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:
Approved
Current status date:
2017-08-17
Product name:
FLEBOGAMMA 5%
Description:
ALSO KNOW AS IMMUNE GLOBULIN (HUMAN). SINGLE USE VIALS.SINGLE USE VIALS
DIN:
02467488
Product Monograph/Veterinary Labelling:
Date:
2017-08-17
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:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:04.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J06BA02 IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.
Active ingredient group (AIG) number:See footnote5
0106267002
| Active ingredient(s) | Strength |
|---|---|
| IMMUNOGLOBULIN (HUMAN) | 50 MG / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.