EMA/PE/0000232777 - paediatric investigation plan

zosurabalpin

Key facts

• Active substance:
  zosurabalpin
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000232777
• PIP number:
  EMA/PE/0000232777
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of infections due to organisms of the Acinetobacter baumannii-calcoaceticus complex
• 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:
  16/05/2025
• Compliance check done:
  No

Decision

EMA/PE/0000232777 : EMA decision of 16 May 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral for zosurabalpin

Adopted Reference Number: EMADOC-1700519818-2113581