MHRA-101712-PIP01-24

Key Facts

Active Substance
Active Substance:
  • Tebipenem pivoxil (as the hydrobromide salt)
Invented Name
Not available at present
PIP Number MHRA-101712-PIP01-24
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral dosage form
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of urinary tract infection
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
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):Tebipenem pivoxil (as the hydrobromide salt).pdf
Published Date 18/12/2025