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:
2016-07-15
Original market date: See footnote 1
1996-08-28
Product name:
WINRHO SDF
Description:
ALSO KNOWN AS RHO D IMMUNE GLOBULIN HUMAN
DIN:
02217449
Product Monograph/Veterinary Labelling:
Date:
2016-05-20
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
APTEVO BIOTHERAPEUTICS LLC
920 Cassatt Road, Suite 100
Berwyn
Pennsylvania
United States
19312
Class:
Human
Dosage form(s):
Kit
Route(s) of administration:
Intravenous , Intramuscular
Number of active ingredient(s):
1
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:04.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J06BB01 ANTI-D (RH) IMMUNOGLOBULIN
Active ingredient group (AIG) number:See footnote5
0106269004
| Active ingredient(s) | Strength |
|---|---|
| ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) | 1500 UNIT / KIT |