EMEA-002559-PIP09-23 - paediatric investigation plan
Nipocalimab
PIPHuman
Key facts
- Active Substance
- Nipocalimab
- Therapeutic area
- Blood and lymphatic system disorders
- Decision number
- P/0032/2024
- PIP number
- EMEA-002559-PIP09-23
- Pharmaceutical form(s)
- Concentrate for solution for infusion
- Condition(s) / indication(s)
- Prevention of foetal and neonatal alloimmune thrombocytopenia
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
Janssen Cilag International
Email: contact@Janssen-emea.com
Tel. +32 14602111- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date