EMEA-001809-PIP01-15-M03 - paediatric investigation plan

relebactam (MK-7655A)

cilastatin sodium

imipenem monohydrate

Key facts

• Invented name:
  Recarbrio
• Active Substance:
  • relebactam (MK-7655A)
  • cilastatin sodium
  • imipenem monohydrate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0090/2023
• PIP number:
  EMEA-001809-PIP01-15-M03
• 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
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe), Inc.

  Tel. [phone]; Email: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023

Decision

P/0090/2023 : EMA decision of 10 March 2023 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- M03)

AdoptedReference Number: EMA/73513/2023