EMEA-003022-PIP01-21 - paediatric investigation plan

recombinant fusion protein linking human frataxin to TAT cell-penetrant peptide (nomlabofusp)

Key facts

• Active substance:
  recombinant fusion protein linking human frataxin to TAT cell-penetrant peptide (nomlabofusp)
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMEA-003022-PIP01-21
• PIP number:
  EMEA-003022-PIP01-21
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of Friedreich's ataxia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/07/2025
• Compliance check done:
  Ne

Decision

EMEA-003022-PIP01-21 : EPAR - EMA decision of 10 July 2025 on the agreement of a paediatric investigation plan and on the granting of a waiver for recombinant fusion protein linking human frataxin to TAT cell-penetrant peptide

Adopted Reference Number: EMADOC-1700519818-2259558