ApprovalTrail

Approval · Notice of Compliance 32223 · 2023

LEFLUNOMIDE: Notice of Compliance 32223

Issued November 30, 2023

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
32223
Date
November 30, 2023
Company
Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Abbreviated New Drug Submission (ANDS)
Submission class
Admin
Reason
Administrative: Licensing Agreement Between Two Manufacturers
Canadian reference product
ARAVA (Aventis Pharma Inc.)

Products in this notice

BrandDINStatus today
LEFLUNOMIDE02543575Marketed
LEFLUNOMIDE02543583Marketed

Medicinal ingredients