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:
Dormant
Current status date:
2017-07-05
Original market date: See footnote 1
1997-12-15
Product name:
TRASYLOL
DIN:
02186845
Product Monograph/Veterinary Labelling:
Date:
2014-09-26
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
NORDIC GROUP B.V.
Siriusdreef 41
Hoofddorp
Noord-Holland
Netherlands
2132 WT
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
20:28.16
Anatomical Therapeutic Chemical (ATC): See footnote 4
B02AB01 APROTININ
Active ingredient group (AIG) number:See footnote5
0152585001
| Active ingredient(s) | Strength |
|---|---|
| APROTININ (BOVINE) | 10000 UNIT / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Controlled Distribution Program |
| Healthcare Professional Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Registry |