ApprovalTrail

Approval · Notice of Compliance 16504 · 2015

BICALUTAMIDE: Notice of Compliance 16504

Issued January 8, 2015

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
16504
Date
January 8, 2015
Company
Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Abbreviated New Drug Submission (ANDS)
Submission class
Admin
Reason
Licensing agreement between two companies
Therapeutic class
Non-steroidal antiandrogen
Canadian reference product
CASODEX (Astrazeneca Canada Inc)

Products in this notice

BrandDINStatus today
BICALUTAMIDE02382423Cancelled Post Market

Medicinal ingredients