EMEA-001838-PIP01-15-M03 - paediatric investigation plan

3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-2H-imidazo[4,5-c]pyridine-2-one (JNJ-53718678)

Key facts

• Invented name:
  Rilematovir
• Active Substance:
  3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-2H-imidazo[4,5-c]pyridine-2-one (JNJ-53718678)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0030/2021
• PIP number:
  EMEA-001838-PIP01-15-M03
• Pharmaceutical form(s):
  Powder and solvent for oral suspension
• Condition(s) / indication(s):
  Treatment of lower respiratory tract disease caused by human respiratory syncytial virus (RSV)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/01/2021

Decision

P/0030/2021: EMA decision of 27 January 2021 on the acceptance of a modification of an agreed paediatric investigation plan...(EMEA-001838-PIP01-15-M03)

AdoptedReference Number: EMA/4727/2021