ApprovalTrail

Approval · Notice of Compliance 37664 · 2026

KEYTRUDA: Notice of Compliance 37664

Issued June 5, 2026

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
37664
Date
June 5, 2026
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 enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

Products in this notice

BrandDINStatus today
KEYTRUDANot yet assigned—

Medicinal ingredients