ApprovalTrail

Approval · Notice of Compliance 28539 · 2022

KEYTRUDA: Notice of Compliance 28539

Issued July 5, 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
28539
Date
July 5, 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 : Melanoma KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection.

Products in this notice

BrandDINStatus today
KEYTRUDANot yet assigned—

Medicinal ingredients