ApprovalTrail

Approval · Notice of Compliance 11196 · 2010

EBIXA: Notice of Compliance 11196

Issued March 24, 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
11196
Date
March 24, 2010
Company
Lundbeck Canada IncSt-Laurent, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Revision of the dosing recommendations in renal impairment and creation of a Consumer Information Leaflet
Therapeutic class
N-methyl-D-aspartate (NMDA) receptor antagonist

Products in this notice

BrandDINStatus today
EBIXANot yet assigned—

Medicinal ingredients