Product information

From Health Canada

New search

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:

2008-07-08

Original market date: See footnote 1

2008-07-08

Product name:

OCTAPLEX

Description:

HUMAN PROTHROMBIN COMPLEX. 20ML RECONSTITUTED.

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:

02294664

Product Monograph/Veterinary Labelling:

Date: 2017-11-03 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H
Oberlaaer Strasse 235
Vienna
Vienne
Austria  1100

Class: 

Human

Dosage form(s):

Powder For Solution,  Kit

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

0652205003

List of active ingredient(s)
Active ingredient(s) Strength
COAGULATION FACTOR II (HUMAN) 760 UNIT / VIAL
COAGULATION FACTOR IX (HUMAN) 500 UNIT / VIAL
COAGULATION FACTOR VII (HUMAN) 480 UNIT / VIAL
COAGULATION FACTOR X (HUMAN) 600 UNIT / VIAL
PROTEIN C 620 UNIT / VIAL
PROTEIN S 640 UNIT / VIAL

Application information

Related information

Contact us

Version 3.8.0
Date modified: