Approval · Notice of Compliance 36623 · 2025
MELPHALAN FOR INJECTION: Notice of Compliance 36623
Issued December 23, 2025
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
- 36623
- Date
- December 23, 2025
- Company
- Auro Pharma Inc.Woodbridge, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Update to Product Monograph (to align with CRP approved PM). Update to package labels. Addition of new route of administration: Intra-Arterial
- Canadian reference product
- AKERAN
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MELPHALAN FOR INJECTION | 02508214 | Approved |
Medicinal ingredients
- BUFFER SOLUTION 10 MG per VIAL
- MELPHALAN 50 MG per VIAL