MHRA-100564-PIP01-22-M03 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
Invented Name
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
PIP Number MHRA-100564-PIP01-22-M03 (update)
Pharmaceutical form(s)
  • Powder for concentrate for solution for infusion
  • Film-coated tablet
  • Powder for oral suspension
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of acute bacterial skin and skin structure infections
Route(s) of administration
  • Intravenous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):TEDIZOLID PHOSPHATE.pdf
Published Date 01/05/2024