Basic Information
Agamree
Regulatory Information
EMEA/H/C/005679
December 14, 2023
October 12, 2023
4
March 25, 2025
Company Information
Germany
Marie-Curie Strasse 8 79539 Lorrach
Santhera Pharmaceuticals (Deutschland) GmbH
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Agamree is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older.
Overview Summary
Agamree is a medicine for treating Duchenne muscular dystrophy in patients from 4 years of age. Duchenne muscular dystrophy is a genetic disease that gradually causes weakness and loss of muscle function. Duchenne muscular dystrophy is rare, and Agamree was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 22 August 2014. Further information on the orphan designation can be found on the EMA [website](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-14-1309). Agamree contains the active substance vamorolone.