ApprovalTrail

Approval · Notice of Compliance 14402 · 2013

BRILINTA: Notice of Compliance 14402

Issued May 23, 2013

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
14402
Date
May 23, 2013
Company
Astrazeneca Canada IncMississauga, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Revision to the drug substance design space upper boundary limit and the introduction of two new key process parameters to the design space
Therapeutic class
Platelet aggregation inhibitor

Products in this notice

BrandDINStatus today
BRILINTANot yet assigned—

Medicinal ingredients