EMEA-002087-PIP01-16-M01 - paediatric investigation plan

Anti-CD7 mAb conjugated to ricin toxin A chain

Anti-CD3 mAb conjugated to ricin toxin A chain

Key facts

• Active Substance:
  • Anti-CD7 mAb conjugated to ricin toxin A chain
  • Anti-CD3 mAb conjugated to ricin toxin A chain
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0369/2022
• PIP number:
  EMEA-002087-PIP01-16-M01
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of acute graft versus host disease
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Xenikos BV

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/09/2022

Decision

P/0369/2022: EMA decision on the acceptance of a modification of an agreed paediatric investigation plan for dafsolimab setaritox/grisnilimab setaritox (EMEA-002087-PIP01-16-M01)

Reference Number: EMA/697762/2022