Product information
From Health Canada
No match found
No other product was found with the same active ingredient group.
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:
Dormant
Current status date:
2023-07-31
Original market date: See footnote 1
2018-07-25
Product name:
NUWIQ
Description:
ANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED). SINGLE USE VIAL & 2.5ML PREFILLED DILUENT SYRINGE
DIN:
02474050
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
AUTRICHE
1100
Class:
Humain
Dosage form(s):
Trousse , Poudre pour solution
Route(s) of administration:
Intraveineuse
Number of active ingredient(s):
2
Schedule(s):
Annexe 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
0256190006
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| Simoctocog alfa | 3000 Unité / Fiole |
| Eau | 2.5 ML / Seringue |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Essais cliniques |
| Registre |
| Études observationnelles |