EMEA-001555-PIP01-13-M05 - paediatric investigation plan

eravacycline

Key facts

• Invented name:
  Xerava
• Active substance:
  eravacycline
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0397/2023
• PIP number:
  EMEA-001555-PIP01-13-M05
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of complicated intra-abdominal infection
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/10/2023
• Compliance check done:
  Não

Decision

P/0397/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for eravacycline (Xerava), (EMEA-001555-PIP01-13-M05)

Adopted Reference Number: EMA/468349/2023