ApprovalTrail

Approval · Notice of Compliance 22261 · 2019

MVASI: Notice of Compliance 22261

Issued June 5, 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
22261
Date
June 5, 2019
Company
Amgen Canada IncMississauga, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: malignant giloma (who grade iv) - giloblastoma mvasi, in comnination with lomustine is indicated for the treatment of patients with giloblastoma after relapse or disease progression following prior therapy

Products in this notice

BrandDINStatus today
MVASINot yet assigned—

Medicinal ingredients