MHRA-100564-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • TEDIZOLID PHOSPHATE
Invented Name
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
PIP Number MHRA-100564-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Powder for oral suspension
  • Powder for concentrate for solution for infusion .
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of acute bacterial skin and skin structure infections
Route(s) of administration
  • Oral use
  • 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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):TEDIZOLID PHOSPHATE.pdf
Published Date 07/12/2022