Exondys AVI Biopharma International Ltd · Refused · ATC M09AX
Therapeutic indication (EMA)
Treatment of Duchenne muscular dystrophy.
Active substance
Eteplirsen
- US FDA 1
- EMA 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| EXONDYS 51 | 100MG/2ML (50MG/ML); 500MG/10ML (50MG/ML) | solution · intravenous | SAREPTA THERAPS INC | Prescription | 19 Sep 2016 |
EMA European Union — centrally authorised medicines
Safety signals and safety-related labeling changes
- US FDA 18 Jan 2022 EXONDYS 51 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; 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.