EMEA-002075-PIP01-16-M03 - paediatric investigation plan

Lefamulin

Key facts

• Invented name:
  Xenleta
• Active substance:
  Lefamulin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0535/2022
• PIP number:
  EMEA-002075-PIP01-16-M03
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Age appropriate oral solid dosage form
  • Coated tablet
• Condition(s) / indication(s):
  Treatment of community-acquired pneumonia
• Route(s) of administration:
  • Intravenous use
  • Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/12/2022
• Compliance check done:
  Non

Decision

P/0535/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lefamulin (Xenleta) (EMEA-002075-PIP01-16-M03)

Adopted Reference Number: EMA/901112/2022