Approval · Notice of Compliance 18166 · 2016
ADVAIR: Notice of Compliance 18166
Issued June 2, 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
- 18166
- Date
- June 2, 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 fluticonase propionate (fp) during pregnancy and to remove the contraindication for moderate to severe brochiectasis
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ADVAIR | Not yet assigned | — |
| ADVAIR DISKUS | Not yet assigned | — |
Medicinal ingredients
- FLUTICASONE PROPIONATE 125 MCG per ACT
- SALMETEROL XINAFOATE 25 MCG per ACT
- FLUTICASONE PROPIONATE 250 MCG per ACT
- FLUTICASONE PROPIONATE 100 MCG per BLD
- SALMETEROL XINAFOATE 50 MCG per BLD
- FLUTICASONE PROPIONATE 250 MCG per BLD
- FLUTICASONE PROPIONATE 500 MCG per BLD