ApprovalTrail

Approval · Notice of Compliance 26751 · 2021

ZEPZELCA: Notice of Compliance 26751

Issued September 29, 2021

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
26751
Date
September 29, 2021
Company
Jazz Pharmaceuticals Ireland LimitedDublin, Dublin, Ireland
Product type
Prescription Pharmaceutical
Submission
New Drug Submission (NDS)
Submission class
New Active Substance (NAS)
With conditions
Yes (NOC/c)

Products in this notice

BrandDINStatus today
ZEPZELCA02520834Dormant

Medicinal ingredients