EMEA-001944-PIP01-16-M05 - paediatric investigation plan | European Medicines Agency (EMA)
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EMEA-001944-PIP01-16-M05 - paediatric investigation plan
vadadustat
PIPHuman
Key facts
Invented name
Vafseo
Active Substance
vadadustat
Therapeutic area
Blood and lymphatic system disorders
Decision number
P/0290/2024
PIP number
EMEA-001944-PIP01-16-M05
Pharmaceutical form(s)
Tablet
Age appropriate oral formulation
Condition(s) / indication(s)
Treatment of anaemia due to chronic disorders
Route(s) of administration
Oral use
Contact for public enquiries
Akebia Europe Limited E-mail: info@akebia.com Tel. +1 6178712098
Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Decision
P/0290/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for vadadustat (Vafseo), (EMEA-001944-PIP01-16-M05)