EMEA-003326-PIP01-22 - paediatric investigation plan

Funobactam

Key facts

• Active substance:
  Funobactam
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0370/2023
• PIP number:
  EMEA-003326-PIP01-22
• Pharmaceutical form(s):
  • Age appropriate dosage form
  • Powder for solution for injection or infusion
• Condition(s) / indication(s):
  Treatment of infections caused by Gram-negative organisms (in combination with imipenem and cilastatin)
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0370/2023: EMA decision of 8 September 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for funobactam (EMEA-003326-PIP01-22)

Reference Number: EMA/384157/2023