EMEA-001379-PIP01-12-M06 - paediatric investigation plan

tedizolid (phosphate)

Key facts

• Invented name:
  Sivextro
• Active Substance:
  tedizolid (phosphate)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0050/2022
• PIP number:
  EMEA-001379-PIP01-12-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Powder for concentrate for solution for infusion
  • Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of acute bacterial skin and skin structure infections
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe) Inc.

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/02/2022

Decision

P/0050/2022 : EMA decision of 24 February 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tedizolid phosphate (Sivextro), (EMEA-001379-PIP01-12-M06)

AdoptedReference Number: P/0050/2022