Approval · Notice of Compliance 16376 · 2014
ALKERAN: Notice of Compliance 16376
Issued November 28, 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
- 16376
- Date
- November 28, 2014
- Company
- Aspri Pharma Canada Inc.Concord, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Antineoplastic (alkylating) agent
Products in this notice
Medicinal ingredients
- BUFFER SOLUTION 10 ML per VIAL
- MELPHALAN HCL 50 MG per VIAL
- MELPHALAN 2 MG per TAB