ApprovalTrail

Approval · Notice of Compliance 25219 · 2021

TEVA-ABIRATERONE: Notice of Compliance 25219

Issued February 16, 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.

Notice number
25219
Date
February 16, 2021
Company
Teva Canada LimitedToronto, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to an Abbreviated New Drug Submission (SANDS), supplement
Submission class
Other
Reason
Safety updates to the Product Monograph
Canadian reference product
ZYTIGA (Janssen Inc.)

Products in this notice

BrandDINStatus today
TEVA-ABIRATERONENot yet assigned—

Medicinal ingredients