Approval · Notice of Compliance 16065 · 2014
LOVENOX: Notice of Compliance 16065
Issued September 9, 2014
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
- 16065
- Date
- September 9, 2014
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New drug substance manufacturing facility. increase in batch size of enoxaparin sodium intermediate
- Therapeutic class
- Anticoagulant - antithrombotic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LOVENOX | Not yet assigned | — |
| LOVENOX HP | Not yet assigned | — |
| LOVENOX WITH PRESERVATIVE 300MG/3ML | Not yet assigned | — |
Medicinal ingredients
- ENOXAPARIN SODIUM 100 MG per ML
- ENOXAPARIN SODIUM 150 MG per ML