Approval · Notice of Compliance 1762 · 1999
FLOLAN: Notice of Compliance 1762
Issued August 18, 1999
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
- 1762
- Date
- August 18, 1999
- Company
- Glaxo Wellcome Inc.Mississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: for the treatment of secondary pulmonary hypertension due to scleroderma due to scleroderma spectrum of diseases (ssd)
- Therapeutic class
- Vasodilator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLOLAN | Not yet assigned | — |
Medicinal ingredients
- EPOPROSTENOL SODIUM 0.5 MG per VIAL
- EPOPROSTENOL SODIUM 1.5 MG per VIAL