Active substance
Safinamide
- SFDA 2
- US FDA 5
- Health Canada 2
- NHS prices 2
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Xadago | 50 mg | Tablet · Oral use | 30 Blister | SAR 352.70 | NCE · Prescription | Zambon SpA | Valid |
| Xadago | 100 mg | Film-coated tablet · Oral use | 30 Blister | SAR 352.70 | NCE · Prescription | Zambon SpA | Valid |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| XADAGO | EQ 50MG BASE; EQ 100MG BASE | tablet · oral | MDD US | Prescription | 21 Mar 2017 |
| SAFINAMIDE MESYLATE | EQ 50MG BASE; EQ 100MG BASE | tablet · oral | PRINSTON INC | Prescription | 25 Apr 2024 |
| SAFINAMIDE MESYLATE | EQ 50MG BASE; EQ 100MG BASE | tablet · oral | MSN | Prescription | 31 Dec 2024 |
| SAFINAMIDE MESYLATE | EQ 50MG BASE; EQ 100MG BASE | tablet · oral | ZENARA | Prescription | 13 Jun 2025 |
| SAFINAMIDE MESYLATE | EQ 50MG BASE; EQ 100MG BASE | tablet · oral | AUROBINDO PHARMA | Discontinued | 14 Jun 2023 |
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| NHS Drug Tariff | Safinamide 100mg tablets | £69.00 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Safinamide 50mg tablets | £69.00 | 30 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 9 Aug 2021 XADAGO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.