Approval · Notice of Compliance 20041 · 2017
OPDIVO: Notice of Compliance 20041
Issued November 10, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 20041
- Date
- November 10, 2017
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication: Classical Hodgkin Lymphoma (cHL): OPDIVO as monotherapy is indicated for the treatment of adult patients with classical Hodgkin Lymphoma (cHL) that has relapsed or progressed after: autologous stem cell transplantation (ASCT) and brentuximab vedotin, or three or more lines of systemic therapy including ASCT
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPDIVO | Not yet assigned | — |