ApprovalTrail

Approval · Notice of Compliance 16368 · 2014

EYLEA: Notice of Compliance 16368

Issued November 28, 2014

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
16368
Date
November 28, 2014
Company
Bayer Inc.Elkhart, Indiana, United States
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: eylea is indicated for the treatment of diabetic macular edema (dme)
Therapeutic class
Ohthalmological/antineovascularization agent

Products in this notice

BrandDINStatus today
EYLEA02415992Marketed

Medicinal ingredients