EMEA-001809-PIP01-15-M05 - paediatric investigation plan

imipenem monohydrate

cilastatin sodium

relebactam (MK-7655A)

Key facts

• Invented name:
  Recarbrio
• Active substance:
  • imipenem monohydrate
  • cilastatin sodium
  • relebactam (MK-7655A)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0190/2024
• PIP number:
  EMEA-001809-PIP01-15-M05
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of infections caused by gram-negative organisms
• Route(s) of administration:
  Parenteral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2024
• Compliance check done:
  No

Decision

P/0190/2024: EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for imipenem (monohydrate) / cilastatin (sodium) / relebactam (MK-7655A) (Recarbrio), (EMEA-001809-PIP01-15- M05)

Adopted Reference Number: EMA/251740/2024