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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):AVIBACTAMCEFTAZIDIME.pdf
Published Date 25/05/2023