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:
2022-09-15
Original market date: See footnote 1
2022-09-15
Product name:
ESPEROCT
DIN:
02490102
Product Monograph/Veterinary Labelling:
Date:
2023-09-11
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
NOVO NORDISK CANADA INC
101-2476 Argentia Road
Mississauga
Ontario
Canada
L5N 6M1
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
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
0161610005
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED | 3000 UNIT / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Registry |