ApprovalTrail

Approval · Notice of Compliance 19625 · 2017

BOSULIF: Notice of Compliance 19625

Issued August 3, 2017

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
19625
Date
August 3, 2017
Company
Pfizer Canada UlcKirkland, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Fulfilment of the Post-Approval Commitments for the Notice of Compliance with conditions for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior TKI therapy

Products in this notice

BrandDINStatus today
BOSULIFNot yet assigned—

Medicinal ingredients