Approval · Notice of Compliance 22078 · 2019
TOBRADEX: Notice of Compliance 22078
Issued April 17, 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
- 22078
- Date
- April 17, 2019
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- To introduce a reduction of text font size for the outer label as a result of previously approved manufacturing site additions
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TOBRADEX | Not yet assigned | — |
Medicinal ingredients
- DEXAMETHASONE 0.1 PER
- TOBRAMYCIN 0.3 PER