Approval · Notice of Compliance 32963 · 2024
FLOLAN: Notice of Compliance 32963
Issued March 26, 2024
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
- 32963
- Date
- March 26, 2024
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the storage temperature and the in-use period. Update to the Product Monograph. Product Monograph reformatted to the Master Template. Update to the package insert
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLOLAN | Not yet assigned | — |
| PH 12 STERILE DILUENT FOR FLOLAN | Not yet assigned | — |
Medicinal ingredients
- EPOPROSTENOL SODIUM 0.5 MG per VIAL
- EPOPROSTENOL SODIUM 1.5 MG per VIAL
- GLYCINE 94 MG per VIAL
- SODIUM CHLORIDE 73.3 MG per VIAL
- WATER 50 ML per VIAL