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:
2022-02-16
Original market date: See footnote 1
2022-02-16
Product name:
VISTASEAL
Description:
PREFILLED SYRINGES
DIN:
02514257
Product Monograph/Veterinary Labelling:
Date:
2021-03-25
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
INSTITUTO GRIFOLS S.A.
Poligono Levante. C/ Can Guasch, 2
Parets Del Valles
Barcelona
Spain
08150
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Topical
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
B02BC30 COMBINATIONS
Active ingredient group (AIG) number:See footnote5
0252708002
| Active ingredient(s) | Strength |
|---|---|
| FIBRINOGEN (HUMAN) | 400 MG / 5 ML |
| THROMBIN (HUMAN) | 2500 UNIT / 5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |