EMEA-001744-PIP01-14-M02 - paediatric investigation plan

begelomab

Key facts

• Active Substance:
  begelomab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0078/2023
• PIP number:
  EMEA-001744-PIP01-14-M02
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of acute graft-versus-host disease (aGvHD)
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Adienne S.r.l. S.U.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023

Decision

P/0078/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for begelomab (EMEA- 001744-PIP01-14-M02)

AdoptedReference Number: EMA/74601/2023