Approval · Notice of Compliance 21771 · 2019
CIPRODEX: Notice of Compliance 21771
Issued January 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
- 21771
- Date
- January 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 decrease the font size on the ciprodex package leaflet and to revise the sample labels (1.5ml) to align with the approved trade labels (7.5ml) submitted in and admin-nds
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CIPRODEX | Not yet assigned | — |
Medicinal ingredients
- DEXAMETHASONE 0.1 PER
- CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE 0.3 PER