EMEA-001270-PIP01-12-M06 - paediatric investigation plan

oritavancin (diphosphate)

Key facts

• Invented name:
  Tenkasi (previously Orbactiv)
• Active Substance:
  oritavancin (diphosphate)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0104/2023
• PIP number:
  EMEA-001270-PIP01-12-M06
• 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:
  13/04/2023

Decision

P/0104/2023 : EMA decision of 13 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for oritavancin (diphosphate) (Tenkasi), (EMEA-001270-PIP01-12-M06)

AdoptedReference Number: P/0104/2023