Agamree Santhera Pharmaceuticals (Deutschland) GmbH · Authorised · authorised 14 Dec 2023 · ATC H02AB18
Therapeutic indication (EMA)
Agamree is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 2 years and older.
Active substance
Vamorolone
- US FDA 1
- EMA 1
- Health Canada 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| AGAMREE | 40MG/ML | suspension · oral | CATALYST PHARMS | Prescription | 26 Oct 2023 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AGAMREE | 02561506 | 40 MG / ML | SUSPENSION · ORAL | KYE PHARMACEUTICALS INC. |
Safety signals and safety-related labeling changes
- US FDA 5 Jun 2024 AGAMREE — safety-related labeling change
Labeling sections changed: Warnings and Precautions
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.