ApprovalTrail

Approval · Notice of Compliance 37804 · 2026

ZEPZELCA: Notice of Compliance 37804

Issued June 29, 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
37804
Date
June 29, 2026
Company
Jazz Pharmaceuticals Ireland LimitedDublin, Dublin, Ireland
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Addition of new indication: ZEPZELCA (lurbinectedin) is indicated in combination with atezolizumab for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed following first-line induction therapy with atezolizumab, carboplatin and etoposide

Products in this notice

BrandDINStatus today
ZEPZELCANot yet assigned—

Medicinal ingredients