ApprovalTrail

Approval · Notice of Compliance 22363 · 2019

KEYTRUDA: Notice of Compliance 22363

Issued July 4, 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
22363
Date
July 4, 2019
Company
Merck Canada IncKirkland, Quebec, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: keytruda, in combination with carboplatin and either peclitaxel or nab-paclitaxel is indicated for the treatment of metastatic squamous nsclc in adults with no prior systemicc chemotherapy treatment for metastatic nsclc

Products in this notice

BrandDINStatus today
KEYTRUDANot yet assigned—

Medicinal ingredients