Approval · Notice of Compliance 7560 · 2005
AVELOX: Notice of Compliance 7560
Issued October 28, 2005
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
- 7560
- Date
- October 28, 2005
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: treatment of community acquired pneumonia due to multi drug resistant streptococcus pneumoniae
- Therapeutic class
- Antibacterial agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AVELOX | Not yet assigned | — |
| AVELOX IV | Not yet assigned | — |
Medicinal ingredients
- MOXIFLOXACIN HYDROCHLORIDE 400 MG per TAB
- MOXIFLOXACIN HYDROCHLORIDE 400 MG per 250ML