EMEA-001640-PIP01-14-M06 - paediatric investigation plan

tezacaftor

ivacaftor

Key facts

• Invented name:
  Symkevi
• Active Substance:
  • tezacaftor
  • ivacaftor
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0406/2021
• PIP number:
  EMEA-001640-PIP01-14-M06
• 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
• Contact for public enquiries:

  Vertex Pharmaceuticals (Ireland) Limited

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/09/2021

Decision

P/0406/2021 : EMA decision of 30 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tezacaftor / ivacaftor (Symkevi), (EMEA-001640-PIP01-14-M07)

AdoptedReference Number: EMA/521972/2021