Approval · Notice of Compliance 19635 · 2017
HALAVEN: Notice of Compliance 19635
Issued August 4, 2017
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
- 19635
- Date
- August 4, 2017
- Company
- Eisai LimitedWoodcliff Lake, New Jersey, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: For the treatment of adult patients with an unresectable advanced or metastatic liposarcoma subtype of soft tissue sarcoma. Prior therapy should have included an anthracycline-containing regimen, unless not clinically appropriate.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HALAVEN | Not yet assigned | — |
Medicinal ingredients
- ERIBULIN MESYLATE 0.5 MG per ML