MHRA-100111-PIP01-21-M01 (update)

Key Facts

Active Substance
  • Islatravir
  • DORAVIRINE
Invented Name
Not yet available
PIP Number MHRA-100111-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age appropriate solid dosage form (Granules for oral suspension)
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
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
05/09/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100111-PIP01-21-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ISLATRAVIRDORAVIRINE.pdf
Published Date 14/04/2026