EMEA-001765-PIP02-15-M04 - paediatric investigation plan

atidarsagene autotemcel

Key facts

• Invented name:
  Libmeldy
• Active Substance:
  atidarsagene autotemcel
• Therapeutic area:
  Other
• Decision number:
  P/0455/2022
• PIP number:
  EMEA-001765-PIP02-15-M04
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of metachromatic leukodystrophy (MLD)
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Orchard Therapeutics (Netherlands) B.V.

  [e-mail]

  Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/10/2022

Decision

P/0455/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for atidarsagene autotemcel (Libmeldy), (EMEA-001765-PIP02-15-M04)

AdoptedReference Number: EMA/775900/2022