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:
Marketed
Current status date:
2011-07-28
Original market date: See footnote 1
2011-07-28
Product name:
BERIPLEX P/N 500
DIN:
02359251
Product Monograph/Veterinary Labelling:
Date:
2019-10-23
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
CSL BEHRING CANADA INC
350
55 Metcalfe Street
Ottawa
Ontario
Canada
K1P 6L5
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
6
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
20:28.16
Anatomical Therapeutic Chemical (ATC): See footnote 4
B02BD01 COAGULATION FACTOR IX, II, VII AND X IN COMB
Active ingredient group (AIG) number:See footnote5
0652205002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| COAGULATION FACTOR II (HUMAN) | 800 UNIT |
| COAGULATION FACTOR IX (HUMAN) | 620 UNIT |
| COAGULATION FACTOR VII (HUMAN) | 500 UNIT |
| COAGULATION FACTOR X (HUMAN) | 1020 UNIT |
| PROTEIN C | 820 UNIT |
| PROTEIN S | 680 UNIT |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.