Approval · Notice of Compliance 17086 · 2015
FLOLAN: Notice of Compliance 17086
Issued July 14, 2015
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
- 17086
- Date
- July 14, 2015
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Nonprescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To add a ph 12 sterile diluent for use with flolan lyophilized powder
- 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