Approval · Notice of Compliance 35487 · 2025
FIRDAPSE: Notice of Compliance 35487
Issued June 10, 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
- 35487
- Date
- June 10, 2025
- Company
- Kye Pharmaceuticals Inc.Mississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Product Monograph reformatted to the Master Template. Update to the Product Monograph with new safety information. Addition of new pediatric indication: Addition of a pediatric indication for the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in patients 6 years of age and older.]. Addition of new dosage form: Dosing instructions added specific for an oral suspension preparation for those patients that require dosages in less than 5 mg increments or who have difficulty swallowing or require feeding tubes. Change in recommended dose/dosing range
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FIRDAPSE | Not yet assigned | — |
Medicinal ingredients
- AMIFAMPRIDINE PHOSPHATE 10 MG per TAB