Approval · Notice of Compliance 38304 · 2026
EPKINLY: Notice of Compliance 38304
Issued September 17, 2026
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
- 38304
- Date
- September 17, 2026
- Company
- AbbVie CorporationSaint-Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: EPKINLY (epcoritamab injection / epcoritamab for injection) is indicated: In combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory Grade 1, 2, or 3a follicular lymphoma (FL) who have received at least one prior line of systemic therapy
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EPKINLY | Not yet assigned | — |
Medicinal ingredients
- EPCORITAMAB 5 MG per ML
- EPCORITAMAB 60 MG per ML