Approval · Notice of Compliance 22880 · 2019
BAVENCIO: Notice of Compliance 22880
Issued November 6, 2019
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
- 22880
- Date
- November 6, 2019
- Company
- Emd Serono A Division Of Emd Inc CanadaMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expansion of indication: Bavencio (avelumab for injection) is indicated for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC)
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BAVENCIO | Not yet assigned | — |
Medicinal ingredients
- AVELUMAB 20 MG per ML