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:

2015-12-22

Original market date: See footnote 1

2015-12-22

Product name:

NUWIQ

Description:

ANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED). SINGLE USE VIAL & 2.5ML PREFILLED DILUENT SYRINGE

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:

02432994

Product Monograph/Veterinary Labelling:

Date: 2023-06-16 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):

2

Schedule(s):

Schedule D

 

American Hospital Formulary Service (AHFS): See footnote 3

20:28.16 

Anatomical Therapeutic Chemical (ATC): See footnote 4

B02BD02 COAGULATION FACTOR VIII

Active ingredient group (AIG) number:See footnote5

0256190004

List of active ingredient(s)
Active ingredient(s) Strength
SIMOCTOCOG ALFA 2000 UNIT / VIAL
WATER 2.5 ML / SYR

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

Pharmacovigilance/Monitoring Activity
Clinical Trials
Registry
Observational Studies
Version 4.0.2
Date modified: