Approval · Notice of Compliance 16865 · 2015
OZURDEX: Notice of Compliance 16865
Issued April 16, 2015
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
- 16865
- Date
- April 16, 2015
- Company
- Allergan IncMarkham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Approval of a new indication for ozdurex as follows: ozdurex is indicated for the treatment of diabetic macular edema (dme)
- Therapeutic class
- Corticosteroid
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OZURDEX | Not yet assigned | — |
Medicinal ingredients
- DEXAMETHASONE 700 MCG per POR