Approval · Notice of Compliance 12492 · 2011
YONDELIS: Notice of Compliance 12492
Issued July 14, 2011
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
- 12492
- Date
- July 14, 2011
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: For the treatment of patients with metastatic liposarcoma or leiomyosarcoma after failure of prior anthracycline and ifosfamide chemotherapy
- Therapeutic class
- Antineoplastic Agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| YONDELIS | Not yet assigned | — |
Medicinal ingredients
- TRABECTEDIN 0.25 MG per VIAL
- TRABECTEDIN 1 MG per VIAL