Notice of Compliance Information
From Health Canada
- Notice of Compliance date :
- 1999-02-16
- Manufacturer :
- HOFFMANN-LA ROCHE LIMITED
- Product type:
- Biologic
- NOC with conditions:
- Yes
- Submission type:
- Supplement to a New Drug Submission (SNDS)
- Reason for supplement:
- NEW INDICATION FOR MANAGEMENT OF ACUTE ISCHEMIC STROKE
- Submission class:
- Other
- Therapeutic class:
- FIBRINOLYTIC AGENT
- Published Notes:
- CONDITIONS WERE MET ON JANUARY 26, 2005
Brand 1 of 1 :
ACTIVASE RT-PA
Product 1 of 2 :
Drug identification number:
Not Applicable
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intravenous Intravascular
| Ingredient | Strength |
|---|---|
| ALTEPLASE | 100 MG/VIAL |
Product 2 of 2 :
Drug identification number:
Not Applicable
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intravenous Intravascular
| Ingredient | Strength |
|---|---|
| ALTEPLASE | 50 MG/VIAL |