ApprovalTrail

Approval · Notice of Compliance 11126 · 2010

ZAVESCA: Notice of Compliance 11126

Issued March 4, 2010

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
11126
Date
March 4, 2010
Company
Actelion Pharmaceuticals LtdAllschwil, Basel-Landschaft, Switzerland
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: To slow the progression of some of the neurological manifestations in patients with Niemann-Pick Type C disease
Therapeutic class
Glucosyceramide synthase inhibitor

Products in this notice

BrandDINStatus today
ZAVESCANot yet assigned—

Medicinal ingredients