Approval · Notice of Compliance 18696 · 2016
TREANDA: Notice of Compliance 18696
Issued November 25, 2016
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
- 18696
- Date
- November 25, 2016
- Company
- Lundbeck Canada IncSt-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the product monograph with informaition from a phase 1/2 study in pediatric patients with relapsed or refractory acute leukemia
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TREANDA | Not yet assigned | — |
Medicinal ingredients
- BENDAMUSTINE HYDROCHLORIDE 25 MG per VIAL
- BENDAMUSTINE HYDROCHLORIDE 100 MG per VIAL