MHRA-102445-PIP01-26-M01 (update)

Key Facts

Active Substance
Active Substance:
  • PRETOMANID
Invented Name
Dovprela
PIP Number MHRA-102445-PIP01-26-M01 (update)
Pharmaceutical form(s)
  • Tablet
  • Dispersible tablet
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of multi-drug-resistant tuberculosis
Route(s) of administration
Route(s) of administration:
  • Oral 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
22/09/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-102445-PIP01-26-M01-C2

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):PRETOMANID.pdf
Published Date 03/11/2026