Approval · Notice of Compliance 19270 · 2017
AVELOX: Notice of Compliance 19270
Issued May 9, 2017
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
- 19270
- Date
- May 9, 2017
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To update the product monograph as part of class labelling changes for all fluoroquinolones with respect to permanent disabilities
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AVELOX | 02242965 | Cancelled Post Market |
| AVELOX I.V. | Not yet assigned | — |
Medicinal ingredients
- MOXIFLOXACIN 400 MG per MG
- MOXIFLOXACIN 0.436 MG per 250ML