ApprovalTrail

Approval · Notice of Compliance 17784 · 2016

VISANNE: Notice of Compliance 17784

Issued February 18, 2016

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
17784
Date
February 18, 2016
Company
Bayer Inc.Elkhart, Indiana, United States
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Revised indication to include management of pain associated with endometriosis in pediatric patients under the age of 18 and after menarche

Products in this notice

BrandDINStatus today
VISANNENot yet assigned—

Medicinal ingredients