MHRA-102542-PIP01-26-M01 (update)

Key Facts

Active Substance
Active Substance:
  • CEFTOBIPROLE MEDOCARIL SODIUM
Invented Name
  • Zevtera and associated names
  • Zevtera
  • Mabelio
  • Zevtera
  • Zevtera
  • Zevtera
  • Mabelio
  • Mabelio
  • Mabelio
  • Zevtera
  • Zevtera
  • Zevtera
  • Zevtera
  • Adaluzis
  • Zevtera
  • Zevtera
PIP Number MHRA-102542-PIP01-26-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of pneumonia
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
20/07/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-102542-PIP01-26-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):CEFTOBIPROLE MEDOCARIL SODIUM.pdf
Published Date 04/09/2026