EMEA-002665-PIP02-20-M01 - paediatric investigation plan
Loncastuximab tesirine
PIPHuman
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Key facts
- Invented name
- Zynlonta
- Active substance
- Loncastuximab tesirine
- Therapeutic area
- Blood and lymphatic system disorders
- Decision number
- P/0152/2024
- PIP number
- EMEA-002665-PIP02-20-M01
- Pharmaceutical form(s)
- Powder for concentrate for solution for infusion
- Condition(s) / indication(s)
- Treatment of mature B-cell neoplasms
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
Swedish Oprhan Biovitrum AB (publ)
Email: info@sobi.com
Tel. +46 8 697 20 00- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Ei