EMEA-001758-PIP01-15-M02 - paediatric investigation plan

Lumicitabine

Key facts

• Active substance:
  Lumicitabine
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0362/2017
• PIP number:
  EMEA-001758-PIP01-15-M02
• Pharmaceutical form(s):
  Powder 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
  • Gastric use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2017
• Compliance check done:
  No

Decision

P/0362/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for lumicitabine (EMEA- 001758-PIP01-15-M02)

Reference Number: EMA/762994/2017