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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:

2013-11-21

Original market date: See footnote 1

2013-11-21

Product name:

BERIPLEX P/N 1000

Description:

FACTOR II 760-1600IU,FACTOR VII 400-1000IU,FACTOR IX 800-1240IU,FACTOR X 1000-2040IU,PROTEIN C 840-1640IU,PROTEIN S 480-1360IU

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:

02410826

Product Monograph/Veterinary Labelling:

Date: 2019-10-23 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

CSL BEHRING CANADA INC
1460  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  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

20:28.16   HEMOSTATICS

Anatomical Therapeutic Chemical (ATC): See footnote 4

B02BD01  COAGULATION FACTOR IX, II, VII AND X IN COMB

Active ingredient group (AIG) number:See footnote 5

0652205004

List of active ingredient(s)
Active ingredient(s) Strength
COAGULATION FACTOR II (HUMAN) 1600 UNIT
COAGULATION FACTOR IX (HUMAN) 1240 UNIT
COAGULATION FACTOR VII (HUMAN) 1000 UNIT
COAGULATION FACTOR X (HUMAN) 2040 UNIT
PROTEIN C 1640 UNIT
PROTEIN S 1360 UNIT

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