EMEA-002362-PIP02-19-M03 - paediatric investigation plan
fidanacogene elaparvovec
PIPHuman
Key facts
- Active Substance
- fidanacogene elaparvovec
- Therapeutic area
- Congenital, familial and genetic disorders
- Decision number
- P/0115/2024
- PIP number
- EMEA-002362-PIP02-19-M03
- Pharmaceutical form(s)
- Concentrate for solution for infusion
- Condition(s) / indication(s)
- Treatment of congenital factor IX deficiency (haemophilia B)
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
Pfizer Europe MA EEIG
Tel. +44 (0)1304 646 607
E-mail: pip_enquiries@pfizer.com- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date