Radicava Mitsubishi Tanabe Pharma GmbH · Application withdrawn · ATC N07
Therapeutic indication (EMA)
Treatment of amyotrophic lateral sclerosis.
Active substance
Edaravone
- US FDA 10
- EMA 1
- Health Canada 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| RADICAVA ORS | 105MG/5ML | suspension · oral | SHIONOGI | Prescription | 12 May 2022 |
| EDARAVONE | 30MG/100ML (0.3MG/ML) | solution · intravenous | HIKMA PHARMS | Prescription | 6 May 2024 |
| EDARAVONE | 30MG/100ML (0.3MG/ML) | solution · intravenous | GLAND | Prescription | 6 May 2024 |
| EDARAVONE | 30MG/100ML (0.3MG/ML) | solution · intravenous | SANDOZ | Prescription | 23 Dec 2024 |
| EDARAVONE | 30MG/100ML (0.3MG/ML) | solution · intravenous | ZYDUS PHARMS | Prescription | 22 Jul 2026 |
| RADICAVA | 30MG/100ML (0.3MG/ML); 60MG/100ML (0.6MG/ML) | solution · intravenous | SHIONOGI | Discontinued | 5 May 2017 |
| EDARAVONE | 60MG/100ML (0.6MG/ML) | solution · intravenous | DR REDDYS | Discontinued | 6 May 2024 |
| EDARAVONE | 60MG/100ML (0.6MG/ML) | solution · intravenous | GLAND | Discontinued | 6 May 2024 |
| EDARAVONE | 30MG/100ML (0.3MG/ML) | solution · intravenous | LONG GROVE PHARMS | Discontinued | 6 May 2024 |
| EDARAVONE | 30MG/100ML (0.3MG/ML); 60MG/100ML (0.6MG/ML) | solution · intravenous | PHARMOBEDIENT | Discontinued | 31 Oct 2024 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| RADICAVA | 02532611 | 105 MG / 5 ML | SUSPENSION · ORAL | SHIONOGI INC. |
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.