EMEA-000115-PIP01-07-M13 - paediatric investigation plan

ataluren

Key facts

• Invented name:
  Translarna
• Active substance:
  ataluren
• Therapeutic area:
  Neurology
• Decision number:
  P/0196/2023
• PIP number:
  EMEA-000115-PIP01-07-M13
• Pharmaceutical form(s):
  Granules for oral suspension
• Condition(s) / indication(s):
  Treatment of dystrophinopathy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/05/2023
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000115-PIP01-07-M13
• Compliance opinion date:
  13/10/2023
• Compliance outcome:
  Positive

Decision

P/0196/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ataluren (Translarna), (EMEA-000115-PIP01-07-M13)

Adopted Reference Number: EMA/PDCO/210857/2023