Approval · Notice of Compliance 12965 · 2012
BUSULFEX: Notice of Compliance 12965
Issued January 24, 2012
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
- 12965
- Date
- January 24, 2012
- Company
- Otsuka Pharmaceutical Co LtdChiyoda-Ku Tokyo, Japan
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expanding the package insert in order to provide additonal imformation to the clinicians
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BUSULFEX | Not yet assigned | — |
Medicinal ingredients
- BUSULFAN 6 MG per ML