ApprovalTrail

Approval · Notice of Compliance 22188 · 2019

TECENTRIQ: Notice of Compliance 22188

Issued May 24, 2019

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
22188
Date
May 24, 2019
Company
Hoffmann-La Roche LimitedMississauga, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: tecentriq in combination with bevacizumab, paclitaxel and carboplatin for the first line treatment of adult patients with metastatic non-squamish non-small cell lung cancer (nsclc) with no egfr or alk genomic tumor aberrations and no prior systemic chemotherapy treatment for metastatic non-squamish nsclc

Products in this notice

BrandDINStatus today
TECENTRIQNot yet assigned—

Medicinal ingredients