Approval · Notice of Compliance 34258 · 2024
NAROPIN: Notice of Compliance 34258
Issued October 22, 2024
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
- 34258
- Date
- October 22, 2024
- Company
- Aspen Pharmacare Canada Inc.Oakville, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a drug product manufacturing site. Change in the batch size for the drug product. Update to package labels
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| NAROPIN | Not yet assigned | — |
Medicinal ingredients
- ROPIVACAINE HYDROCHLORIDE 5 MG per ML
- ROPIVACAINE HYDROCHLORIDE 10 MG per ML