EMEA-001731-PIP01-14-M04 - paediatric investigation plan

meropenem trihydrate

vaborbactam

Key facts

• Invented name:
  Vaborem
• Active substance:
  • meropenem trihydrate
  • vaborbactam
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0530/2023
• PIP number:
  EMEA-001731-PIP01-14-M04
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Gram-negative bacterial infections
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/12/2023
• Compliance check done:
  Nie

Decision

P/0530/2023: EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for meropenem / vaborbactam (Vaborem), (EMEA-001731-PIP01-14-M04)

Reference Number: EMA/513383/2023