ApprovalTrail

Approval · Notice of Compliance 35197 · 2025

LEDAGA: Notice of Compliance 35197

Issued April 15, 2025

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
35197
Date
April 15, 2025
Company
Recordati Rare Diseases Canada IncToronto, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Addition of a manufacturing site and/or manufacturer involving production of the drug substance. Ajout d'un site de fabrication ou d'un fabricant impliquant la fabrication de la substance médicamenteuse.

Products in this notice

BrandDINStatus today
LEDAGANot yet assigned—

Medicinal ingredients