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:
2016-09-26
Original market date: See footnote 1
2012-05-01
Product name:
FERAHEME
Description:
FOR I.V. USE ONLY. 510MG/17ML SINGLE USE VIALS
DIN:
02377217
Product Monograph/Veterinary Labelling:
Date:
2015-06-05
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
AMAG PHARMACEUTICALS INC
1100 Winter Street
Waltham
Massachusetts
United States
02415
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
20:04.04
Anatomical Therapeutic Chemical (ATC): See footnote 4
B03AC IRON, PARENTERAL PREPARATIONS
Active ingredient group (AIG) number:See footnote5
0108536002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| IRON (FERUMOXYTOL) | 30 MG / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.