EMEA-003149-PIP01-21-M02 - paediatric investigation plan
Odronextamab
PIPHuman
Key facts
- Active Substance
- Odronextamab
- Therapeutic area
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Decision number
- P/0005/2024
- PIP number
- EMEA-003149-PIP01-21-M02
- Pharmaceutical form(s)
- Concentrate for solution for infusion
- Condition(s) / indication(s)
- Treatment of mature B cell malignancies
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
Regeneron Ireland Designated Activity Company
Email: ClinicalTrialDisclosureTeam@regeneron.com
Tel. +1 9048475385- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date