EMEA-001270-PIP01-12-M07 - paediatric investigation plan

oritavancin (diphosphate)

Key facts

• Invented name:
  Tenkasi (previously Orbactiv)
• Active substance:
  oritavancin (diphosphate)
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0074/2024
• PIP number:
  EMEA-001270-PIP01-12-M07
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Age appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Treatment of acute bacterial skin and skin structure infections
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/03/2024
• Compliance check done:
  No

Decision

P/0074/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for oritavancin (diphosphate) (Tenkasi), (EMEA-001270-PIP01-12-M07)

Adopted Reference Number: EMA/28203/2024