EMEA-000115-PIP02-09-M03 - paediatric investigation plan

ataluren

Key facts

• Invented name:
  • Translarna
  • Translarna
• Active substance:
  ataluren
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0284/2016
• PIP number:
  EMEA-000115-PIP02-09-M03
• Pharmaceutical form(s):
  Granules for oral suspension
• Condition(s) / indication(s):
  Treatment of cystic fibrosis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/11/2016
• Compliance check done:
  Ne

Decision

P/0284/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for ataluren (Translarna), (EMEA-000115-PIP02-09-M03)

Reference Number: EMA/704430/2016