Approval · Notice of Compliance 22437 · 2019
OZURDEX: Notice of Compliance 22437
Issued July 22, 2019
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
- 22437
- Date
- July 22, 2019
- Company
- Allergan IncMarkham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- To update the part III: consumer information section of the product monograph (pm) to the new patient medication information (pmi) format, and to update the pm with new safety information in the post-market adverse drug reactions and the dosage and administration sections
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OZURDEX | Not yet assigned | — |
Medicinal ingredients
- DEXAMETHASONE 0.7 MG per IMP