MHRA-101117-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • ORITAVANCIN
Invented Name
  • Tenkasi
  • Tenkasi
  • Orbactiv
  • Tenkasi
  • Tenkasi
PIP Number MHRA-101117-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Powder for concentrate for solution for infusion
  • Age appropriate dosage form for parenteral use.
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI)
Route(s) of administration
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
Yes
Compliance Check Decision Date
Compliance opinion date
13/10/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-101117-PIP01-23-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ORITAVANCIN.pdf
Published Date 19/12/2023