EMEA-001631-PIP01-14-M05 - paediatric investigation plan

Letermovir

Key facts

• Invented name:
  Prevymis
• Active substance:
  Letermovir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0455/2023
• PIP number:
  EMEA-001631-PIP01-14-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Prevention of cytomegalovirus infection
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/11/2023
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-001631-PIP01-14-M05
• Compliance opinion date:
  23/02/2024
• Compliance outcome:
  Positive

Decision

P/0455/2023 : EMA decision of 17 November 2023 on the acceptance of a modification of an agreed paediatric investigation plan for letermovir (Prevymis), (EMEA-001631-PIP01-14-M05)

Adopted Reference Number: EMA/509228/2023