Key facts
- Invented name
- Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
- Active Substance
- Dinutuximab beta
- Therapeutic area
- Oncology
- Decision number
- P/0076/2024
- PIP number
- EMEA-001314-PIP01-12-M02
- Pharmaceutical form(s)
- Solution for infusion
- Concentrate for solution for infusion
- Powder and solvent for solution for injection
- Powder for solution for infusion
- Condition(s) / indication(s)
- Treatment of neuroblastoma
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
EUSA Pharma (Netherlands) B.V.
Tel. +44 (0)3305 001155
E-mail: Ignacio.AlvarezRojo@eusapharma.comRecordati Rare Diseases
Tel. +33 1 47 73 64 58
E-mail: RRDinfo@recordati.com
- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date