ApprovalTrail

Approval · Notice of Compliance 27948 · 2022

KEYTRUDA: Notice of Compliance 27948

Issued April 7, 2022

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
27948
Date
April 7, 2022
Company
Merck Canada IncKirkland, Quebec, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Priority
Reason
New indication : Keytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD¿L1 (CPS¿1) as determined by a validated test.

Products in this notice

BrandDINStatus today
KEYTRUDANot yet assigned—

Medicinal ingredients