Approval · Notice of Compliance 18167 · 2016
FLOVENT DISKUS: Notice of Compliance 18167
Issued June 1, 2016
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
- 18167
- Date
- June 1, 2016
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To include new safety information in the product monograph regarding the use of fluticasone propionate (fp) during pregnancy and to remove the contraindication for moderate to severe brochiectasis
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLOVENT DISKUS | Not yet assigned | — |
| FLOVENT HFA | Not yet assigned | — |
Medicinal ingredients
- FLUTICASONE PROPIONATE 50 MCG per BLD
- FLUTICASONE PROPIONATE 100 MCG per BLD
- FLUTICASONE PROPIONATE 250 MCG per BLD
- FLUTICASONE PROPIONATE 500 MCG per BLD
- FLUTICASONE PROPIONATE 50 MCG per ACT
- FLUTICASONE PROPIONATE 125 MCG per ACT
- FLUTICASONE PROPIONATE 250 MCG per ACT