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

Key Facts

Active Substance
Active Substance:
  • TEDIZOLID PHOSPHATE
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
  • ORAL USE
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
11/07/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100564-PIP01-22-M03-C2

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):TEDIZOLID PHOSPHATE.pdf
Published Date 01/05/2026