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
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/09/2022
• Compliance check done:
  No

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