EMEA-001687-PIP01-14-M07 - paediatric investigation plan

fostemsavir trometamol

Key facts

• Invented name:
  Rukobia
• Active substance:
  fostemsavir trometamol
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0380/2023
• PIP number:
  EMEA-001687-PIP01-14-M07
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/09/2023
• Compliance check done:
  No

Decision

P/0380/2023: EMA decision of 7 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for fostemsavir (tromethamine), (Rukobia), (EMEA-001687-PIP01-14-M07)

Reference Number: EMA/388640/2023