ApprovalTrail

Approval · Notice of Compliance 31191 · 2023

CELEXA: Notice of Compliance 31191

Issued July 10, 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
31191
Date
July 10, 2023
Company
Lundbeck Canada IncSt-Laurent, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Update the Product Monograph (PM) with safety information following an update to Lundbeck¿s Company Core Data Sheet (CCDS) for citalopram regarding hyperprolactinemia.

Products in this notice

BrandDINStatus today
CELEXANot yet assigned—

Medicinal ingredients