Approval · Notice of Compliance 2221 · 2001
FLOLAN: Notice of Compliance 2221
Issued August 7, 2001
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 2221
- Date
- August 7, 2001
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Nonprescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Change in manufacturer name
- Therapeutic class
- Vasodilator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLOLAN | 02230845 | Marketed |
| FLOLAN | 02230848 | Marketed |
| STERILE DILUENT FOR FLOLAN INJECTION | 02230857 | Cancelled Post Market |
Medicinal ingredients
- EPOPROSTENOL SODIUM 0.5 MG per VIAL
- EPOPROSTENOL SODIUM 1.5 MG per VIAL
- GLYCINE 94 MG per VIAL
- SODIUM CHLORIDE 73 MG per VIAL
- WATER 50 ML per VIAL