ApprovalTrail

Approval · Notice of Compliance 25200 · 2021

ROPINIROLE: Notice of Compliance 25200

Issued February 11, 2021

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
25200
Date
February 11, 2021
Company
Sanis Health Inc.Brampton, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to an Abbreviated New Drug Submission (SANDS), supplement
Submission class
Other
Reason
Updated labelling materials and label update to match licensor
Canadian reference product
REQUIP (Glaxosmithkline Inc)

Products in this notice

BrandDINStatus today
ROPINIROLENot yet assigned—

Medicinal ingredients