EMEA-001794-PIP02-16-M06 - paediatric investigation plan
Vamorolone
PIPHuman
Key facts
- Invented name
- Agamree
- Active Substance
- Vamorolone
- Therapeutic area
- Other
- Decision number
- P/0515/2023
- PIP number
- EMEA-001794-PIP02-16-M06
- Pharmaceutical form(s)
- Oral suspension
- Condition(s) / indication(s)
- Treatment of Duchenne muscular dystrophy
- Route(s) of administration
- Oral use
- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date