ApprovalTrail

Approval · Notice of Compliance 18656 · 2016

KALYDECO: Notice of Compliance 18656

Issued November 9, 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
18656
Date
November 9, 2016
Company
Vertex Pharmaceuticals (Canada) IncorporatedToronto, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Additional drug product intermediate manufacturing site

Products in this notice

BrandDINStatus today
KALYDECONot yet assigned—

Medicinal ingredients