MHRA-100690-PIP01-22-M02 (update)

Key Facts

Active Substance
  • IMIPENEM MONOHYDRATE
  • CILASTATIN SODIUM
  • RELEBACTAM MONOHYDRATE
Invented Name
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
PIP Number MHRA-100690-PIP01-22-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for infusion
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of infections caused by gram-negative organisms.
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
26/03/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100690-PIP01-22-M02-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):IMIPENEM MONOHYDRATECILASTATIN SODIUMRELEBACTAM MONOHYDRATE.pdf
Published Date 15/07/2026