ApprovalTrail

Approval · Notice of Compliance 17043 · 2015

BOSULIF: Notice of Compliance 17043

Issued June 30, 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.

Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
Notice number
17043
Date
June 30, 2015
Company
Pfizer Canada UlcKirkland, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Update to the warnings and precautions, adverse reactions and dosage and administration sections of the product monograph
Therapeutic class
Protein-tyrosine kinase inhibitor
With conditions
Yes (NOC/c)

Products in this notice

BrandDINStatus today
BOSULIFNot yet assigned—

Medicinal ingredients