Approval · Notice of Compliance 21871 · 2019
FLOLAN: Notice of Compliance 21871
Issued February 19, 2019
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
- 21871
- Date
- February 19, 2019
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- To update the information on the type of diluent to be used for reconstitution
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