EMA/PE/0000227394 - paediatric investigation plan

tezacaftor

ivacaftor

Key facts

• Invented name:
  Symkevi
• Active substance:
  • tezacaftor
  • ivacaftor
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000227394
• PIP number:
  EMA/PE/0000227394
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• 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:
  28/01/2025
• Compliance check done:
  Ei

Decision

EMA/PE/0000227394 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for ivacaftor / tezacaftor (Symkevi)

Adopted Reference Number: EMADOC-1700519818-1853205