EMEA-002183-PIP01-17-M01 - paediatric investigation plan

Imlifidase

Key facts

• Invented name:
  Idefirix
• Active Substance:
  Imlifidase
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0076/2022
• PIP number:
  EMEA-002183-PIP01-17-M01
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Prevention of graft rejection following solid organ transplantation
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Hansa Biopharma AB

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/03/2022

Decision

P/0076/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for imlifidase (Idefirix) (EMEA-002183-PIP01-17-M01)

AdoptedReference Number: EMA/65167/2022