ApprovalTrail

Approval · Notice of Compliance 34382 · 2024

BLEXTEN: Notice of Compliance 34382

Issued November 15, 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
34382
Date
November 15, 2024
Company
Aralez Pharmaceuticals Canada Inc.Toronto, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Addition of a manufacturing site and/or manufacturer involving production of the starting material. Change in the specification for the drug substance.Change in the manufacturing process for the starting material. Addition of a manufacturing site and/or manufacturer involving production of the drug substance

Products in this notice

BrandDINStatus today
BLEXTENNot yet assigned—

Medicinal ingredients