Approval · Notice of Compliance 498 · 2002
FLOVENT HFA: Notice of Compliance 498
Issued September 30, 2002
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
- 498
- Date
- September 30, 2002
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: prophylactic management of steroid-responsive bronchial asthma in pediatric patients (12 months to 16 years)
- Therapeutic class
- Corticosteroid for oral inhalation
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLOVENT HFA | Not yet assigned | — |
Medicinal ingredients
- FLUTICASONE PROPIONATE 50 MCG per ACT