EMEA-002807-PIP01-20-M01 - paediatric investigation plan

Durlobactam / sulbactam (SUL-DUR)

Key facts

• Active substance:
  Durlobactam / sulbactam (SUL-DUR)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0476/2022
• PIP number:
  EMEA-002807-PIP01-20-M01
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of infections due to organisms of the Acinetobacter baumannii-calcoaceticus complex
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2022
• Compliance check done:
  No

Decision

P/0476/2022 : EMA decision of 1 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for durlobactam / sulbactam (SUL-DUR) (EMEA-002807-PIP01-20-M01)

Adopted Reference Number: EMA/873551/2022