ApprovalTrail

Approval · Notice of Compliance 27290 · 2021

POLIVY: Notice of Compliance 27290

Issued December 24, 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
27290
Date
December 24, 2021
Company
Hoffmann-La Roche LimitedMississauga, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Fulfillment of comment #3 of the Letter of Undertaking dated June 16, 2020
With conditions
Yes (NOC/c)

Products in this notice

BrandDINStatus today
POLIVYNot yet assigned—

Medicinal ingredients