ApprovalTrail

Approval · Notice of Compliance 33933 · 2024

ZEPZELCA: Notice of Compliance 33933

Issued September 5, 2024

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
33933
Date
September 5, 2024
Company
Jazz Pharmaceuticals Ireland LimitedDublin, Dublin, Ireland
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Change in the manufacturing process for the drug substance

Products in this notice

BrandDINStatus today
ZEPZELCANot yet assigned—

Medicinal ingredients