EMEA-000353-PIP02-16-M03 - paediatric investigation plan

Maribavir

Key facts

• Invented name:
  Livtencity
• Active Substance:
  Maribavir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0183/2023
• PIP number:
  EMEA-000353-PIP02-16-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of cytomegalovirus (CMV) infection
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Takeda Pharmaceuticals International AG Ireland Branch

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/05/2023

Decision

P/0183/2023 : EMA decision of 19 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for maribavir (Livtencity), (EMEA-000353-PIP02-16-M03)

AdoptedReference Number: EMA/170667/2023