Approval · Notice of Compliance 9119 · 2007
ADVAIR: Notice of Compliance 9119
Issued October 18, 2007
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
- 9119
- Date
- October 18, 2007
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revisions to the product monograph to be consistent with canadian asthma consensus guidelines (december 2004) by emphasizing that laba-containing products should be used only as additional therapy for patients not adequately controlled on low-to medium-dose inhaled corticosteroids, and to further describe the results of the salmeterol multi-center asthma research trial
- Therapeutic class
- Bronchodilator and corticosteroid for oral inhalation
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ADVAIR | Not yet assigned | — |
| ADVAIR DISKUS | Not yet assigned | — |
Medicinal ingredients
- SALMETEROL XINAFOATE 25 MCG per ACT
- FLUTICASONE PROPIONATE 50 MCG per ACT
- FLUTICASONE PROPIONATE 125 MCG per ACT
- FLUTICASONE PROPIONATE 250 MCG per ACT
- SALMETEROL XINAFOATE 50 MCG per ACT
- FLUTICASONE PROPIONATE 100 MCG per ACT
- FLUTICASONE PROPIONATE 500 MCG per ACT