MHRA-100618-PIP01-22-M01 (update)

Key Facts

Active Substance
  • AVIBACTAM
  • CEFTAZIDIME
Invented Name
Zavicefta
PIP Number MHRA-100618-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for concentrate for solution for injection
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
  • Treatment of intra-abdominal infections
  • Treatment of urinary tract infections
  • Treatment of pneumonia
  • Treatment of infections due aerobic 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
09/11/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100618-PIP01-22-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):AVIBACTAMCEFTAZIDIME.pdf
Published Date 01/05/2026