Approval · Notice of Compliance 11372 · 2010
YONDELIS: Notice of Compliance 11372
Issued May 13, 2010
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
- 11372
- Date
- May 13, 2010
- Company
- Janssen-Ortho Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Antineoplastic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| YONDELIS | 02351501 | — |
| YONDELIS | 02351528 | Marketed |
Medicinal ingredients
- TRABECTEDIN 0.25 MG per VIAL
- TRABECTEDIN 1 MG per VIAL