MHRA-101212-PIP01-23-M01 (update)

Key Facts

Active Substance
  • CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
  • enmetazobactam
Invented Name
EXBLIFEP
PIP Number MHRA-101212-PIP01-23-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 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
19/12/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-101212-PIP01-23-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):CEFEPIME DIHYDROCHLORIDE MONOHYDRATEenmetazobactam.pdf
Published Date 30/04/2024