 3
Anatomical Therapeutic Chemical (ATC): See footnote 4
UNASSIGN UNASSIGNED
Active ingredient group (AIG) number:See footnote5
0153160001
| 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.
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |